- KILLER IN YOUR BEDROOM
Estimated reading time: 13 minutes
Within the sleep industry, for as long as I can remember, it’s always been:
CPAP versus Oral Appliances (MAD)
CPAP (Continuous Positive Airway Pressure – the mainstay treatment for obstructive sleep apnoea) had:
Oral appliances (Mandibular Advancement Devices – MADs) were the impudent upstart, and as such were easily dismissed.
Now some 25 years later, both have changed a great deal.
So, where are we today?
I have included a PAP patient’s real life experience in 2020, as a newly diagnosed patient and will balance this with a new patient oral appliance case study when finalised.
This review is structured by examining both options against these five criteria:
Let’s begin with PAP:
Positive Airway Pressure therapy is perhaps more commonly, if incorrectly, known as CPAP.
Where ‘C’ means continuous.
Invented by Professor Colin Sullivan M.B.B.S., PhD, FRACP as recently as 1980, PAP is the default treatment option for Obstructive Sleep Apnoea Syndrome (OSAS).
The market is now dominated by international companies with revenue in the billions of USD.
Today, PAP machines are factory manufactured, in low-cost economies around the world.
Using my five themes, let’s take a deeper look at PAP:
PAP companies service sleep units, which are routinely found in large hospitals. This means that (compared to Oral Appliance businesses) they have relatively few customers to support.
PAP companies have devised ways to establish (and report) how much their therapy is used.
Which is necessary from both a “is the patient treated?” perspective (vital if the patient is in a vigilance critical role e.g. a driver or pilot) and from a reimbursement perspective.
Today, PAP companies are increasingly focused on healthcare data.
It would be a stretch to say their products are merely the means to obtain data and derive financial value, but we are certainly moving that way.
Some healthcare systems (notably the US) only pay for therapy that is used. Which seems entirely reasonable.
Therefore, proof of use is necessary for the company to get paid or ‘reimbursed.’
The medical profession used to view PAP as the only way to treat OSA
You might wonder why?
Medical professionals are human beings, feasibly influenced by a commonly-held belief.
They are also the ‘gatekeeper’ for which therapy is prescribed (meaning they make the treatment choice decisions).
So, while ‘reputation’ may seem vague and empirical at best, it must be considered.
It also has to be said that some PAP companies are, within the industry, perceived as arrogant.
There it is – I’ve said it.
Why is that?
Well, if the only ‘rep’ you speak with is from a PAP company, you are unlikely to become well-informed about other options, including oral appliances.
Remember, dental laboratories are usually regional players who rarely have access to the medical profession.
Of course, this “One Horse Race”, may be at odds with the new patients’ views of PAP therapy. Read about my experience.
Yet, patients can and do get used to PAP so, let’s not paint an entirely black picture.
PAP (when tolerated) is transformative, and over the last 25 years it has developed a great deal.
In my own story, I went into some detail concerning the timeline required for a patient to go from suspected problem to testing to diagnosis to treatment with a PAP machine. It is evident that there is room for improvement in this process.
I was interested to follow a similar timeline of a colleague of mine in the United States. She had been diagnosed with sleep apnea ten years earlier, but didn’t want to wear what she referred to as the “Hannibal Lecter appliance.”
However, two years ago, her younger brother passed away unexpectedly. His only medical ailment was sleep apnea, he had not been using his PAP, and the scene of death pointed unmistakably to sleep apnea.
So, she began to take the issue much more seriously.
Advised to take another sleep study, ten years after the first one, she went through it again and found that this time the results were quite different.
Diagnosed as having only “sleep apnea” the first time around, this time the diagnosis was in her Doctor’s words “extremely severe obstructive sleep apnea.”
There were over 70 interruptions to her sleep due to breathing cessation, oxygenation was in the low 80th percentile, when it should never fall below 95%, and there was substantial limb movement.
All of these symptoms pointed to in her Doctor’s words “an almost emergency case of sleep apnea needing immediate treatment”, so she attempted to follow up quickly.
