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Oral Sleep Apnea Appliances--How Effective Are They For Severe OSA?

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SleepDent +0 points · over 2 years ago Original Poster Sleep Commentator

O.K.. You have severe sleep apnea. You have given CPAP your best shot. Used every mask on the face of the earth. Tried several machines. Been coached by the best sleep staff. Just can't do it. Where do you go from here? Well, using the CPAP standard for efficacy, oral appliances have been rated at about 30% successful. Not very promising. Is that the end of the story? I think not. Here is a practical guide to turn failure into success: 1. Optimize your nasal patency(ability to breath through your nose). See an ENT for a complete evaluation. Control that chronic sinusitis. Control that allergic rhinitis. Consider turbinate reductions and septoplasty, if indicated. Good nasal patency can significantly improve the success rates for oral appliance therapy. 2. Don't let the perfect become the enemy of the good. Currently, there is no consensus among the dental sleep medicine community on what efficacy standard should be applied to oral sleep apnea appliances. There are several standards in wide usage. Let's consider the LEAST stringent standard. This states that an oral appliance is successful if it reduces the AHI at least 50% to an AHI below 20 with a total abolition of symptoms. Using this less stringent standard, a well-regarded study by Dr. Hoekema shows a success rate of 69% in treating severe OSA. In all fairness, this study used ideal conditions and would probably not be realistic for normal clinical practice, so maybe the success rate would be 55-60% in the real world. What does that get you? Well, you would sleep well at night and you would feel alert during the day. In terms of medical outcomes, it is unclear if getting the AHI slightly under twenty would be sufficient to take heart attack, stroke, and increased mortality off the table. It might or it might not. Not a settled issue. 3. Consider combination therapy. People who are CPAP intolerant but for whom oral appliances can not control the OSA adequately, can often find success by combining the two. Most notably, there is the Tap-Pap CS system. This combines a TAP OSA appliance with nasal pillows. The oral appliance lowers the necessary CPAP pressure at least marginally and sometimes substantially. The device is secured by the teeth and there are no external straps. Mask leakage is nil and mouth leakage can be controlled by an intraoral mouth shield. Works pretty well in terms of comfort and acceptability. But the most exciting fact is that the combination device is MORE powerful than CPAP alone. The treatment AHI is usually as good as CPAP or BETTER! Good luck and a restful night's sleep to you. Arthur B. Luisi, Jr. D.M.D. The Naples Center for Dental Sleep Medicine. Practice partner, dental sleep medicine, NCH Healthcare system. Practice partner, dental sleep medicine, The Millenium Physician Group.

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BGailDemko140 +0 points · over 2 years ago

Hoekema's study was also short term and, therefore, he did not have to contend with aging and weight gain in the subjects. Also, he used a TAP 1 and this data cannot be extrapolated to be the same with all TAP appliances unless a comparison study is done showing that the outcomes of studies done with a TAP 1 are the same as outcomes with , say, a Dream TAP..

Combination therapy is a boon to many people. In Ron Prehn's article 2017 in JDSM, (open access) he treated 220 patients with combination therapy. Of those who received TAP-PAP CS, 27 % failed, but were successful with a custom face mask - one made to fit each patient, made from a customized mold of . https://aadsm.org/docs/JDSM.04.02.pdf There is always an option. Keep looking.

B. Gail Demko, DMD

Sleep Dentist Consultant to MyApnea.Org

Assoc. Editor of the Journal of Dental Sleep Medicine

Expert Advisor to the FDA on Oral appliance Therapy

Past President of the Academy of Dental Sleep Medicine

American Board of Dental Sleep Medicine

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SleepDent +0 points · over 2 years ago Original Poster Sleep Commentator

Interestingly enough, I played a small part in the development of the Tap-Pap CS, and, as such, can shed additional light on the subject. When I was doing some initial testing on the Tap-Pap CS, I experienced the same problem reported by Dr. Prehn, i.e., a significant failure rate of the Tap-Pap CS due to leakage through the mouth. Actually, this was to be expected, because, like any mask employing a nasal mask with an unsealed mouth, a fair proportion of patients will mouth breathe enough to break down the system. I reported the problem to Airway Management and they are aware of it. However, I am quite proud that I actually found a fix for the problem. As you may know, the MyTap comes with an optional intra-oral mouth shield. I discovered that this mouth shield can slide over the metal column on the Tap-Pap CS, that it creates a perfect intra-oral mouth seal, and turns the Tap-Pap CS from a nasal mask to a full face mask equivalent to the custom mask described in the article. If Dr Prehn had tested the Tap-Pap CS thus equipped, the failures would have been eliminated. However, it is not available commercially configured this way right now and Dr. Prehn would not have been aware of the fix, as I am. This is potentially very important, as most dentists attempting dental sleep medicine would not have the skill or inclination to deal with making custom face masks. I personally use the Tap-Pap CS as a full face mask with great success, but nobody else knows to do it yet. I hope that this helps you. Arthur B. Luisi, Jr., D.M.D., The Naples Center for Dental Sleep Medicine. Practice Partner, dental sleep medicine. NCH Healthcare System. Practice Partner, dental sleep medicine, Millenium Physician Group.

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SleepDent +0 points · over 2 years ago Original Poster Sleep Commentator

I made further inquiries and was informed that this modification, regardless of its merits can not be accomplished without further regulatory approval from the F.D.A. . We are going to see if we can take some parts that have been previously approved by the F.D.A. and use them. If it is not possible, there will be considerable delay to gain approval. Will keep you informed. Dr. Luisi

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