What’s the best Anti-Snoring Device? (Sleep-expert reviews top 13 criteria)

What’s the best Anti-Snoring Device? (Sleep-expert reviews top 13 criteria)

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What’s the best Anti-Snoring Device?

The best anti-snoring device is only prescribed after you’ve been screened for Obstructive Sleep Apnoea / Apnea (OSA).

The best one:

  • Stops your snoring
  • Costs you the least money (because it isn’t a false economy)
  • Creates the least side-effects (and helps you sleep and breathe at the same time)

So, if you’re wondering what’s the best anti-snoring device then read this independent (no advertisements or affiliate links!) sleep-industry expert review.

Despite the lack of prior screening for sleep apnoea, anti-snoring devices (Mandibular Advancement Devices – MADs) or ‘gumshields for snoring’ are big business on the internet and in the pharmacy.

Indeed, the NHS ↗ website makes reference to MADs but fails to differentiate between custom-made and Over-the-Counter (OTC) snore-stoppers!

Adrian Zacher MBA

Adrian Zacher MBA

Author, Snoring and Sleep Apnoea Care Navigator

I teach UK dentists how to help their patients stop snoring; sleep and breathe at the same time.

Many of my customers find their work so rewarding they devote their practice to it. I’m a sleep-industry insider with a quarter of a century of sleep medicine experience.

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Are you a dentist interested in prescribing anti-snoring devices?

We help you to help your patients to stop snoring (and stay indemnified).

So, the challenge as a hasty snorer is:

How to choose one that actually works?!

Snoring aids and cures are increasingly popular as we recognise the impact poor sleep has upon our health, daytime functioning and work performance.

A news article “Ten Snoring Cures” reviewed 10 ‘cures’ available in the UK. The journalist tried to stop his own snoring, with chin straps, sprays, pillows and ‘gumshields’, aka anti-snoring devices.

He had little success and concluded his review by quoting a snoring expert, Consultant Respiratory Physician, Dr Tom McKay, from Edinburgh Royal Infirmary Sleep Centre, UK, as saying:

Good to know:

Snorer.com is independent. We don’t sell anti-snoring devices, chin straps or whatever! And we don’t benefit from affiliate deals.

A note about mouth opening and nasal breathing:

If you have difficulty breathing through your nose, address this before you consider an oral appliance. Consult your GP if the issue persists.

While an oral appliance should not stop you breathing through your mouth, it will certainly present a restriction.

Nasal breathing is ideal. Read more about this in my post about snore-relief products available without prescription.

‘Sprays don’t have any great effect although nasal steroids have a small role if you’ve got nasal congestion. It can help to lose weight or avoid alcohol last thing at night or to sleep lying on your side. Various forms of gumshield are reasonably successful – maybe 50 or 60 per cent.’

So, its a reasonable question to ask….

Which Anti-Snoring Devices really work?

‘Gumshields for snoring’ could more accurately be described as mandibular advancement devices (MADs). They are also known as intra-oral devices, mandibular repositioning devices (MRDs) or even sometimes mandibular advancement splints (MAS) !

But there are essentially just two categories:

  Over-the-Counter (OTC) ‘gumshields’
  Prescription, Custom-Made Dental Appliances

In this updated for 2019 review, I examine how both categories of anti-snoring device measure up against my Top 13 criteria for choice (see call out box) to determine which ones really work, and if they’re safe and effective.

And the best bit?

Each section concludes with my verdict and there’s a free bonus at the end!

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If you are looking for impartial advice about snoring from an expert in the field, the highly respected Adrian Zacher should be your go to. We applaud Adrian’s work, to raise awareness about the health implications of snoring, and the importance of prescription, custom-made devices for long-term success.

Lucie Ash Director Somnowell Snorer.com September 7, 2018

CAUTION: Snoring may be a symptom of Obstructive Sleep Apnoea / Apnea (OSA)

Snoring may be a symptom of obstructive sleep apnoea/apnea (OSA).

Without first being screened for OSA your purchase of an OTC anti-snoring device, could harm you and if you snore because you have undiagnosed Obstructive Sleep Apnoea (OSA) the OTC gadget delays effective (and free on the NHS!) treatment that will prolong your healthy life.

Get signposted to the most appropriate professional (it’s free!)

The professional will screen you for OSA and decide if you’re ‘just’ a snorer or if your snoring needs investigating.

Your GP may be able to help you – but they may not know much about sleep apnoea as sleep is not part of core medical training. We provide expert written GP Guidelines to help.

In the UK, you can also find sleep-trained dentists who can screen you and recognise Obstructive Sleep Apnoea/Apnea (OSA) symptoms2, make custom anti-snoring devices for snorers, without a prior medical diagnosis, or if they suspect OSA refer you on for further investigation.

Oral appliance therapy is considered a second-line option for OSA (which means that PAP is first-line [the first treatment option] and only after PAP failure would an oral appliance for OSA be considered).

Learn more about dental appliances for sleep apnoea.

Clinical evidence (proof) that the MAD works

No. 1. Clinical evidence (proof) that the Anti-Snoring Device works

What does 'clinical evidence' actually mean?
Medical and dental experts review medical devices (clinical research) to establish if they work. Their research produces data and information which can be thought of as ‘proof’ that something does or does not work, and how well it works in certain circumstances. The evidence they create is also judged for quality.

Judging Anti-Snoring device (MAD) research quality

When selecting an anti-snoring device, it’s important to look at this clinical evidence. To judge the quality of a mandibular advancement device’s (MAD’s) clinical research evidence, you need to look past the headlines claiming “Clinical research– tick”.

What was the outcome of the research?!

Typical patient-centred measures of outcome

Measurement of what patients perceive as important effects from wearing an MAD typically include:

  • Partner reported snoring (derrr… a no-brainer!)
  • Daytime sleepiness
  • Quality of life
  • Adherence (long-term use)
  • Device preference
Gumshields for snoring
Gumshields or ‘Boil-and-Bite’ anti-snoring devices, have been clinically researched head-to-head against custom-made, prescription, adjustable anti-snoring devices and found to be lacking.

Our results suggest that the thermoplastic device cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy.3

…patients overwhelmingly found the ready-made MRD difficult to tolerate…4

…96% of patients reported minor adverse events, which related predominantly to discomfort.4 [referring to a study by Dr. Tim Quinnell 5

Prescription, custom made MADs
Today, clinical research has established that custom made MADs are first-line therapy (the default first option) for snoring and mild obstructive sleep apnoea / apnea.

MAD research now focuses on:

Predictors of satisfactory outcome before purchase (who will benefit and why) and which type of custom made MAD is most effective for a given genotype (which MAD is best for YOU as opposed to a vanilla approach).

Expert’s verdict on clinical evidence for MADs
It is not enough to say that an MAD has been clinically researched. Such research may have proved the MAD didn’t work!

A positive outcome from clinical research can be thought of as a ‘guarantee’ of sorts.

My advice is to do your homework (grab the Bonus Mouthpiece Guide at the end) and be guided by a sleep-trained dentist. You can find one on via our Links new window page.

[Note: Below is an advanced topic about typical MAD research metrics. So, if you’re new to clinical evidence, feel free to skip this tip].

Typical Mandibular Advancement Device (MAD) research quality metrics include:
  • Total sample size (the ‘N’ or number of patients who used the device)
  • Could they tolerate it in their mouth (known as tolerance)
  • How many hours they used it for each night (known as compliance)
  • How many nights they used it for per week (part of the compliance metric)
  • Partner reporting of cessation of snoring
  • Perceived sleepiness before and after use
  • Before and during use blood oxygenation level
  • Before and during use AHI (apnoea hypopnea index – an index used to indicate the severity of sleep apnea. The number of apnea and hypopnea events per hour of sleep)
  • Whether a placebo was used with a control group
  • Whether patients crossed over to a different therapy / device
  • Whether the researchers and/or patients were ‘blind’ (who was aware which device was a placebo or an actual MAD?)
  • Has the research been published in a high profile and peer-reviewed journal? (This means other experts in the field judge it for quality)

No. 2. Anti-Snoring Device costs

OTC gumshields and ‘treatments’ might appear cheaper than custom-made, prescription appliances & dentist fees, BUT…

Are they a false economy?

Why use a dentist to get an Anti-Snoring Device (MAD)?

Financially, its tempting to cut out the dentist.

After all, a large part of the cost to you when purchasing a mandibular advancement device, is their clinical time.

The device fees vary, but what are you paying for?

Dentists know about teeth, gums and jaw-joints
That is what they do.

While Dentistry may initially seem expensive, the risks of not using an expert are considerable. Remember, you are relying on the anti-snoring device to hold open your airway while you sleep. Think carefully before you choose.

Some dentists are specially trained in snoring and sleep apnoea / apnea, known as sleep-related breathing disorders (SRBD) and work closely with medics. Dentists with a special interest in sleep, can help you find the correct balance of benefits versus side-effects.

If you have certain medical conditions, or grind your teeth, you might break an OTC ‘gumshield’ whilst you’re asleep. When you are asleep you cannot spit out pieces of a broken gadget. You could INHALE or SWALLOW pieces.

You can find sleep-trained dentists on our Links page. In the UK, look for the British Society of Dental Sleep Medicine.

Expert's verdict on whether to cut out the dentist
Don’t do it.

The terrifying thought of bits of MAD breaking off and being inhaled while you sleep, should surely make you realise you need to see a sleep-trained dentist and use a prescribed custom-made, adjustable anti-snoring appliance, made to quality standards.