It took no less than 6 months for her to get all the i’s dotted and the t’s crossed to get the CPAP ordered. Some of this delay was due to the limitations that Medicare places on every case it handles. But much of this she considered was due to just universally poor procedures.
For example, when she wanted to order her appliance and mask, she was told that the company ordered a standard “beginner kit” with an appliance and mask for every customer, and it may or may not fit her needs.
She had reviewed the company’s website in detail and knew exactly what she needed. “Can’t be done,” she was told. “You have to receive the ‘beginner kit’ first, then send it back and tell us what needs to be changed.”
When I asked her what the takeaway was from her overall experience, she emphasised self-advocacy as a prime requirement. “You can’t be shy or polite or passive,” she urged. “Insist on what you need. Even your doctors may not see the importance of backing you up.
They see an idealistic version of how the system ‘should’ work; they don’t really want to be bothered with how it ‘does’ work. So, you have to pick up the slack and make things happen for YOU.”
There is a viewpoint:
PAP therapy just works
Reality has a way of intruding with the need to make PAP usable every night.
Which leads us neatly into compliance:
Compliance with PAP therapy is a contentious topic.
There are many variables, and as many viewpoints, so different outcomes are to be expected.
Stay with me, as we keep to our core themes:
No, I am not likening the PAP therapy hose to an elephant’s trunk… instead I am referring to ‘compliance’ as the taboo, yet extremely obvious topic, fastidiously danced around by PAP advocates.
Specifically, if compliance isn’t very good – is PAP an effective therapy?
Here’s an analogy for you:
If I kicked you out of bed after 4 hours sleep, would you consider that sufficient rest?
No. Neither would I.
This peculiar parameter (4 hours sleep) is the historic low-bar set, for a patient to be considered compliant (satisfactorily using) PAP therapy.
Cleverly, it does not matter where the compliance line is drawn, if you are comparing something with nothing.
‘Something’ being objective evidence that PAP is used.
‘Nothing’ being merely subjective patient reports of use. (Technical difficulties and costs have so far prevented most oral appliance companies from routinely providing objective compliance data – the mouth is a hostile environment).
Then the argument morphs into:
PAP therapy is evidenced to have been worn 4hrs a night (even if not used every night) and is considered 100% effective when used.
Oral appliance therapy, ‘claimed’ by the patient to have been worn 7hrs a night, every night if perhaps less effective?
In a study of mild to moderate OSA patients, Barnes et al1 found that:
“both CPAP and mandibular advancement splint effectively treated sleep-disordered breathing and sleepiness” [and that this] “may be due to the splint having a lesser therapeutic effect and CPAP being poorly tolerated and therefore used less in this patient group”.
Now let’s compare the supporting evidence for each therapy option.
I am referring to clinical research evidence.
In terms of years, it may be surprising to learn that despite oral appliance therapy having been around for a century (we’ll get to that shortly), it lags behind PAP.
PAP now has a substantial and frankly superior body of evidence to support its use.
PAP has long been the de facto King: the ‘only’ therapy for OSA.
As such, the money flowed and research (which costs a great deal) has largely established for whom PAP works – and for whom it doesn’t2.
‘First line’ simply means the default or ‘no brainer’ option.
As a patient, if you can’t (or won’t) get on with PAP, then for a long time you had no other option.
YOU were the problem.
Today, oral appliances are at least thought of as a second-line option for OSA (the next best thing) even if oral appliances are not reimbursed (meaning you have to put your hand in your pocket).
“Don’t make me think…”
was something I was taught at business school. If you can take away the need for the customer to think, then you’re on to a winner.
Which is exactly what PAP companies have achieved.
Let’s explore this a little deeper:
From the medical professionals’ perspective, this is where PAP annihilates oral appliance therapy.
There is no need to think about it.
Nobody, ever lost their job for prescribing PAP.
PAP companies and distributors have big budgets and dedicated support staff.
All of which removes the need for thought.
It is easy for a sleep unit to set the patient up on PAP and send the patient home the same day they’re diagnosed.
The patient has their treatment device ‘immediately’.
PAP is an inventory item; they don’t need to refer to anybody else, or wait for it to be made.
