Interesting Study on an Israeli Oral Mask

[49er]

Compliance with CPAP is the major limiting factor in treating patients with OSA. The novel SomnuSeal mask is an oral self-adaptable mask located between the teeth and the lips ensuring that there are no air leaks or skin abrasions. Fifty patients with , who failed previous CPAP trials, were asked to sleep with the mask for one month. In all patients, the mask was connected to an AutoPAP machine with a heated humidifier. Efficacy, convenience, and compliance (average usage for 4 or more hours per night) were monitored. Fifty patients (41 m and 9 f, mean age years, BMI  kg/m2, and AHI /h) participated. Eleven were classified as compliant (average mask usage of 26 nights, 4.7 hours per night), five were only partially compliant (average usage of 13 nights, 2.9 hours per night), and 34 could not comply with it. In all patients who slept with it, the efficacy (assessed by residual AHI derived from the CPAP device) was good with an AHI of less than 8/hour. Interestingly, the required optimal pressure decreased from an average of 9.3 cmH2O to 4.6 cmH2O. The SomnuSeal oral interface is effective and may result in converting noncompliant untreated patients with OSA into well-treated ones.

Read the rest at this link:

http://www.hindawi.com/journals/sd/2013/840723/

By the way, I was trying to figure out how this would be better than the oracle mask such as wondering if nasal plugs were needed. Couldn't tell from the article.

Looks like a fascinating study. With compliance so low, more of these studies are definitely needed.

49er

[Sleep2Die4]

With compliance so low, more of these studies are definitely needed.

WT? Don't you have that exactly backwards?

With compliance this low,

Eleven of 50 were classified as compliant (average mask usage of 26 nights, 4.7 hours per night)

why waste time and money on another study?

[Pugsy]

I had the same initial knee jerk reaction regarding 11 people being able to make it work but I then read the study results again and they used 50 people who had NOT been able to tolerate cpap at all prior to trying the oral mask. I initially just thought 50 cpap users to start with and that's not the case...they picked 50 cpap failures to use.
Of course we don't know why they failed and probably not all failed because of mask issues.
I thinking picking up another 20% of those who fall through the cracks and would fail otherwise is pretty good myself.

I don't really care for the AHI of 8 benchmark personally but we are used to shooting for much, much lower numbers here in the US but an AHI of 8 might be a spectacular result for someone who untreated has an AHI of more than 30...
Some therapy is better than no therapy. We tend to think that therapy is a total failure if the AHI isn't well down below 5.0 but that's really not the case. It might not be optimal therapy but it still isn't a total failure if the AHI isn't quite what we want.
Hey, what if their untreated AHI was 80 plus...?? I would take 8 AHI from someone who couldn't/wouldn't otherwise use the cpap machine any day of the week. I would rather see that than "I can't get my AHI down to whatever magical number someone wants and I can't use the mask so it isn't helping and I quit".

[49er]

Sleep2Die for,

Sorry to offend you but many researchers, including the Australian Scientist, who has discovered that sleep apnea may have other causes, has made this same comment. Finding the right mask is a big time factor with compliance so I am not sure why you would find the remark surprising. If I am misunderstanding your point, my apologies.

By the way, the CEO of Discover Medical Service, Eran Levi, responded every promptly to an email I sent about buying this mask. Unfortunately, sales haven't started and I had the sense that he didn't have a time frame.

49er

[BlackSpinner]

With compliance so low, more of these studies are definitely needed.

WT? Don't you have that exactly backwards?

With compliance this low,

Eleven of 50 were classified as compliant (average mask usage of 26 nights, 4.7 hours per night)

why waste time and money on another study?

Because they have to know what doesn't work as well as what does. In fact it is sometimes more important.

[JDS74]

I, too, have inquired about availability but no answer yet.
As soon as they become available, I'll get one to try.
It's always good to have a second source.
Patent issues for this mask will be interesting.

[Pugsy]

According to their Facebook page it is not suitable for pressures over 6 cm.
https://www.facebook.com/pages/Discover ... 1699498587

It wouldn't work for me as I am someone who has to use their nose and like the Oracle oral mask...the nose has to be not used and that would be a big problem for me even if 6 cm would adequately hold my airway open (remember I sometimes need upwards of 20 cm to keep my airway open).

Still yet...some therapy is better than no therapy if traditional masks and pressures are total failures and the machine is sitting in the closet.