In case you’re wondering, I’m not a dentist.

Anti-snoring device (mandibular advancement device - MAD)

Example of a custom-made Mandibular Advancement Device (MAD). Image above used with permission from SomnoMed.

Mandibular Advancement Device (MAD) made from metal

Example of a custom-made Mandibular Advancement Device (MAD). Image above used with permission from SomnoWell.

When it's time to stop:

Get signposted (free) to the right professional. Saving you time and helping to alleviate pressure on GP practices

over the counter: anti-snoring devices

Tired of the sleepiness and the snoring?

Then read our free, definitive step-by-step how to stop snoring Guide.

This comprehensive Guide walks you through self-help, signposting, screening, professional assessment and diagnosis, the three categories of prescription treatment, follow-up and rounds off with a substantial FAQ.

No. 3. Comfort and bulk of Anti-Snoring Devices (MAD)

An MAD that is so uncomfortable to wear, soon ends up being thrown across the bedroom or just left in the bathroom at bedtime…

Both the design and clinical expertise in how an anti-snoring device is supplied, directly impacts your likelihood of successfully wearing it (and therefore whether it stops your snoring) – particularly during the first two weeks of use.

This is when most people who aren’t going to get on with them, quit. It might seem obvious:

but if you don’t wear it – it doesn’t work.

OTC gumshields for snoring (Boil-and-Bite)
Generally OTC gumshields for snoring are “one-size-fits-all”.

They have to be bulkier in size to adapt to your teeth than custom-made devices. This would mean it feels like you are squeezing a tennis ball into your mouth – Oh, and then you’re expected to sleep!

Custom-made MADs
A sleep-trained dentist will ensure that your MAD fits properly and doesn’t hurt.

They will also ensure you know how to put the device into your mouth and get it out again.

Expert's verdict on comfort and bulk
As a general rule, custom-made anti-snoring devices are less bulky than ‘gumshields’.

Due to the lack of accuracy of the ‘fit’ and one-size-fits-all approach of gumshields, they may be too large, too small or take up so much room in your mouth you can’t close your lips and you find yourself dribbling attractively!

Warning! Is this the best anti-snoring device for you? UK expert review

No. 4. Will an Anti-Snoring Device (MAD) damage my teeth and gums?

You wear these things in your mouth.
What impact will it have?

Gumshields for snoring (So called 'instant anti-snoring devices')
Its quite possible that a gumshield will place excessive load upon an individual tooth/teeth.

Over time your teeth will move. It will hurt.

And you will either stop wearing the mandibular advancement device and accept the financial loss (good luck trying to get a refund on a used product), or under duress from your partner and family, continue wearing it and risk losing the tooth or an expensive crown/cap/bridge.

Prescription, custom-made MADs
Prescription Mandibular Advancement Devices on the other hand, can be designed to avoid certain teeth if they are identified as at risk.

An expert sleep-trained dentist can help identify (and save that tooth) if it could not withstand the lateral loading required.

A dental technician would ‘block out’ the identified tooth and not include it in the custom-made device.

Expert's verdict on risk to your teeth and gums

All anti-snoring devices will aggravate your oral hygiene. 

However, a sleep-trained dentist would ensure BEFORE you had an MAD, that your hygiene and oral condition (teeth, gums and jaw-joints) were satisfactory before you began to use it.

Try to keep the device as clean as possible. Use your toothbrush and toothpaste on it each morning. Don’t use chlorine based denture cleaners on gumshield based devices – it makes them hard and brittle (unusable) rapidly. Instead, use a baby bottle sterilising fluid (follow the manufacturer’s instructions).

Brush and floss your teeth carefully and consider using a chlorhexidine mouthwash. If you spit blood when you clean your teeth consult a dentist/hygienist.

‘Boil-and-Bite’ devices will flex when worn and over time, this will procline (tilt forwards) your lower incisors and retrocline (tilt backwards) your upper incisors.

Certain custom-made anti-snoring devices are designed to avoid this tooth tilting movements.

Consult your sleep-trained dentist.

No. 5. Will an Anti-Snoring Device damage my jaw-joints?

Jaw pain is truly horrible and once you have a jaw pain problem it persists.

All types of mandibular advancement device (MAD) work by moving your lower jaw forwards, and the amount it does this to be effective, and not hurt too much, is specific to you.

Gumshields for snoring
Some gumshields for snoring are only adjustable in large increments, while others you have to fit the device – rather than the device actually fit you (again you may lose your money).
Custom-made MADs
Custom made, adjustable, prescription MADs really win when considering your jaw joint. In fact, it’s possible, with some of the custom made ones to start off wearing it with no (or very little) change in your jaw position.

While of course it won’t initially prevent snoring in this position, the dentist will gradually advance your jaw until you stop snoring over a matter of weeks or perhaps even longer (this is known as titration). This gives you, your device (and your jaw joint) time to get accustomed.

Which means you STOP SNORING!

And don’t permanently harm yourself. Yay!

Expert's verdict on jaw-joint risk
Your sleep-trained dentist will screen you for sleep apnoea, assess your teeth, gums and examine your jaw joints.

They will take X-rays and put things right beforehand if necessary. If it doesn’t look like its a good idea, they’ll suggest:

  • You DON’T have one,
  • Explain why,
  • And direct you to appropriate help.

If everything is OK, they’ll monitor the effect the MAD is having upon your teeth, gums, jaw joint and snoring.

If your jaw joint isn’t healthy before you start using an anti-snoring device then it may cause irreversible harm. (The exception is when a specialist sleep and jaw joint pain [Temporo-Mandibular Joint Dysfunction or TMD] dentist prescribes a device for BOTH issues.)

A sleep-trained dentist would know what to avoid and ensure you did not experience premature posterior contact (see call out box) that would damage your jaw-joint.

Premature posterior contact

This gets a bit technical.

A common problem particular to ‘gumshields’ occurs when the device is adjusted forwards known as ‘protrusion’ (you might do this in an attempt to increase the effect – and stop the snoring noise). The upper and lower parts of the device may then come into contact on just your back teeth.

This acts like a ‘bit’ for a horse – it gives you something to chew on. It ‘gags’ open the bite (keeps your jaws more open than they should be) and this uneven bite places enormous load on your jaw joints.

It would be even worse for your jaw joint, if this was on one side only, and as you close your mouth, your jaw has to ‘rotate’ around this ‘premature contact’. What the above means, is that your jaw has to move in unnatural ways.

This hurts. And if you use the device in this position (because you’re trying to appease your partner) you will irreversibly damage your jaw joint.

No. 6. Retention /  Fit of your Anti-Snoring Device (MAD)

How well your anti-snoring device fits, is known in dental terminology as ‘retention’.

But retention has two meanings in Dental Sleep Medicine (DSM is the term for MADs used to help with sleep-related breathing disorders, including snoring and OSA).

The first meaning is how well it keeps hold of your teeth, or to put it another way, how well it ‘clips on’ or stays in place. 

Most MAD designs rely upon its ability to ‘clip’ into place to then be able to hold your jaw forwards – and stop you snoring.

The second DSM interpretation of ‘retention’ relates to the MAD’s ability to hold open your airway, retain it in a forward position, and prevent you from snoring.

So, the right amount of retention (or fit) is essential for it to work.

Over-the-Counter ‘gumshield’ vendors make their money by relying on you being too lazy to seek a refund when it doesn’t work.

Read my review of ways they separate you from your money. ↗

Gumshields and retention
This is unavoidably technical. So, feel free to skip to my verdict.

Due to the necessary choice of thermo-plastic (it softens and becomes adaptable to you, when heated in boiling water) material used in ‘boil and bite’ devices, getting and keeping the right degree of retention, for the long-term is nigh on impossible.

The material ‘wants’ to go back to its original shape as it cools down, which is technically due to both the elastic memory and elastic recovery of the material. There’s more about the material used in the Lifespan or ‘Cost per wear’ section below.

Custom-made MADs
Custom-made dental devices for snoring are made for you (on prescription) from raw materials by a registered dental technician. While the materials used vary, they usually only become thermoplastic (soften when warmed up) when heated over 100 deg C.

On the other hand, ‘Customised fit‘ devices are the ‘Boil-and-Bite’ gumshield type of MAD (and I know you know water boils at 100 deg. C!).

Expert's verdict on retention of Anti-Snoring Devices
Boil-and-Bite gumshields for snoring as a general rule, cannot provide good retention.

Without good retention or ‘clip’ to your teeth, gumshields will not stop you snoring. End.

No. 7. Can I adjust the position of my Anti-Snoring Device (MAD)?

The ability to adjust the forward position of your jaw (adjust the protrusion to prevent snoring) impacts upon both comfort and how well it works.

The optimum position is unique to you. It has to be just far enough forward to prevent you from snoring, yet not so far forward, it hurts your jaw joints.

Fixed devices (sometimes called ‘monobloc’ devices) take an arbitrary approach to the forward position of your lower jaw. This primitive design (exhibited by both over-the-counter gumshields and some old tech custom-made ones) is likely to be less than ideal for comfort and effect.

Gumshields for snoring
For the MAD to prevent snoring it must prevent your mouth from falling open.

You should NOT need a chinstrap in addition to your anti-snoring device. If a chin straps is suggested then:

You need a different MAD.

