Expert advisor to the FDA in oral appliance's (OA) for sleep apnea
Associate Editor of the Journal of Dental Sleep Medicine
30 years of OA experience
30 years of OA experience
The AADSM has a website for dentists who are interested in oral appliance therapy for sleep apnea. In Louisiana , there is one member, but you may be close enough to state lines to go to another. AADSM.org.
Having a dentist say you should use multiple therapies though often required; I think that the Sleep MD should be the one to make that call. Since you have seen an ENT before, also go see the ENT and ask him what he thinks.
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
Todd is an old friend. I have worked with him on boards and committees for decades. I'll ask him in Baltimore next week. Thanks
The PDAC list is available at:
Or, from any search engine, type in 'PDAC'- click
You will come to a page with the name 'Noridian' on the left. Noridian sets the guidelines for ALL DME items for CMS (Medicare)
Below the name 'Noridian,' on the left, is a list of topics. The first is 'home' but the second is 'Search for DMECS for Codes and fees'.
Click on this line.
Next will come a series of boxes. The last on the left is : Search DMEPOS Product Classification List - double click this box.
Up will come " Search DMEPOS Product Classification List with boxes to fill in.
In the box : HCPCS Code. Type in E0486 - then click 'search'.
This will bring you to the list of oral appliances covered by Medicare and which laboratories can fabricate them (ergo 14 different styles of Herbst device). As you scroll down, you will notice that some were approved and then lost their Medicare coverage (effective end date) some got it back; others did not because they did not meet the definition of a Medicare covered appliance. Those with no date in the 'effective end date' continue to be covered by Medicare.
Reducing AHI to below 5 and resolution of symptoms is the standard accepted definition of success with a treatment for sleep apnea. Many authors use a looser definition of success, as do ENT surgeons, of decreasing the AHI by 50% and bringing the final AHI <20 because it makes their treatment look better. The recent trend has been to report data with all accepted definitions of success (there are at least 6 that include AHI data) so that studies can be compared in reviews as more data is generated. Any single study cannot be used to determine any trend unless it includes really large numbers of patients. Oral appliance literature is always problematic because there are such small numbers of patients.
One study about the new diagnosis of high blood pressure, in those with sleep apnea, lumedp moderate sleep apneics with mild sleep apneics but Marin, JAMA 2012 (1886 subjects) showed that the incidence of high blood pressure in those with untreated moderate sleep apnea is much higher than those with untreated mild sleep apnea; all groups with untreated sleep apnea had a higher probability of a new diagnosis of high blood pressure than those who had no sleep apnea at all; this trend was not seen in the Sleep Heart Health Study - but most of those patients had only mild sleep apnea. Dr. Redline would know better than I about medical outcomes in those with untreated mild or moderate sleep apnea since she is an author on many similar papers.
The FDA recently had a workshop with representatives of all those involved in treating sleep apnea. This includes AASM, ASA, neurologists, pulmonologists, ENTs and dentists. One of the questions addressed is exactly what should be the criteria for 'success' when presenting an oral appliance or other device to the FDA. An interesting discussion took place and AHI was considered to be only part of the equation, but one that can be easily quantified.
Information on this meeting can be found at: https://www.gpo.gov/fdsys/pkg/FR-2018-03-08/html/2018-04629.htm
A paper will be written and published on the outcome decisions.
The only way to determine if your sleep apnea is under control is to have your sleep physician order an overnight sleep test with the oral appliance in place.
It is extremely rare that an oral appliance would correct the sleep apnea and not the snoring (In fact, in 30 years of being a sleep apnea dentist I have never seen it). Oral appliances stop snoring 80% of the time and fully control sleep apnea 37-60% of the time (depending on lots of variable). If you are snoring, you still have sleep related breathing issues.
Science is science, not a turf war. Regardless of the origin.
More is written about myofunctional therapy in the medical literature. Properly done studies with controls, controlling for confounders, etc. is the difference between proper care and supportive and alternate care.
We know that the relief of excessive tiredness with an oral appliance (CPAP too) is no better than with a placebo effect from well controlled studies; this is why looking at biomarkers such as blood pressure, natiuretic hormones, and mRNA is so critical in outcomes studies.
In looking at the studies of breathing, the most important part has to do with free nasal breathing. Other 'forms' of breathing, well known by singers, those who do yoga, etc, have nothing to do with how you breathe in your sleep when all control is based on the central nervous system and not voluntary muscles.
Lack of rigorous science means that imagination, belief and 'clinical experience' drive quasi-medical care and makes physicians wary of dealing with dentists who do not demand similar science from their sources.
Have you bothered to check the ingredients?
The address for ProDent.com is a UPS store in Carlsbad, CA.
The Vodka soak helped you or the appliance?
Alcohol is bad for all acrylics used in oral appliances and will lead to premature cracking and breakage.
Stay with cleaners recommended for orthodontic retainers and be aware there are special cleaners if the appliance contains any metal parts; these are normally sold with a sign saying "Safe for Partial dentures".
Some companies recommend use of an antiseptic hand soap and a soft tooth brush because there is less chemical reaction with appliance components. This does leave a soapy taste that will go away if you then soak the appliance in clean water.
Sleep Dental Consultant to MyApnea.Org