[49er]

I, too, have inquired about availability but no answer yet.
As soon as they become available, I'll get one to try.
It's always good to have a second source.
Patent issues for this mask will be interesting.

Hi JDS74,

Mr Lavi told me it would be another year before it was ready for sale. Unfortunately, I forgot to ask him why and have already sent too many "forgot to ask" emails.

Pugsy, he did say it would not require nasal prongs.

And I just received an email from him stating it would work at all pressures.

49er

[Pugsy]

How do we prevent the air from going up the airway and trying to exit out the nose?
I saw there was no mention as to nasal prongs/clips or cotton balls stuffed up the nose but I am wondering how it works if nose is left alone.
Maybe that is just part of making it an acceptable alternative to the other failed attempts. Some nose leakage would still be better than no therapy at all.
Similar to how I feel about my sometimes mouth leakage...maybe it isn't so much that it is a horrible impact on therapy.

I think it looks interesting and if I didn't have to stuff cotton balls up my nose or similar contraption...you know me..when it looks interesting then I am willing to give it a try.
Maybe I should revisit the idea of the Oracle... and just say to heck with worrying about the nose and see just what happens.

Too bad it is a year away from mass distribution...wonder if Avi123 still has some contacts in Israel that might be able to get their hands on it???

I am a bit afraid that my mouth opening might cause me to let the darn thing just fall totally out but maybe my mouth won't open that much. Most of the time when I have woke up to some mouth breathing my lips are barely parted and I can't even see it on the reports.

Anyone have an unwanted Oracle hiding in the mask drawer???

[49er]

Good question about the nose leakage issue. I seriously doubt too much would leak from my nasal passages but obviously, everyone is different.

49er

How do we prevent the air from going up the airway and trying to exit out the nose?
I saw there was no mention as to nasal prongs/clips or cotton balls stuffed up the nose but I am wondering how it works if nose is left alone.
Maybe that is just part of making it an acceptable alternative to the other failed attempts. Some nose leakage would still be better than no therapy at all.
Similar to how I feel about my sometimes mouth leakage...maybe it isn't so much that it is a horrible impact on therapy.

I think it looks interesting and if I didn't have to stuff cotton balls up my nose or similar contraption...you know me..when it looks interesting then I am willing to give it a try.
Maybe I should revisit the idea of the Oracle... and just say to heck with worrying about the nose and see just what happens.

Too bad it is a year away from mass distribution...wonder if Avi123 still has some contacts in Israel that might be able to get their hands on it???

I am a bit afraid that my mouth opening might cause me to let the darn thing just fall totally out but maybe my mouth won't open that much. Most of the time when I have woke up to some mouth breathing my lips are barely parted and I can't even see it on the reports.

[ems]

Again... where in the world is Avi123? Or Matt Lauer?

[chunkyfrog]

Any publicity about alternative mask styles is a good thing. We need it for a lot more masks/machines.
Considering all the drop-outs who could be tempted to try something different, it warms my heart.
I'd like to see Mike (on Mike and Molly) trying a Sleepweaver (any model).
It appears the writers have him dropping out, silently.
Does anyone ever tell people, "Hey guys, I'm going to stop this lifesaving therapy because (insert lame excuse)."

[Hang Fire]

Incredible that there are humans who could sleep with that in their mouth. Must be terribly sleep deprived.

[JDS74]

Hi Pugsy,

With the Oracle 2 mask you can learn to not exhale though your nose just like folks who use nasal masks can learn to not mouth breath.

At least that is true for some. I have recently started using a soft cervical collar which has eliminated mouth drop and the leaks I used to get that way.

While it is better to have some sort of nasal mask because of humidity issues, I keep trying to let people who can't use that type of mask know a workable alternative mask exists. If this new mask comes to market, it will be another way for folks who weren't able to be compliant to try a different mask that might work for them.

[zoocrewphoto]

I, too, have inquired about availability but no answer yet.
As soon as they become available, I'll get one to try.
It's always good to have a second source.
Patent issues for this mask will be interesting.

I tried to get photos as the only problem I have with the oracle is that it holds my jaw open further than I like. I didn't find a photo, but it did say it can't exceed a pressure of 6. Since most people feel suffocated at 4 and 5, it has some rather limited usage. My pressure is 11-17.