If you’re trying to ensure you breathe through your nose and stop your mouth falling open, then read Chinstraps for snoring? Safe, Effective or Dangerous? [new window]. In my chin strap review, I examine if they have a role for snoring and obstructive sleep apnea (OSA).

If you can only breathe through your mouth and/or sometimes struggle to breathe through your nose, then consult your GP and seek an ENT assessment.

Custom-made, adjustable MADs
Custom-made, adjustable MADs are inherently adjustable (the clues in the name!)

The important thing to understand about adjustable MADs relates to their range of movement, and:

  • Whether this is sufficient
  • Whether it dictates a hard to tolerate initial position

The most modern custom-made adjustable MADs have between 8-10mm range of movement. If more is needed – you will most likely need a remake (more money).

Expert's verdict on ability to adjust the protrusion
Clearly, fixed or monobloc devices fail this test 🙂 A new anti-snoring device would need to be made if the jaw position was incorrect. Adjustable anti-snoring devices need to have sufficient range of motion to coincide with your jaw range of motion – or you must start in a forward jaw position, which may impact your ability to get along with the MAD initially.

No. 8. Life-span or ‘cost-per-wear’ of your Anti-Snoring Device

To ensure your purchase of an anti-snoring device (MAD) is not a waste of money or a false-economy, you have to consider:

  • Its outright price (don’t forget the clinical fees) and VAT (if its for snoring)
  • Its length of useful life

Amongst other things…

Gumshields for snoring
A material that softens in boiling water called ‘Ethylene Vinyl Acetate (EVA) or EVA’ is commonly used in gumshield type anti-snoring devices.

  • This material absorbs saliva from your mouth (and also any cleaning chemicals that may then leak back out into your mouth overnight – nice).
  • They are damaged if you grind your teeth because the material is soft and elastic.
  • Their typical lifespan is 6 months to 1.5 years before the EVA constructed gumshield becomes too smelly and unpleasant to use.
  • They also distort and place high lateral loads on your front teeth – making them very sore in the morning.
Custom-made Anti-Snoring Devices
Some early design variants of custom-made anti-snoring devices, are also made from EVA ‘blow down’ or vacuum formed blanks of CE marked material by a registered dental technician.

However, most are typically made from a type of denture acrylic (polymethylmethacrylate) or ‘PMMA’, and as such are stronger and less likely to absorb saliva than EVA materials. Some new variants are made from a type of ‘Nylon’ (polyamide) and are very strong in thin section (see Comfort and bulk above). This means they will last longer and therefore the ‘cost per wear’ may be reduced.

In the UK, it is also possible to obtain a custom-made anti-snoring device manufactured entirely from metal (known as ‘Chrome’ = Cobalt chrome wiki link: http://en.wikipedia.org/wiki/Cobalt-chrome new window ) While this type of manufacture may cost more (they are more time consuming to make) the material cross-section is extremely thin (fractions of a millimetre are possible) making the bulk in your mouth minimal (see comfort and bulk above). Additionally, the metal device does not absorb saliva or cleaning agents.

The downside is that any adjustment of ‘fit’ of metal devices may be problematic and over time the clasps (bits that wrap around your teeth to hold [retain – remember that?] the device in your mouth) may ‘relax’ and need adjusting.

Expert's verdict on lifespan of MADs
Broadly speaking its a sliding scale of cost versus lifespan.

The high-end devices using nylon or chrome are thinner and less bulky but are also difficult (if not impossible) to adjust. This does not mean to say its a problem, they just have to be perfectly made.

So, if its not – then it needs to be remade: Do not accept a poor fitting custom made anti-snoring device.

No. 9. Control of mouth opening (Does the MAD do it?)

When using a mandibular advancement device (MAD) it is essential that your mouth does not fall open for effective snoring relief, which if permitted would make your airway narrower than it would be without a mandibular advancement device!

It should not be necessary to resort to a chin strap to control this. Yes, I’ve been over this point in point 6 Retention above, but…

Why does vertical opening matter?

The lower jaw rotates backwards as it opens which further narrows your airway and makes snoring worse (or if you have sleep apnoea / apnea may increase the severity and duration of apnoeaic episodes).

If your jaw is protruded with a mandibular advancement device (MAD) and your jaw falls open your airway may be narrower than without using an MAD.

See the three X-ray diagrams below, to understand why vertical opening with an MAD should be avoided. The red dots highlight how the airway increases / decreases with protrusion and vertical opening.

Images courtesy of Dr Ulrich Huebers DDS.

The diagram (below left) shows the size of the airway in your throat without a mandibular advancement device (MAD).

The diagram (below centre) shows the ideal situation. The mandibular advancement device advances the jaw and opens the airway in your throat.

The third diagram (below right) shows how the airway becomes narrower with both protrusion and vertical opening. Disaster.

rest position before a mandibular advancement device
Mandibular Advancement Device (MAD) with NO vertical opening in protrusion
mandibular advancement device
Gumshields and custom-made MADs
Both categories of MAD (Boil-and-Bite gumshield and custom-made MADs) can fail when examined against this important test metric.

  • Jaw advancement must increase as the mouth opens (protrusion must increase proportionally [to maintain the same effect] if vertical opening occurs).
  • Less protrusion correlates with:
    1. Less side-effects (including less risk of tooth movement and jaw pain)
    2. Increased tolerance and improved long-term compliance.

An interincisal opening (the distance measured between the upper and lower front teeth) of more than 5 mm has been associated with lower patient adherence (long-term use), perhaps as a result of discomfort.6

Expert's verdict on mouth opening

Minimal vertical opening (as in just sufficient to permit the lower jaw to advance without the upper and lower teeth hitting each other) should routinely be considered ideal. More than this may be necessary in selected cases where:

  • the tongue is large
  • the jaw is small

However, opening beyond 5mm (measured between the incisors) is uncomfortable, inhibits lip closure and detrimentally impacts long-term use. A design principle for MADs is control of vertical opening (note my previous comment about not needing a chin strap).

Finally, consider your sleep position. Avoid sleeping on your back and ensure that your neck is inline with your body. Choose a supportive pillow. Learn more about positional therapy and anti-snore pillows.

No. 10. Ability to move side-to-side (lateral movement)

It might seem obvious, but unless the MAD is worn, it cannot stop your snoring.

As such, it must be comfortable to use. Part of this comfort equation is the MAD not creating a ‘trapped’ sensation.

This may occur when the lower jaw is unable to move from side-to-side.

Gumshields and custom-made MADs
Some MADs (both custom-made and ‘Boil-and-Bite’) exhibit the capability to move laterally (side to side) while some do not. My viewpoint is that you should look for one that does permit movement.
Expert's verdict on lateral movement
If you grind your teeth (brux) then this will significantly impact the life-expectancy of your MAD. In fact, you may work harden metal components necessitating their earlier replacement, than would otherwise be expected.

Finally, while it is perhaps a contentious area, if you routinely ‘brux’, then an anti-snoring device that does not permit side-to-side (lateral) movement may actually disrupt your sleep. One theory suggests that this is because your attempts to move are hindered.

The opposing theory suggests you will no longer brux when your apnea is resolved. The jury is out.

No. 11. Does the Anti-Snoring Device mechanism invade your tongue-space?

Ever had a filling or a crown? You may recall how you were very conscious of it. You probably explored it with your tongue and it felt alien. Every anti-snoring device will feel huge in your mouth when you start to use it.

Consequently, less is more!

 

Less physical presence in your mouth, squashing your tongue, enhances your ability to initially accept it and keep using it – and stop snoring…

The concept behind an MAD is to advance the jaw, and in turn, move the tongue forwards and away from the back of your throat.

This increases your airway dimensions and improves tissue tone, which stops you snoring.

So, when an MAD is too bulky, it squashes your tongue. Which is self-defeating.

Gumshields and tongue space
Typically, gumshields are bulky and squash your tongue. They may even have rough or sharp edges which may cause tongue ulcers.

Technically, this may occur with ‘gumshields’ at the junction between two materials, typically with devices that have a hard-outer shell and a softer thermoplastic liner, or when they are crudely ‘adjusted’ with home equipment i.e. scissors!

Prescription, custom-made MADs

Construction

Some primitive custom MADs are bulky and invade tongue space. Materials technology is continually improving, and thinner cross-section devices are now appearing on the market using laser sintered polyamide (a type of nylon).

While traditionally manufactured metal (known as ‘chrome’) devices are available. These may be expensive to make (as they are labour intensive) and may necessitate plastic and metal combined devices, which builds in failure points (because dissimilar materials exhibit different mechanical properties).

Placement of the adjustment mechanism

The placement of adjustment mechanisms in the tongue space is uncomfortable and counter-productive (see concept note above in introduction to this point). Some early custom MADs used orthodontic screw mechanisms in the palate or inside the lower jaw (lingually).

A sleep-trained dentist will guide you when you choose. To get informed for that conversation download our free, evidence-based How to Choose a Mouthpiece Guide. new window

Expert’s verdict on tongue space invasion
If you can’t wear your MAD, then its pointless having it. Consequently, comfort has to be a pivotal deciding factor when selecting one.

Anything placed where your tongue can contact it, is a negative. Remember less is more, when it comes to MAD design.

No. 12. Easy to Keep Clean (Extend useful life, hygiene)

Consult your dentist and the MAD manufacturer’s instructions on how to clean your MAD.