PAP therapy will overcome apnoea. If it is worn it can be considered effective.
Regrettably, the same cannot be said for oral appliances.
Oral appliance therapy for sleep-related breathing disorders, can trace its origin back to 1923.
When a French dental surgeon, Pierre Robin3, discovered that physical irregularities of the airway, lead to breathing difficulties during sleep.
Prescription oral appliances are manufactured by trained and registered dental technicians.
Each oral appliance is custom-made for the patient.
The fee the patient pays (no room to go into occasional reimbursement here) consists of:
Consequently, the dentist may increase their profit margin by shopping around for a cheaper dental laboratory.
This perfectly understandable attitude makes for a cut-throat dental laboratory business where corners may be cut to save pennies… #justsaying
Dental laboratories typically serve hundreds of dentists. Who each in turn prescribe perhaps one oral appliance a year.
The lab must support and guide them, and then invoice and follow-up for payment.
Consequently, the administrative cost per patient is higher for a dental laboratory than a PAP manufacturer.
Unlike PAP companies, oral appliances typically do not have objective usage data.
Some oral appliances have used temperature monitoring technology borrowed from the frozen food transportation industry (monitoring temperature over time).
However, this is adds a cost and is even then not fool proof.
This effectively excludes them from healthcare systems that reimburse based on usage/compliance data.
Prescription oral appliances are custom-made exclusively for you. Typically a large element of the construction process is ‘by hand’. Those hands belong to highly skilled dental technicians. (I know – I used to be one!)
There is a finite capacity with custom manufacture. As in 1 technician can make X devices per week. This plays into the volume and margin calculation.
For PAP you just buy another bigger, faster machine. Because you’ve already moved production to low-cost economies…
Oral appliances (with their absence of objective patient usage data) have struggled to gain access to healthcare systems.
This is a story of multiple ‘Davids’ (the dental labs) per country and a few global ‘Goliaths’ (the PAP manufacturers).
Should they have the vision to do so, regional dental laboratories are unlikely to be able to afford a ‘rep’ to visit sleep units.
That is if they’re not met with:
All of this is assuming dental laboratories are not met with “Who?” when they try to get in front of the medics (the ‘gatekeepers’).
The few larger national or international oral appliance manufacturers, are now actively building their (and their product) reputations in sleep units and where Covid19 permits at exhibitions etc.
From a standing start.
Some Countries now provide reimbursement otherwise its an ‘out of pocket’ expense – you pay and you’re unlikely to get an insurer to help.
Undeniably oral appliances cost more than PAP per patient.
So, it’s a reasonable question to ask:
Let’s break down the typical cost to the patient, of a prescription oral appliance.
It’s consists of two main things:
Device fees ranging from ~ £150 – £1100 GBP ($170-$1250 USD)
Dental clinical fees (not so easy to quantify)
Assume an oral appliance lab fee (to the dentist) of £150. Which if we use our ‘rule of thumb’ makes the clinical fee £450.
Therefore your total is £600 GBP or thereabouts.
This assumes no prior dental work is necessary to get your mouth up to scratch and that current X-rays are available.
It’s also important to remember that unless you’re diagnosed with sleep apnoea, oral appliances for snoring are considered by HMRC to be luxury items, and therefore the oral appliance fee from the lab, attracts 20% VAT. #InsultToInjury
When the patient has been medically diagnosed, the most appropriate treatment option is considered by the sleep physician.
There are many factors to consider and there is no getting away from it, sleep physicians may be reluctant to refer a sleep apnoea patient to a dentist.
Some of their typical reasons include:
Sleep-trained dentists are still few in number and there may be an absence or lack of choice of dentist (geography plays a role here).
Starting to get the picture behind their combative attitudes?
So, let’s meet the combatants:
Rivalry between professions is a fact of life. Advancement of patient care comes second place.
Cynical or pragmatic?
The availability of self-fit, non-custom oral appliances (with their inherent limitations) undeniably tarnishes the reputation and undermines the concept, of oral appliance therapy as a whole.
