CPAP mask evidence

Finding CPAPtalk forum has been a lift. I'm approaching two months of therapy and its been a struggle. I appreciate the support in both the private messages and the experience shared in the forum threads. Participating in these forums has a learning curve attached. For instance the word "brick" has a new meaning!

In my day job I teach evidence based practice, so today I spent some time looking at evidence related to CPAP. Much of the high quality evidence investigates the efficacy of CPAPs ability to positively impact physiological factors. The probability of positive cause and effect is quite high. This is good. The therapy is effective. But then there are statements about the problem of compliance, due to discomfort, that diminishes the efficacy of the therapy. This led me to browse through the evidence related to CPAP comfort factors. The two comfort factors that were repeatedly mentioned were related to air flow and masks. Much of the best available evidence about CPAP comfort is related to characteristics of the air flow/pressure. There appears to be a growing understanding of the subtleties of delivering air pressure in an effective and comfortable manner. This seems to be reflected in the engineering of new CPAP machines.

But evidence related to mask design was quite different. I could not find qualitative evidence investigating the CPAP mask priorities of users. I did not find descriptive studies defining the range of mask needs/priorities of CPAP users. Nor did I find exploratory studies investigating efficacy of protocols for guiding CPAP users to identify masks that meet their unique comfort needs. I don't want to suggest that I did a systematic review of the literature but I did dig pretty deep and I'm surprised by the paucity of what I found related to mask comfort. Am I missing something? Is this type of research being done on a proprietary basis and not listed in the major medical databases?

I have been compliant for 15 years but I really wonder how?

I live in Ontario Canada, and my situation is different than it is for most US participants.


Here is what I think I've learned.
When everything is working, cpap is wonderful. I feel genuinely better.
When things start going poorly, then I don't respond well. I carry on regardless. (I have been encouraged to believe (sleep doc.) that my machine tells him that I wear the mask, with the machine turned on.) Reality is that there is a lot more to cpap therapy! And the reality is that I find people here that take control of their treatment, and respond very quickly and very well and do much bettr than I.

In my cpap world, I need a prescription from him to get a machine. He will authorize cpap--constant pressure.
I need a prescription from him to change pressure. And that needs to be done by my equipment supplier.

So, the reality is that I have much to learn.

It seems to me that success comes from having a good sleep Doctor. (I don't.) And a good equipment supplier (I may now) who can simplify your search for machines, masks, and accessories. The supplier can download your history (if your machine, like mine, will do this.) And this download will show if you are successful in your treatment.

So this forum has made a real difference for me. Effectively I have a network, and some hope.

cpap.com appears to me to be an enlightened supplier. They publish an review of their sales monthly. They sell an incredible amount of equipment. Going to that review you can see what others have bought. The actual percentage of mask types. The actual percentage of mask models. And changes from other months, allowing me to guess whether equipment listed is more or less popular. I find the analysis very helpful. https://www.cpap.com/cpap-user-preference.php will allow you to request this report weekly or monthly.

Does this help? I find it hard, hard work to be compliant. I would like to have completely different equipment than I have, and multiple masks. I would also like a new sleep Doc.

Best,
DaveL
Toronto

I know more people that are non-compliant than that are compliant. Everyone that quits has a reason...I tell them it's not easy, but it's worth it.be compliant.

There are many, many questions. There are many answers here.

Mask leaks? There are often fixes. And there are other masks.
Mouth breathing? Other masks may work better. There are fixes here too.
CPAP comfort? There are accessories...pillows for instance. different headgear. lovely pads to prevent mask-strap marks. Devices to support your hose, so it doesn't tug your mask off your face.

Suggest you ask questions here, and others more knowledgable than I will provide you with answers. There are many caring people here. And I *think* treatment is not a science; it's an art. The most important communication tool is listening.

DaveL

eeckel wrote: Am I missing something? Is this type of research being done on a proprietary basis and not listed in the major medical databases?

I have not seen anyone here on cpaptalk reference any medical reviews regarding mask comfort and its effect on CPAP compliance. Mostly it is anecdotal. I used a Nasal Mask during my split study. It worked pretty well there. I was given the same mask to take home. It was not fitted very well, and I had issues (first, too tight, second, too many leaks). I finally got it under control, but was still bothered by the plastic resting on my forehead, and the chunk of plastic between my forehead and the mask that would prevent wearing glasses, but contributed to the feeling of "too much stuff on my face."