I would suggest that broadly speaking you should (every time you remove it in the morning) use a toothbrush and toothpaste on the device before/after cleaning your teeth. Floss if you have the enthusiasm and discipline… and consider using a chlorhexidine mouthwash too.

Having worked in this industry for longer than I care to remember, I know that MADs must be:

  • Easy to keep clean
  • Not absorb cleaning fluid or saliva
  • Ideally not have intricate mechanisms to retain food and bacteria
  • Be entirely made of one material

Bacterial biofilm (a slimy film of infectious microbes) will form on the device. It’s important to pay extra attention to your oral hygiene (and keep the MAD clean with a toothbrush immediately you remove it in the morning).

Gumshields for snoring
These materials absorb saliva (and cleaning fluids) so bacteria are drawn into the material itself – not just on the surface. Ewww.
Prescription, Custom MADs
The use of materials with better properties, more suited to long-term use in your mouth, should have less detrimental impact. You will of course need to keep them clean and remove the biofilm – and keep your teeth and gums really clean.

See a dental hygienist if you need assistance keeping on top of this. Its an investment.

Expert’s verdict
Prescription, custom-made MADs utilise materials that are better-suited to long-term use. They are inherently easier to clean and keep clean. This is vital when you consider the number of people who have gum disease (gingivitis) whose condition would be aggravated by an MAD, perhaps to such an extent that they risked losing a tooth.

Top Tip

If you are lucky enough to have a marble bathroom, make sure that the MAD cleaning fluid does NOT splash out (powder or granule type cleaning products are commonly a type of acid that permanently damages marble). Ideally, clean your MAD elsewhere! (Voice of experience! Customer reported the above to me when I ran Zacher Sleep Appliances).

No. 13. Side-effects of Anti-Snoring Devices (Mandibular Advancement Devices)

There’s always a down-side!

Or in ‘English’:

“You don’t get nowt for nowt”

side-effect
The most common side-effect from Anti-Snoring Devices (MADs)
The most common initial side-effect from using anti-snoring devices is related to saliva. Some people find they dribble while wearing the device during the first few weeks of use. Others may find they have a dry mouth.
The next most common side-effect is jaw ache
This is normally transient and may arise during the ‘titration’ period (where the device is adjusted to gradually advance your lower jaw and stop you snoring).

If this occurs, the correct advice is to speak with your dental clinician. It normally resolves itself but do not suffer in silence.

Longer term, changes in the position of your teeth may occur
This is due to the weight of your lower jaw (think gravity) and the muscles attached to it combining to attempt return of your jaw to its normal position. These forces are all transferred to your teeth and their roots.

This is why even the most wonderful anti-snoring devices are NOT suitable for children – because they would act like an orthodontic device and move their teeth in uncontrolled ways (exceptionally an orthodontist may prescribe an anti-snoring device for certain children with particular needs).

Expert's verdict on side-effects
It is really important to keep things in perspective: Not snoring, breathing and sleeping at the same time or perhaps minor tooth movement?

However, as I have highlighted throughout this review all anti-snoring devices have side-effects.

A sleep-trained dentist would screen you for sleep apnoea, help you stop snoring and minimise (and if necessary correct) any side-effects. They also carry professional indemnity insurance and use prescription anti-snoring devices made to quality standards by registered dental technicians.

FREE BONUS

Download our free, NHS England’s Information Standard accredited, evidence-based, expert-written and jargon-decoded Guide

(that’s a mouthful!):

> How to Choose a ‘Mouthpiece’ to Stop Snoring

You’ll learn about your options and be able to make more informed choices.

No registration is required.

All our Guides, including our award-winning snoring and sleep apnoea overview guide are free on:

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If you prefer you can grab the guides on Amazon Kindle (who sometimes insist on a minimum 99p fee).

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If you snore and self-help isn’t cutting it then don’t self-diagnose.

Get signposted to the most appropriate professional to help you. Its free, evidence-based and a simple way to find out if snoring is actually a symptom of sleep apnoea.

NHS England's Information Standard UK
top-selling anti-snoring devices

Summary

This review has examined the best anti-snoring devices, both Over-the-Counter and custom-made, against my top 13 criteria, to help you choose an anti-snoring device that works, and is safe and effective.

My final verdict is that while a ‘boil-and-bite’ gumshield may prevent snoring for a short while (if you fit the gadget) they are ultimately a false economy and won’t work for long (if at all).

Longer-term, if you were to persevere with a ‘gumshield’ for snoring, it would:

  • Create unpleasant and sometimes permanent, unmanaged dental side-effects
  • Potentially irreversibly damage your jaw-joints
  • And it delays potential OSA diagnosis and effective treatment

In conclusion, clinical research3 has established that ‘boil-and-bite’ gumshields are not valid as either a trial or treatment device.

But this is not a definitive guide to OTC anti-snoring device manufacturers’ claims. This is.

The real question

The real question is:

Why do you snore?

My advice is to:

  • Get signposted to the most appropriate professional
  • Get screened for sleep apnoea before you dive into any treatment and learn why you snore

And then you will know how to stop.

Here’s the next step:

Found this useful?

Write a review below, and let me know.

Anti snore pillows seem ideal.

But do they work? Read my review.

1 - 5 out of 5, where 5/5 is the best and 1/5 is the worst


Reviews

Mrs P
Really interesting stuff!
May 24, 2018
    

Really helpful when I was worried about my OH’s snoring. Gave me info on what to worry about. Next stop the GP.


We applaud Adrian’s work
Snorer.com
September 7, 2018
    

If you are looking for impartial advice about snoring from an expert in the field, the highly respected Adrian Zacher should be your go to. We applaud Adrian’s work, to raise awareness about the health implications of snoring, and the importance of prescription, custom-made devices for long-term success.

Expert reviews and ‘How-to’ Guides related to Anti-Snoring Devices:

Here are some more expert reviews about anti-snoring devices, snoring and sleep apnoea / apnea products, cures and aids!

Personally, I hate instant snoring cures as the balance of benefit to risk is generally against you.

Glossary

Anti-Snoring Device – generally considered a product worn in your mouth to stop you snoring.

Boil-and-Bite – a type of gumshield for snoring that may be adapted to you by softening the material in boiling water. See OTC below.

Custom-made – a bespoke device made exclusively for you by a registered dental technician, working to prescription, using CE marked materials. In Europe working to the Medical Devices Directive  administered in the UK by the Medicines and Healthcare Products Regulatory Authority (MHRA).

DSM Dental Sleep Medicine – the management of sleep-related breathing disorders using dental devices.

Gumshield for snoring – see ‘Boil-and-Bite’ above.

Information Standard – NHS England’s Information Standard. Organisations that join The Information Standard are showing their commitment to producing good quality, evidence-based health and care information.

MAD Mandibular Advancement Device – Jaw advancing device, worn at night while asleep to hold forward the lower jaw to stop snoring and prevent obstructive sleep apnoea / apnea.

MAS Mandibular Advancement Splint – See ‘MAD’.

MRD Mandibular Repositioning Device – See ‘MAD’.

OSA Obstructive Sleep Apnoea – (also spelt apnea) When an individual is unable to sleep and breathe at the same time. Visually, a repetitive pattern of breathing interruptions (apnoeas) occurring while the individual sleeps, due to a physical obstruction in the airway.

OTC – Over-the-Counter product sold over the pharmacy counter or on-line without prescription, medical or dental assessment and without a review of medical/dental history.

Signposting – Is the medical term for directing people to the most appropriate professional to help them based upon their answers to some high-level questions.

Sleep-trained Dentist – A dentist that has undergone special interest training in sleep. As such they are able to obtain professional indemnity insurance.

TMD – Temporo-Mandibular Joint Dysfunction. Jaw-ache or pain, due to abnormal or impaired movement.

References

  1. Snoring cures success ‘exaggerated’ http://news.bbc.co.uk/2/hi/health/1701735.stm new window [accessed 16th Oct 2016]
  2. Stradling, J. and Dookun, R. 2009, Snoring and the role of the GDP: British Society of Dental Sleep Medicine (BSDSM) pre-treatment screening protocol, British Dental Journal, 206, 307 – 312. Available here: http://www.nature.com/bdj/journal/v206/n6/abs/sj.bdj.2009.214.html new window [accessed 12 April 2017]
  3. Vanderveken OM, Devolder A, Marklund M, et al, 2008. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. Am J Respir Crit Care Med; 178: 197–202. Available here: http://www.atsjournals.org/doi/abs/10.1164/rccm.200701-114OC#.V9ukcFT_rio new window [accessed 12 April 2017]
  4. Ready-Made Versus Custom-Made Mandibular Repositioning Devices in Sleep Apnea: A Randomized Clinical Trial, Johal A, Haria P, Manek S, Joury E, Riha R. Ready-Made Versus Custom-Made Mandibular Repositioning Devices in Sleep Apnea: A Randomized Clinical Trial. Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine. 2017;13(2):175-182. doi:10.5664/jcsm.6440. Available here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5263072/ new window [accessed 18th June 2018]
  5. A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO). Quinnell TG, Bennett M, Jordan J, Clutterbuck-James AL, Davies MG, Smith IE, Oscroft N, Pittman MA, Cameron M, Chadwick R, Morrell MJ, Glover MJ, Fox-Rushby JA, Sharples LD. Thorax. 2014 Oct; 69(10):938-45. Available here: http://thorax.bmj.com/content/68/Suppl_3/A4.1  new window [accessed 18th June 2018]
  6. Pitsis AJ, Darendeliler MA, Gotsopoulos H, et al: Effect of vertical dimension on efficacy of oral appliance therapy in obstructive sleep apnea. Am J Respir Crit Care Med 166:860, 2002. Available here: https://www.ncbi.nlm.nih.gov/pubmed/12231498  new window [accessed 18th June 2018]

Created by Adrian Zacher | Page last updated 2nd Dec 2019

Dental Gadgets for Snoring: 9 Crazy Claims Sleep-expert Reviewed (2019)

Dental Gadgets for Snoring: 9 Crazy Claims Sleep-expert Reviewed (2019)

Snorer.com
Rated 5/5 based on 16 customer reviews

Dental devices for snoring: available without prescription

Wow! Over-the-counter (OTC) dental devices sound great! 