If you’re a regular of snorer.com you’ll know my viewpoint:
I consider these gadgets trivialise snoring, exploit the naive, and merely delay.
Clinical research continues to find patients prefer oral appliances to PAP.
The chart below presents oral appliances versus positive airway pressure (and to extent surgery).
(Aerophagia means air in your stomach – sometimes a side-effect of PAP therapy).
Click on the image to expand it (X top right to close).
The American Academy of Sleep Medicine recognise that patients may prefer oral appliances5 although PAP is first-line therapy for mild, moderate and severe OSA.
Currently, it’s difficult to determine who will respond to oral appliance therapy.
A ‘theragnostic’ approach (try it and see) is something I pioneered and is being pursued by Zephyr Sleep Technologies.
Without theragnostic tech it’s feasible that the oral appliance:
Add it all up and it is a barrier when paid for ‘out of pocket’.
The lack of proof of compliance goes someway to explain their reluctance to refer to a dentist:
What do you mean you don’t have any proof?
In reality zero data exists to verify that an oral appliance has been worn – yet this is required in the US for Durable Medical Equipment (DME) suppliers to get paid.
And increasingly the rest of the world is going this way.
When oral appliances can routinely and reliably provide compliance data, (has the patient worn the device) then a major barrier to their adoption, will have been overcome.
Tired of the sleepiness and the snoring?
Then read our free, definitive step-by-step how to stop snoring Guide.
We’re back to money again…
Despite oral appliance therapy for sleep apnoea having been around for a long time, as a medically researched concept, very little happened until the 1990s.
What’s gone wrong?
Clinical research costs money. Oral appliance companies typically do not have the budget for research.
Yes, research funds are available but these are typically accessed by medics (read the next toggle box).
Multi-disciplinary research teams are regrettably unusual.
Clinical trials of oral appliances carried out by medical professionals have led to some regrettable waste of time, money and opportunity.
Where oral appliance companies have been able to progress clinical research, they were keen for the research to prove superiority of their oral appliance.
While understandable, it risks further dilution of the supporting body of evidence.
A long and convoluted route is required (where it exists) to set up an OSA patient with oral appliance therapy.
Click on an image to expand it (X top right to close).
Now compare that with PAP below:
Someone once said:
“Money makes money”
and it’s fair to say PAP companies have the upper hand here. They have a lot more money than oral appliance companies.
While some PAP companies are perceived as arrogant. People in these organisations change, and we can hope the culture of these companies will do so as well.
Oral appliance companies are now gaining access to some more progressive medical ‘gatekeepers’.
Both oral appliances and PAP take time to get used to. Oral appliances may also experience a longer titration period before snoring/OSA symptoms may resolve.
Great strides have been made by the PAP companies, with significant improvements in mask design and algorithms to make PAP easier to tolerate.
While PAP has a larger body of evidence than oral appliances, both have an unarguable role in the management of sleep-related breathing disorders.
Access to oral appliance therapy remains difficult and slow.
The continued disconnect between medical and dental professionals fails the patient and does not reflect well upon either party.
The good news is that a ‘What is best for the patient?’ approach continues to develop, because healthcare professionals care.
They juggle the practicalities, indications, and contra-indications of each option – every day.
Yet the ongoing risk remains
The commercial combatants in their struggle for market share, forget what they are here for:
A vigilance critical patient needs to be medically ‘signed off’ as fit to return to work.
Imagine YOU are the sleep doctor who has to certify that the patient (let’s say they’re a commercial airline pilot) is compliant with a therapy that:
Now I ask you, how comfortable do you feel certifying they are fit to hold a licence? Would you want to be a passenger in their aircraft flying long-haul?
No. Neither would I.
As you can see, it is not a simple choice and there is no clear ‘winner’.
The only conclusion to draw is:
What is best for the patient?
The sleep doctor, who has your medical history, your sleep study results, and knowledge of your occupation and lifestyle, balances all of this when they make a diagnosis and write your prescription.
Maybe you’re wondering about the options?
The thing to do is to communicate with the healthcare professionals who are caring for you.
Be guided. Sleep well.