If it wasn't for this forum, I don't think I would have heard of nasal pillows, which I switched to after 30 days, and now, after my second 30 days, find really to work well for me.

John

eeckel wrote: But evidence related to mask design was quite different. I could not find qualitative evidence investigating the CPAP mask priorities of users. I did not find descriptive studies defining the range of mask needs/priorities of CPAP users. Nor did I find exploratory studies investigating efficacy of protocols for guiding CPAP users to identify masks that meet their unique comfort needs. I don't want to suggest that I did a systematic review of the literature but I did dig pretty deep and I'm surprised by the paucity of what I found related to mask comfort. Am I missing something? Is this type of research being done on a proprietary basis and not listed in the major medical databases?

I believe you are looking for a scientific answer to a marketing problem. That is, the researchers are not attempting to identify the mask needs of CPAP users comprehensively. Instead, the manufacturers are trying to gain market share. To do this, they would identify a market segment that is choosing competitors' products, and design a new product for them that is preferable to what they are currently using.

I'm not sure there will BE studies on them because it's not a treatment parameter. Masks are merely a delivery mechanism for the treatment.

As long as your mask "works", then the prescribed treatment gets there.

The good news, if you want to think of it that way, is that with many more people being diagnosed with sleep apnea, there's a larger market for masks and other CPAP gear which is getting manufacturers to offer more options. Manufacturers are also getting smarter about what they're designing.

eeckel wrote:In my day job I teach evidence based practice...

So, what do you teach about gathering and analysing evidence in situations where there are a very high number of concurrent variables, including human factor responses which are often not rational by any reasonable measure

Cheers,

Bill

The two big factors with masks are comfort and presence or absence of leaks, often at odds with each other and just as often different every night, at least within a small range, with a general consensus about what's acceptable both to the person wearing the mask (whichever one it is), and to the machine's measurement of results. It isn't as if there are just two masks on the market that consistently behave in certain ways relative to each other... I would imagine that the large number of them, worn by anatomically different individuals who sleep in so many different positions, never mind the small changes each makes throughout a night, often in less than adequately fitted sizes and shapes make it extremely difficult to calculate any fine points with consistency.

Julie wrote:The two big factors with masks are comfort and presence or absence of leaks, often at odds with each other and just as often different every night, at least within a small range, with a general consensus about what's acceptable both to the person wearing the mask (whichever one it is), and to the machine's measurement of results. It isn't as if there are just two masks on the market that consistently behave in certain ways relative to each other... I would imagine that the large number of them, worn by anatomically different individuals who sleep in so many different positions, never mind the small changes each makes throughout a night, often in less than adequately fitted sizes and shapes make it extremely difficult to calculate any fine points with consistency.

very nicely said, Julie.
or for we engineers, X variables and 2X unknowns makes is hard to isolate a solution set. We need a "Mission Impossible" toolkit to make custom flexible masks at an acceptable cost; then maybe mask effectiveness would improve. As it is now, it's a trial and error process with limited help along the way.

Ready-to wear masks or cushions do NOT fit everyone.
The closest exceptions are the cloth masks, since the soft, air-resistant fabric has more flexibility
than gel or even just silicone. I remember computerized custom jeans;
but imagine having a custom made sloper for your own tailored cloth masks!
Even infants and children could enjoy them, as well as anyone with massive facial injury or deformity.
God loves us all.

Am I missing something? Is this type of research being done on a proprietary basis and not listed in the major medical databases?

I'm quite certain that mask manufacturers must be doing this type of research. ResMed in particular seems to bring out a lot of new models, and some very real improvements to some of their masks--I'm sure it doesn't come out of thin air. And I would guess that you're correct that it's proprietary.

The disconnect occurs "in the field" so to speak. Doctors rarely concern themselves with the minutiae of masks and offer little support to their patients in that regard. The DME's do the initial fittings, adjustments, and replacements, so a good DME can really help support a newbie or be of absolutely no help at all. And whether they connect to the manufacturers about what works and what does not is anybody's guess. Clearly they are choosing stock, so there's some informal "research" to be had from what is ordered most frequently. Nobody seems to contact us, the end users, for research purposes.