So, I’m going to show you everything you need to know about their claims.

Researched over 4 years, this comprehensive review, also looks at the regulatory framework governing the device manufacturers.

Do they stop snoring? Are they easy to self-fit?

What else should you know?

Let’s find out…

Adrian Zacher MBA

Adrian Zacher MBA

Author, Snoring and Sleep Apnoea Care Navigator

I teach UK dentists how to help their patients stop snoring; sleep and breathe at the same time.

Many of my customers find their work so rewarding they devote their practice to it. I’m a sleep-industry insider with a quarter of a century of sleep medicine experience.

Google Scholar

Tired of the sleepiness and the snoring?

Then read our free, definitive step-by-step how to stop snoring Guide.

This comprehensive Guide walks you through self-help, signposting, screening, professional assessment and diagnosis, the three categories of prescription treatment, follow-up and rounds off with a substantial FAQ.

Claim 1 – OTC dental devices stop your snoring

After all, that’s what you buy them for…

Verdict: Do OTC dental devices stop your snoring?

Sadly, these gadgets do not always stop snoring. But don’t take my word for it, the BBC, when covering a ‘Which?’ report1 (the UK’s consumer champion) noted, that claims made for their success were an ‘exaggeration’.

Indeed, the BBC report had a callout box stating, “Many snoring products simply don’t live up to their claims”.

in other words… “they don’t work”.

Hmm… It seems lots of OTC dental devices are sold, and the Which? report is a bit old (2001), so could the Beeb and Which? have looked at the wrong devices?

Let’s continue…

Many snoring products simply don’t live up to their claims

Emma Copeland,
Health Which?

stop OTC devices don't work

Claim 2
Does what the expensive ones do

You might think:

I will try this (OTC device) and if it works, then I’ll get a custom one”?

Which on the face of it, seems reasonable…

Verdict – Are they the same as the expensive ones?
Clinical research2 has shown that OTC dental devices bear little resemblance to custom-made ones.

But it’s harmless right?

No.

If you fail with an OTC dental device for snoring, you may also think a custom-made anti-snoring device won’t work, which is known as a ‘false negative’.

This ‘false negative’ delays people getting valid help. Which for the snorer with undiagnosed sleep apnoea, who has tried and failed with an OTC dental device for snoring, is a potentially life-and-death issue.

They may kill themselves (and others) should they fall asleep in unsuitable circumstances

When it's time to stop:

Get signposted (free) to the right professional. Saving you time and helping to alleviate pressure on GP practices

OTC beaten up

Claim 3 – OTC dental devices for snoring are cheap

Over-the-Counter, dental devices for snoring range in cost from approx. £50 – £200 GBP. But remember you’re bypassing medical assessment and diagnosis, and then bypassing the dentist.

DIY appears to save money, but….

 

What are the risks of bypassing Dentists?

Verdict - Are OTC dental devices for snoring actually 'cheap'?
Moving past the medical risks of self-diagnosis for a moment…. which we’ll come to in Claim 5.

Dentists are experts in mouths, teeth and jaw-joints. Bypass them and self-fit your OTC dental devices for snoring and you’re asking for trouble.

Always a pleasure, having failed at DIY, to then ask an expert to clear up after you…

What does the sleep-trained dentist do?
From a dental perspective, if you use an OTC dental device for your snoring you’re ‘going it alone’. The sleep-trained dentist would monitor your teeth for what is known as ‘uncontrolled orthodontic tooth movement’. Which means your teeth tilting in various undesired ways. This could result in a change to how the teeth in your upper and lower jaws bite together (creating what is known as a malocclusion).

That same sleep-trained dentist would also monitor your gums (periodontal condition) and jaw-joints. They wouldn’t prescribe a custom-made, dental device until they were sure it wasn’t going to harm you.

And, if they felt it necessary they would take X-rays to ensure your roots could withstand the lateral loads the device creates – and they carry professional indemnity insurance should anything go wrong…

While perspective is needed when considering tooth movement and breathing, a dentist and a custom-made, prescribed anti-snoring device can limit and control things.

OTC dental devices for snoring ultimately cost you more money and cause you pain
MONEY – perhaps much more than you would spend on a prescription alternative to correct jaw pain, dental and periodontal issues (assuming you don’t lose your teeth or any existing crown & bridge work aka ‘caps’).

PAIN both short-term and perhaps permanent, chronic pain:

SHORT-TERM PAIN if you’re lucky, short-term pain from overloading individual teeth (typically the upper front incisors). This is short-term if you stop wearing the device, resume snoring, ‘put it down to experience’

PERMANENT (CHRONIC) JAW PAIN from an imposed incorrect ‘bite’ (when you close your teeth together). Jaw pain is known as temporo-mandibular joint dysfunction (TMD). It may be caused by devices that don’t close together evenly (known as a ‘premature posterior contact’) or devices that force your jaw to move beyond its limits.

Risky Business
Having tried to wear the OTC device a few nights and found yourself dribbling profusely when it’s in your mouth, experiencing tooth ache and jaw-ache in the morning…. you might now think to return it for a refund.

Nope. You’re unlikely to be successful with any claim on the promoted ‘Money-back guarantee’, because the device is now ‘used’. Gotcha!

Permanent pain and occlusal change

So, OTC anti-snoring devices have other costs, even if financially they at first appear ‘cheap’. They may cause you permanent, chronic pain and occlusal change (which means how your teeth ‘bite’ together).

In 2014, an eminent British dental expert, Dr R.J. Wassell, published in the British Dental Journal4 about ‘Over-the-Counter’ devices (he focused on devices for people who grind their teeth – ‘bruxists’). This is relevant, because he notes OTC devices sold online (and he includes those for snoring and sleep apnoea) are purchased by individuals as a possible alternative to manage their condition, without the need for a dental or medical consultation.

He notes safety information on many internet sites was “notable for its paucity” or was totally lacking.  He points out that manufacturers are not obliged to provide safety information online, but it must be provided with the product and observes that the MAUDE adverse events database5, maintained by the FDA, “showed a number of potentially serious adverse events associated with these splints including choking hazards, tissue damage and occlusal changes”.

Dr Wassell advised the GDC about the OTC device market in 2014. What are we to conclude from their apparent inaction, some 4 years on?

Claim 4 – Easy to self-fit

If you go around professional assessment, ‘treat’ yourself with an OTC gadget and amazingly no longer snore (which is unlikely) you might assume you’re fine.

Are you?

Verdict - Are you OK and are they easy to self-fit?
You should be screened for sleep apnoea before using any dental device for snoring (see Claim 5) and we looked at why going the DIY route (cutting out the dentist) is a bit dumb in Claim 3. However, for the sake of argument, let’s explore this ‘Easy to Self-Fit’ claim.

IF you read the instructions, you’ll learn you must heat up each part and – while its hot – ‘squidge’ (for want of a better word) the device onto your teeth.

Repeat this for the other jaw.

OK, not so bad you might think. But it gets worse…

For some devices, you must do both jaws AT THE SAME TIME and ensure both parts correctly line up. Or it won’t work and you can’t get your money back. Oh don’t forget to make sure it clicks comfortably into place or…

It won’t work.

If the pieces don’t line up – it won’t work – you will have to heat it up again, reform the material and try again. Assuming of course, that the material can withstand another heat cycle…

Try now to claim on the ‘Money-Back Guarantee’. Hah! Good luck with that!

But of course, this is exactly what the OTC dental device for snoring manufacturer wants. They’ve had your money after all – and there’s no comeback on them, if you give up. Regardless of whether it doesn’t work or causes you problems.

All the above assumes you fit the device – i.e. the shape of your mouth and the alignment of your jaws suit the device. Which is totally backwards, it would be like the shops only selling underpants in one or two sizes…

Ouch.

Anti-snoring devices, exist at the point where medicine and dentistry meet

Both are essential

pants

Claim 5 – Quick Fix – No need to wait

Anti-snoring devices, exist at the point where medicine and dentistry meet.

I’ve highlighted the importance of the dental role.

But is a medical assessment essential?

Verdict - Is it a 'quick fix'?
Medical assessment (screening for sleep apnoea at a minimum) for your breathing is a no-brainer. Subsequent dental assessment (should anti-snoring devices be the proposed option), is necessary because the anti-snoring device used to help you breathe, is in your mouth.

Cutting out either professional is, shall we say, ‘foolish’? Bypassing assessment and/or prescription (going the DIY route), is risky because the snorer may have undiagnosed, and therefore untreated, sleep apnoea/apnea.

