BGailDemko140

BGailDemko140
Joined Nov 2015
Bio

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

US

BGailDemko140
Joined Nov 2015
Bio

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

US

Not feeling refreshed after effective treatment for sleep apnea, regardless whether it is PAP or an oral appliance, is a conundrum for science. There are multiple studies of both CPAP and oral appliances that show the improvement in how people feel does not matter between active treatment (actually using the CPAP or the oral appliance) and a placebo or inactive therapy. How can that happen? Some people feel great, others feel no difference. This has led to more studies which actually look at the various causes behind sleep apnea: how you're built anatomically, how your muscles work, central nervous system control, etc. Every person has a varying proportion of causes/ reasons behind why the sleep apnea has occurred. All it takes is one tipping point to push you over from minimal disease in to symptomatic disease. At present, physicians approach this problem by using a second approach added to the first which is hoped to treat the residual symptoms. This may be positional therapy to keep you off your back, an oral appliance, exercise regimen (better than weight loss in controlling symptoms), myofunctional therapy, medication...on and on.) One other theory behind continued symptoms is related to years and years of feeling tired might eventually rewire your brain to feel that way permanently. There is less research in this area. Just be aware that this feeling happens with all forms of therapy. 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

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.

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