Another link is that the sleep lab techs have their own "science" for choosing masks to be used during sleep studies. Whether there's anything in their publications I don't know. You might try asking on the sleep lab professionals website: http://www.binarysleep.com/phpbb2/index.php?c=10 ( NOTE: They are not to happy with us posting on their site, just as we don't really appreciate it when they post on ours).

Since mask fit is no doubt a proprietary matter, it is unlikely that patient contact would be public,
if there is any at all. We can hope that the companies are using real apnea sufferers for subjects,
not random pretty faces, although my experience with many masks leads me to believe that
may not be too far from the truth.
In summary, if you are not in possession of a 'normal' face, you are pretty much screwed.

eeckel wrote:Finding CPAPtalk forum has been a lift. I'm approaching two months of therapy and its been a struggle. I appreciate the support in both the private messages and the experience shared in the forum threads. Participating in these forums has a learning curve attached. For instance the word "brick" has a new meaning!

In my day job I teach evidence based practice, so today I spent some time looking at evidence related to CPAP. Much of the high quality evidence investigates the efficacy of CPAPs ability to positively impact physiological factors. The probability of positive cause and effect is quite high. This is good. The therapy is effective. But then there are statements about the problem of compliance, due to discomfort, that diminishes the efficacy of the therapy. This led me to browse through the evidence related to CPAP comfort factors. The two comfort factors that were repeatedly mentioned were related to air flow and masks. Much of the best available evidence about CPAP comfort is related to characteristics of the air flow/pressure. There appears to be a growing understanding of the subtleties of delivering air pressure in an effective and comfortable manner. This seems to be reflected in the engineering of new CPAP machines.

But evidence related to mask design was quite different. I could not find qualitative evidence investigating the CPAP mask priorities of users. I did not find descriptive studies defining the range of mask needs/priorities of CPAP users. Nor did I find exploratory studies investigating efficacy of protocols for guiding CPAP users to identify masks that meet their unique comfort needs. I don't want to suggest that I did a systematic review of the literature but I did dig pretty deep and I'm surprised by the paucity of what I found related to mask comfort. Am I missing something? Is this type of research being done on a proprietary basis and not listed in the major medical databases?

Because the issue of fit and comfort is so subjective I doubt that any studies would be done by any entities other than the device manufacturers themselves who could afford such endeavors. Although I have yet to see any advertisements claiming "9 out of 10 cpap users prefer X brand face masks in blind tests....." If any clinical, academic studies do exist please let us know.

The manufacturers must know what works and what fits the majority of patients -- based on initial design studies and certainly by the numbers of sales and mask returns. And the designs are slowly changing, like the new Amara and Pilario. Alas, for users, the new designs seem to be coming out at a glacial pace and many existing designs leave much to be desired.

I suspect this is sort of a blind spot in our medical research field.

Experiments tend to be based on the patient doing what the experimenter says. "Shut up, put on THIS particular mask, this CPAP machine, this treatment protocol." If it doesn't work, we simply lump you in the "failed" category.

Too many doctors tend to think the same way.

Choices of mask type are probably less interesting to "serious" researchers working in the public interest. Manufacturers might do some research, but of course, they're not likely to share their results with their competitors. They're also unlikely to publish anything that hurts their own sales.

So when I first met my 2nd sleep doc (my current sleep doc, almost 10 years later) he advised me to keep it simple.

I had used a Breeze nasal pillows mask for about 4 years...with lots of leaks, and poor sleep habits. I bought a nasal mask (trying to keep him happy; funny, I've never seen him happy.)

I've used a nasal mask ever since. Lately, some regrets. I wish I had a good full face mask now. Perhaps soon....

I think there's no science to it with my equipment supplier. It's like the bowls of porridge in the children's fable. So I continue muddling on.

Meantime, I wonder whether the posts have helped the original poster. I *think* I have finally found a good equipment supplier. I *hope* to replace my sleep doc soon...

DaveL
Toronto