Claim 6 – Adjustable in protrusion

(How much they push your chin forwards)

Some, but not all, OTC anti-snoring devices are adjustable in protrusion. In either relatively large steps or for more money, with a screw-thread at the front of the mouth, like a ‘volume control knob’!

volume control knob
Verdict - Are OTC dental devices adjustable in protrusion?

The increment technology (approx. 2mm steps) is inherently flawed, because assuming everything else is good…, the difference between an effective position and a painful, impossible to tolerate one, may be much less e.g. 0.5mm.

Outcome: It won’t work

Problems with the volume control
As for the ‘volume control knob’ type, you fit the device in one position and as you adjust it (most likely forwards, because you’re still snoring and think more advancement is required), the ‘biting’ relationship changes. Which changes the alignment of the upper and lower parts of the device, most likely making it hard or even impossible to close your mouth and put your teeth together evenly.

Now, you’re in trouble, whichever way you go:

  • If you persist with the device (because you feel emotionally blackmailed by your partner) and ignore the pain, you risk creating permanent dental and jaw-joint issues. See Claim 3 above.
  • If you stop wearing the device, you’re in ‘hot water’ with your partner, because you’ve ‘quit’ trying to stop snoring…

Oh, and forget the ‘Money-Back Guarantee’ – you’ve used the device. Did you read the small-print? No, thought not.

stop snoring

Claim 7 –
Fits most people’s teeth and jaws

I covered ‘Easy – Self-Fit’ (Claim 4) above, and arguably, yes, the overall shape of OTC dental devices for snoring approximates people’s teeth and jaws BUT,

and here’s the thing:

Verdict - Do OTC dental devices for snoring fit most people’s teeth and jaws?
 

  1. 1OTC dental devices for snoring are inherently bulky (to make them ‘one-size-fits-all’ so they cannot be discrete and comfortable). Which means you may attractively dribble while it’s in your mouth. If it isn’t comfy you won’t wear it, and of course if you don’t wear it – it won’t work.
  2. 2You might struggle connecting the two parts, once in place in your mouth (upper and lower jaw). If you struggle with it – you’re unlikely to wear it – if you don’t wear it – it won’t work.
  3. 3It might not stay in place on your teeth. Your dentist will call this ‘poor retention’. If it doesn’t fit properly then (you guessed it) – it won’t work.

Above, are three more reasons why it’s pointless, struggling in the bathroom mirror with boiling water, squidging bits of hot plastic into your mouth.

Incidentally, custom-made, prescription devices would be remade or professionally adjusted if they exhibited these problems.

You guessed it…  

It won’t work

Where everything gets lost with which Regulator is responsible

I also contacted the Charities Commission because one business, seemed ‘confused’ about its commercial status, variously claiming to be a ‘not-for-profit’ organisation or a Charity.

The result of all the above?

The status quo: Encouraging snorers to DIY their diagnosis, ‘treatment’ and follow-up. Which is wrong on so many levels. 

Regrettably, unlike snorers, the above regulatory organisations are (so far) silent…

As for claiming ‘FDA Cleared’ [FDA means Food and Drug Administration and they control the US market for medical devices]…. my advice is to read what it is cleared for.

OTC devices have been FDA cleared for snoring – not for sleep apnoea/apnea. This means the manufacturers can market them.

But, I must repeat, in the US (just like the rest of the world), there is:

NO WAY to differentiate between snoring and sleep apnoea/apnea symptoms without an overnight sleep study.

Seriously though, after reading this, do you think DIY is sensible? There’s more about the US system in Claim 9 below.

silent
Do You Recall This Materials Scandal?
Relying on a manufacturer’s assertion the product or materials used are safe (which is what you do with an EU Class 1 device, US Class 2 device) leaves you potentially at risk, should the manufacturer not be entirely honest. I’m not saying they’re all dishonest but…

Do you remember this?

French firm, Poly Implant Prothese (PIP) manufactured breast implants using industrial grade silicone not medical device grade7,8. And this was for an implanted medical device (EU Class 3) that should have been tightly regulated. Not something seen as ‘low-risk’ e.g. an OTC anti-snoring device….

Having a professional at least look at the product before you rely upon it to help you breathe while you’re defenceless (asleep) might be considered a good idea!

Surely consulting an expert is no-brainer…?

CE mark

Claim 9 –
OTC dental devices for snoring are: Low-Risk

A bunch of boring but essential rules exist for US and European medical devices. In medical device language, they control how devices are ‘placed on the market’.

Verdict - Are OTC dental devices for snoring 'Low-Risk'?
In the process of researching this, I found some US pre-market notifications (FDA 510k’s) for OTC dental devices for snoring and observed that the FDA review boards for some were ‘dental’ (were any medical professionals involved?).

In Europe, the medical device ‘Class’ is defined by the manufacturer, when they register with the ‘Competent Authority’. If they choose, they may opt for ‘Low-Risk’ (Class I) without any checks on this decision – no external assessment. They may then put the CE mark on their packaging.

OSA trivialised
This trivialises undiagnosed sleep apnoea / apnea

Sadly, EU regulators appear impotent, despite my notification (and notifications by others and also some reputable professional organisations). They fail to protect the Public (yes, I did say that). They continue to allow unscrupulous businesses to sell dental devices for snoring directly to the Public, because the manufacturers have declared the product a ‘low-risk’ Class 1 device.

In May 2017, I happened to visit a leading brand, High Street pharmacy. Amongst the snore-relief products (which irritates me enough) I found an OTC dental devices for snoring that claimed to treat SLEEP APNOEA / APNEA… [lost for words].

——————–

In the US, the FDA does assess whether medical devices are safe and categorised correctly, before they’re sold. The FDA took legal action against one manufacturer9 – yet the device is still available. The FDA did make the manufacturer stop claiming their product treats sleep apnoea/apnea. Consequently, the manufacturer calls it a ‘Snore Relief Device’…

A quote below from an OTC anti-snoring device website Disclaimer (brand name removed), where they proclaim the device is for sale in Europe without a doctor’s prescription and the materials are safe [accessed 22 Oct 2016]:

OTC dental device for snoring Disclaimer - what does this tell you?
Seriously, when you see disclaimers and legal notices like the below on a page – what does it tell you?!

OTC disclaimer

“The XXXXX mouthpiece is designed to cure snoring but the United States, FDA will not allow us to make the claim that our mouthpiece is a cure for sleep apnea, which is a medical condition. Should you suffer from this complaint then you should consult your doctor. While we do not claim to cure sleep apnea, many people have found relief from it as an additional benefit of eliminating snoring with the XXXXX mouthpiece.

Though the FDA won’t allow us to sell the XXXXXX anti-snoring mouthpiece without a doctor or dentist prescription, it is approved for sale in Europe under the European Union Seal of Approval without a doctor’s prescription.

We have deliberately decided to not pursue FDA approval for our product because of the associated costs that we would have to pass on to you, our customer. It has always been our intent to provide a low-cost snoring relief solution. Rest assured, 100% of our product is sourced and made in the USA with non-toxic, latex and BPA-free materials.

It just so happens that the XXXXXX mouthpiece also works very well as a “sports” mouthpiece. That is why we have decided to only sell the very same “anti-snoring” mouthpiece in the United States as a XXXXXX brand “sports mouthpiece”.

Scandalous
Stating: “Should you suffer from this complaint [sleep apnoea/apnea] then you should consult your doctor”, is scandalous. It is impossible to differentiate between snoring and sleep apnoea (unless you’re a sleep-trained expert!) If it was easy, we wouldn’t need Doctors or sleep units….

Arguing the toss, by saying manufacturers comply with the rules, just means the rules are wrong, inadequate or in reality unpoliced. Regardless of which side of ‘the pond’ you are, unscrupulous manufacturers are swerving the existing rules and lack of action by the regulators to sell (in my view) incorrectly categorised products (that should be prescription items), directly to the naïve Public. Buyer beware!

To add insult to injury…. In the UK, dental devices for snoring (both OTC and custom-made) are classified by HMRC as ‘luxury items’10.  Which means they’re standard rated (currently 20% VAT).

What an indictment!

It just goes to show, how poorly sleep-related breathing disorders, of which snoring is one, are understood.

In this way, they’re:

  1. 1Avoiding the cost (and the commercial risk of failure) of a ‘Notified Body’ assessment
  2. 2Gaining access to the whole EU market without external verification of that decision
The correct way to approach a snoring or drowsiness problem:
  1. Professional screening for sleep apnoea using a recognised protocol
  2. Diagnosis if sleep apnoea is suspected
  3. Prescription of the appropriate therapy/treatment

If the proposed treatment is an anti-snoring device, you then have a dental examination prior to being prescribed an appropriate custom-made one.

Although not yet widely adopted, the UK refines this process further by permitting sleep-trained dentists to screen for sleep apnoea6, and in defined circumstances, provide a custom anti-snoring device, without a prior medical diagnosis. Sleep-trained dentist are ideally placed to help simple or ‘benign’ snorers.

This pragmatic solution short-circuits the costly, time-consuming and pointless referral to hospital, of anti-social snorers without sleepiness symptoms or other comorbidities (other related health problems).

The expensive-to-the-system (ask yourself who’s profiting?) alternative, which at the time of writing is current practice in the US and Europe is:

  • For every snorer to be assessed by their GP (Primary Care Practitioner) and then if sleep apnoea/apnea is suspected, referred for further investigation to a sleep centre. This ‘paper assessment’ is time-consuming and requires knowledge that your GP/PCP may not possess.
  • Only for the individual (who after consuming secondary care resources) doesn’t merit treatment with Positive Airway Pressure (PAP) therapy, to then be lost to the system, when they’re ‘advised’ to obtain an anti-snoring device (no formal referral being made due to a silo mentality – see my post about Guidelines for the medical profession).

And they’ve cost the system how many thousands of pounds/euros/dollars? Perhaps in some US States things aren’t so bleak, so perhaps I’m being cynical. But this IS the overall picture.

We’ve been over the medical and dental consequences of buying OTC anti-snoring device, but to summarise:

  • Is BREATHING important to you? Assuming staying alive is important, why would you trust this device to keep your airway open, when you’re ASLEEP?
  • How much would you pay for a pair of glasses (spectacles)?
  • Quite a lot, I imagine because you consider it essential to see. Why then do you think your teeth, gums and jaw-joint are any less important?
  • Do you like to eat without chronic long-term pain in your jaw joint(s)? and to retain your smile?

Illustration of how OTC dental devices for snoring delay Diagnosis and Treatment

Encouraging self-diagnosis and self-treatment to profit from sales of an OTC dental devices for snoring, is irresponsible, harmful to the individual’s health, costly and perhaps dangerous to society.

The step-by-step illustration below is meant to illustrate what typically happens. While fictitious and dramatised, it is based on typical disease progression.11 

 

  1. 1“Johnny Snorer” self-diagnoses his snoring and buys an OTC dental device for snoring online. Miraculously his snoring is silenced, but his undiagnosed sleep apnoea remains untreatedhe remains drowsy during the day, yet doesn’t snore at night.
  2. 2“Johnny” has a near-miss on the motorway because he ‘nodded off’ for a moment. This time, he’s fortunate not to have an accident. He brushes it off and later forgets all about it.
  3. 3“Johnny” is prescribed high blood pressure medication. He falls asleep on the settee immediately after dinner – every night. He never sees the end of the movie. His wife leaves the bedroom after he goes to sleep because his snoring is so bad.
  4. 4He wakes up with a headache every morning, feels hungry all the time, and struggles with his weight. His wife cannot broach the subject of his snoring, because it just ends up in blazing row.
  5. 5“Johnny” has lost interest in sex. His relationship is in crisis, he’s irritable and not much fun to be around. His weight gain is seemingly out of control.
  6. 6“Johnny” is diagnosed with type II diabetes. His GP sends him for dietary advice.
  7. 7His family thinks he “Drives like he’s Drunk” and are very worried about him.
  8. 8His work performance is woeful, and when he has an accident at work through inattention, his employer issues a formal warning and refers him to Occupational Health. His GP refers him for a sleep study.
  9. 9His obstructive sleep apnoea syndrome is diagnosed, some years after he began using an OTC dental device for his snoring.
  10. 10 He begins PAP therapy and rediscovers his love of life. His erectile dysfunction resolves itself and he begins to take exercise. He feels “ten years younger”. He fights to hold on to his job, his home and his family.
  11. 11 Sadly, irreversible damage has been done, to his heart, blood vessels and metabolism. He’s lucky not to have had a stroke.

Conclusion

Time and Money

Everyone likes to save money, but OTC dental devices for snoring are a false-economy, and in my view incorrectly categorised medical devices, that delay sleep apnoea diagnosis and effective treatment.

The personal and socio-economic cost of quite possibly years of mismanaged, undiagnosed sleep apnoea, through the inappropriate sale and use of OTC dental devices for snoring, far exceeds the cost of consulting trained professionals.

Effective, life-transformational, sleep apnoea therapy is NHS funded (it’s ‘free’ in the UK) because it makes economic sense for the NHS to pay for it12.  Businesses that sell OTC dental devices for snoring have flourished in a vacuum because, until now, there has been no viable alternative. Snorers searched online and were easy ‘prey’.

PostScript

I am reliably informed, (name withheld) that should a medical professional, suggest to a snoring patient that they use an Over-the-counter dental device for snoring (self-fit), their professional indemnity insurer would consider them having acted outside their area of professional expertise.

They would then be personally liable for the dental consequences.

Clearly, the correct thing to do, is to refer to appropriate expertise: a sleep-trained dentist. I blogged about the need for Guidelines for the Medical Profession when it comes to oral appliance therapy, in 2012!

Here are two useful resources, if you’re struggling with a snoring problem:

Found this useful?

Let others know what you think.

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References

References

  1. Snoring cures success ‘exaggerated’ http://news.bbc.co.uk/2/hi/health/1701735.stm [accessed 16th Oct 2016]
  2. Vanderveken OM, Devolder A,  Marklund M, et al, 2008. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. Am J Respir Crit Care Med; 178: 197–202. Available here:  http://www.atsjournals.org/doi/abs/10.1164/rccm.200701-114OC#.V9ukcFT_rio[accessed 12 April 2017]
  3. Horstmann, S. et al, 2000, Sleep related accidents in sleep apnea patients. Sleep 1;23(3):383-9.https://www.ncbi.nlm.nih.gov/pubmed/10811382
  4. Wassell, R. J. et al 2014. Over-the-counter (OTC) bruxism splints available on the Internet. British Dental Journal 216. E24. Available here: http://www.nature.com/bdj/journal/v216/n11/full/sj.bdj.2014.452.html [accessed 9th April 2017]
  5. FDA maintained MAUDE database of adverse events: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Search.cfm
  6. Stradling, J. and Dookun, R. 2009, Snoring and the role of the GDP: British Society of Dental Sleep Medicine (BSDSM) pre-treatment screening protocol, British Dental Journal, 206, 307 – 312. Available here: http://www.nature.com/bdj/journal/v206/n6/abs/sj.bdj.2009.214.html [accessed 12 April 2017]
  7. Breast implant register for UK in the wake of the PIP scandal. https://www.theguardian.com/world/2013/dec/29/breast-implant-register-established-pip-scandal [accessed 17th October 2016]
  8. Wikipedia link https://en.wikipedia.org/wiki/Poly_Implant_Proth%C3%A8se#Scandal [accessed 9th April 2017]
  9. The legal fight between the FDA and an OTC anti-snoring device manufacturer: https://www.meddeviceonline.com/doc/legal-brief-anti-snoring-mouthpiece-manufactu-0001 [accessed 8th August 2017]
  10. HMRC VAT Notice 701/57: health professionals and pharmaceutical products https://www.gov.uk/government/publications/vat-notice-70157-health-professionals-and-pharmaceutical-products/vat-notice-70157-health-professionals-and-pharmaceutical-products [accessed 27 Oct 2016]
  11. Punjabi NM. The Epidemiology of Adult Obstructive Sleep Apnea. Proceedings of the American Thoracic Society. 2008;5(2):136-143. doi:10.1513/pats.200709-155MG.
  12. Weatherly, H. et al. 2009. An economic analysis of continuous positive airway pressure for the treatment of obstructive sleep apnea-hypopnea syndrome, International Journal of Technology Assessment in Health Care. Available here: https://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-care/article/an-economic-analysis-of-continuous-positive-airway-pressure-for-the-treatment-of-obstructive-sleep-apneahypopnea-syndrome/2124FA6645420641F224C1A1C75113F1# [accessed 9th April 2017]
  13. ARTP standards of care v.4 http://www.artp.org.uk/en/sleep/sleep-standards/sleep-documents.cfm/sleep-standards-iods [accessed 15th June 2017]

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Created by Adrian Zacher | Page last updated 22nd March 2019

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Dental Appliances for Sleep Apnoea | Snorer.com

Dental Appliances for Sleep Apnoea | Snorer.com

Dental Appliances for Sleep Apnoea

Snorer.com
Rated 5/5 based on 16 customer reviews

What is a Dental Appliance for Sleep Apnoea?

Dental appliances for sleep apnoea / apnea, hold your jaw forwards to aid breathing, while you sleep. They are prescription medical devices, for diagnosed obstructive sleep apnoea (OSA) patients.

If you snore or are worried you may have sleep apnoea (but are not yet diagnosed), then its easy and free to find out, and get signposted to the most appropriate professional to help you.

Go here.

Adrian Zacher MBA

Adrian Zacher MBA

Author, Snoring and Sleep Apnoea Care Navigator

I teach UK dentists how to help their patients stop snoring; sleep and breathe at the same time.

Many of my customers find their work so rewarding they devote their practice to it. I’m a sleep-industry insider with a quarter of a century of sleep medicine experience.

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Dental appliances for sleep apnoea / apnea

How to get a dental appliance for sleep apnoea?

Dental appliances for sleep apnoea are an option for diagnosed obstructive sleep apnoea patients, who are unable to use Positive Airway Pressure (PAP) therapy. PAP therapy is considered the most effective way to treat obstructive sleep apnoea.

Sleep apnoea dental appliances are prescribed by sleep-trained dentists upon referral from a sleep unit.

A dental appliance may also be recommended by the doctor to be used in combination with PAP therapy, when pressures are very high. The idea is for the dental appliance to mechanically open the airway and it is hoped to reduce the PAP pressure required. This is typically for patients with severe obstructive sleep apnoea (OSA). 

Tired of the sleepiness and the snoring?

Then read our free, definitive step-by-step how to stop snoring Guide.

This comprehensive Guide walks you through self-help, signposting, screening, professional assessment and diagnosis, the three categories of prescription treatment, follow-up and rounds off with a substantial FAQ.

Dental appliances for sleep apnoea: an appealing option?

Dental appliances for sleep apnoea may seem a good idea because apart from being far more discreet than PAP (Positive Airway Pressure therapy) what’s that?, there is no need for:

  1. A mask over your face
  2. A pump machine beside the bed
  3. A power supply
  4. A hose connecting you to the pump machine.

But the problem is:

How to know before buying one, if a dental appliance for sleep apnoea, will actually work?

The trouble with a custom-made dental appliance for sleep apnoea, is that you have to wait for it to be made for you.

They’re also:

  Expensive (don’t forget to factor in the dentist’s fees)

  There is no guarantee they will work

  You don’t know if you can even tolerate wearing it in your mouth

 

So, if like me you’re wondering….

Hang on, before I get one, I’d like to know if it works, and if I can wear it!” 

Then keep reading. You’re not alone in wanting to know if they work before they’re used:

The inability to determine BEFOREHAND, who will and who will not find oral appliance therapy effective, has impacted upon wider adoption of dental appliances (by the medical community) for patients with anything other than snoring or mild obstructive sleep apnoea.

So then, you’ll be interested in this brief introduction to the topic of a little known, third category of dental appliance for sleep apnoea.

But first, are dental appliances effective for sleep apnoea?

Can a dental appliance help sleep apnoea?

Yes. Prescription, custom-made, adjustable dental appliances are a valid option for sleep apnoea. They are however, considered second-line therapy (meaning there is a preferred therapy [first-line] i.e. PAP). 

‘Second line’ means that PAP is considered the best option and dental appliances are only considered when a patient fails with PAP therapy.

Can dentists treat sleep apnoea?

A qualified yes:

When a patient has been medically diagnosed and is then referred to a sleep-trained dentist, with a view to the dentist prescribing a custom-made dental appliance.

Such a sleep apnoea patient would require ‘objective titration’. This means that the protrusion (forward movement of the jaw achieved through use of the dental appliance) would be adjusted with reference to data obtained from repeat sleep studies, to ensure the patient’s sleep apnoea was effectively treated.

What is the best treatment for sleep apnoea?

Positive Airway Pressure (PAP) is considered by the medical profession to be the best treatment for sleep apnoea.

However, PAP is an arduous therapy and compliance (those who actually use it) for more than 4 nights a week and more than 4 hours each night are surprisingly few.

Consequently, dental appliances for sleep apnoea, although they may be considered less effective in terms of overcoming sleep apnoea (measured by oxygen desaturation), there is evidence that patients use them more than PAP.

Can dentists diagnose sleep apnoea?

Dentists cannot diagnose obstructive sleep apnoea (OSA). The diagnosis of obstructive sleep apnoea (OSA) is the exclusive preserve of the specialist consultant respiratory physician. 

Uniquely, sleep-trained dentists in the UK may:

  • Screen and recognise obstructive sleep apnoea (OSA) symptoms and refer for further investigation to the GP with a view to a home sleep study.
  • Then in defined circumstances:
    • Provide dental devices without a prior medical diagnosis for those without OSA symptoms

If you’re a dentist interested in training to provide dental appliances for snoring and sleep apnoea patients, then our KnowSleep™ Academy is for you!

How much does a dental appliance for sleep apnoea cost?

  • Some countries in Europe will pay for a dental appliance for a diagnosed sleep apnoea patient.
  • In the UK, this is a grey area. You may be able to obtain an NHS funded dental appliance (don’t expect the best or even a choice) but in my experience, you probably won’t get any help. It’s wrong and it needs to change. A ‘ball park’ price would be anything between ~350 to 1800 GBP for both the dental appliance and dental clinical fees. The price varies for the proximity to London, and of course the sophistication, quality and warranty provided for the dental appliance. Warranties of 5 years plus are available for certain appliances.
  • If you’re in the US and diagnosed with sleep apnea (different spelling) then you should find your dental appliance is a ‘reimbursed therapy’ my advice is to check which dental appliances ARE paid for by Medicare (not all are).

Categories of dental appliance for sleep apnoea

‘One-size fits all’ and custom-made dental appliances comprise two categories of dental appliance for snoring and sleep apnoea:

Category 1: ‘One-Size-Fits-All’

Not a lot positive to say about category 1 dental appliances. Read this if you want to understand more about the ‘interesting’ claims made for them. 

Category 2: Custom-made dental appliances for sleep apnoea

Here are some examples of the 2nd category of dental appliance for sleep apnoea:

The prescription, custom-made, bi-bloc design, dental appliance:

Example dental appliance for sleep apnoea

Figure 1. SomnoWell dental appliance for sleep apnoea. Image used with permission.

Example dental appliance for sleep apnoea

Figure 2: SomnoMed dental appliance for sleep apnoea. Image used with permission from SomnoMed UK Ltd.

How to prescribe oral appliances for snoring and sleep apnoea / apnea
How to stop snoring: The definitive, step-by-step Guide

There is now a 3rd category:

Figure 3, shows the actual predictor prototype ‘in the flesh’ and Figure 2 illustrates where predictor dental appliances fit in the overall taxonomy.

3rd Category of MAD. The predictor / titration MAD

Figure 3:
The Predictor / Titration dental appliance for sleep apnoea
invented by Adrian Zacher MBA.

Taxonomy of dental appliances for sleep apnoea and snoring
Figure 4: Taxonomy of dental appliances for snoring and obstructive sleep apnoea.

Why a 3rd category of dental appliance for sleep apnoea?

Predictor dental appliances for sleep apnoea are not the same as over-the-counter (OTC) anti-snoring devices. OTC anti-snoring devices have been researched (learn how they faired in this definitive guide ↗).

Some years ago (struth it was 2011), I witnessed the competitive emergence of a third category of dental appliance for obstructive sleep apnoea / apnea and snoring:

The Predictor

A Predictor dental appliance is NOT intended to provide long-term therapy. 

Below is short video animation of a prototype sleep apnoea dental appliance (predictor) there is no sound.

Remember, this is an early prototype and it’s NOT intended to be worn for any length of time!

Sleep apnoea dental appliance

Figure 5. CAD prototype of a predictor dental appliance for sleep apnoea and snoring

What questions do predictor dental appliances answer?

The predictor dental appliance finally emerging commercially, interests me as in 2003, I patented new-window (yup, that long ago) a dental appliance with the design intention being to determine: 

1  Can a patient wear a dental appliance? Something that I consider is an underestimated challenge

2  Does it work? 

This second point means both:

  • Subjectively = Partner reported incidence of snoring (during this time the wearer also has the opportunity to adapt to wearing a dental appliance – or perhaps NOT – and the custom-device will of course feel far more discreet)
  • Objectively = In a sleep lab setting the Physician can feel confident ‘signing off’ that the patient will be effectively treated with a dental appliance in the position determined by the Predictor dental appliance

So what? ‘Building the Bridge’

If obstructive sleep apnoea (OSA) patients’ are to be effectively treated the medical and dental profession must work together in a more patient-centric way.

Predictor dental appliances are perhaps the means to ‘build the bridge’ between the two.

The medical professional knows:

1  If the patient responds to mandibular protrusion prior to referral to a dentist for a dentally prescribed custom-made dental appliance

2  That the patient will be effectively treated with a dental appliance, and is ‘prescribing’ a jaw relationship

And the patient knows BEFOREHAND if a dental appliance will work!

I let my patent lapse. This was over 15 years ago! (2003) Damn.

 

Learn more about dental appliances for sleep apnoea:

Download the free bonus below and train at the on-demand KnowSleep™ Academy from Snorer.training:

Download the 'Mouthpiece' Guide as a PDF

Co-author by Adrian Zacher MBA
Co-author Dr Roy Dookun BDS
Peer reviewed by Dr Shouresh Charkhandeh DDS

In this NHS England’s Information Standard accredited Guide, you’ll learn in jargon-decoded language:

  • About the different types of ‘Mouthpiece’
  • How to get one (that actually works)
  • About the possible side-effects

No signup is required.
No credit card.
Nothing at all in fact.
We do this to help – because we can.

Snoring & Obstructive Sleep Apnoea Overview

Meet the co-authors and peer reviewer

Adrian Zacher. Click for full profile [new tab]

Adrian Zacher MBA

Author and Founder of Snorer.com

Dr Roy Dookun BDS, MFGDP (UK), MGDSRCS (Eng), FFGCP (UK), DIP DENT SED

Co-founder and former President British Society of Dental Sleep Medicine

Dr Shouresh Charkhandeh DDS

Award winning Dental Sleep Medicine Dentist

KnowSleep™ Academy: Snoring courses for dentists

Snoring & Obstructive Sleep Apnoea (OSA) – the role of the dentist.

We provide enhanced CPD (continuing education) training courses for dentists and support staff wishing to further their knowledge and understanding about treating patients who snore and/or may have obstructive sleep apnea / apnoea (OSA).

Our on-demand snoring courses for dentists, teach dentists (and GPs) how and when to prescribe custom-made, dental appliances for sleep apnoea and snoring. 

Reviews and Testimonials

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I enjoyed all sections and liked the fact I could complete it at my own pace (fitting it around work and home commitments).

Mary Dentist UK Complete November 25, 2019

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If you think you have a sleep disorder please seek appropriate medical advice.
If you’re in the UK you can get signposted to the most appropriate professional to help you for free. Here.
Created by Adrian Zacher | Page last updated 22nd Mar 2019

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