BGailDemko140

There is no accepted definition of treatment response for surgery or oral appliance therapy, only CPAP; that is why we often borrow their definition of success. At present, most studies on oral appliances report three outcomes: how many people drop the AHI by 50% (a surgical definition), how many drop the AHI below 15 and how many drop the AHI below 5. The number of breathing events has been used as a measurement for years because we can measure it. There is a significant move to look at the amount of time you spend with an oxygen saturation below 90% as the next new measurement to be used in evaluating treatment outcomes. This is a young field and we are still working out all the bugs and trying to get at the core.

I am not sure what you mean by updated research on the effectiveness of oral appliances. Last count, there were more than 700 articles on oral appliance therapy (from 1986- to present) all of which show a statistical improvement in all studied outcomes (AHI, oxygen saturation, quality of life, blood pressure, you name it.) Research is ongoing to look at the impact appliances have on diabetes and A1C. To date, looking at 30 years of data, CPAP is effective in 90-95% of patients, jaw surgery in 75% of patients, oral appliances in 55-50% of patients and soft tissue surgery, less than that. These are studies over only a 1-year period. Long term impact is less well studied. But CPAP has been around since 1981 and I have read posts from those who have used it fir more than 20 years. That speaks volumes right there. I have only one patient who has used his oral appliance for > 20 years.

Sleep Apnea never goes away. It gets worse with age, weight gain and other medical conditions. It is like diabetes and requires daily treatment.

Now we look to reviews of the literature and improved study design.

Surgical therapy for sleep apnea is a big field. There are multiple options of soft tissue throat surgery, (most of which have fallen out of use over the past 20 years), implantable pacing for the nerves that control the tongue, or surgical movement of both the upper and lower jaw called maxillomandibular advancement surgery or ‘telegnathic’ surgery. Ear nose and throat doctors do the soft tissue and implant surgery while specially trained oral surgeons do the movement of the jaws.

Soft tissue surgery has been known to be less effective than oral appliances therapy for more than a decade and this was reviewed in an article by Adam Elshaug and others in the journal of Sleep in 2007. Simple in-office procedures using a laser or a procedure called radioablation have been shown to be somewhat effective for the treatment of snoring but ineffective in the treatment of sleep apnea. (Camacho et al published a review of laser surgeries in 2007 and one of their conclusions was that they did not believe laser assisted uvulopalatoplasty should be done at all because 44% of patients got worse.) Caples and his coauthors wrote in 2010 that previous styles of throat surgery were poorly studied (who wants to have pretend surgery to see if a procedure really works?) but that newer techniques appeared promising. Van Maanen did a study in 2012 where the AHI dropped from 36 to 25. I know of no sleep physician that would accept that as a final number of breathing events per hour and call that ‘success’. Implantable devices show much promise, but insurance companies do not, as of yet, cover this surgery because they consider it experimental. Ear nose and throat doctors are working more with newer procedures and doing a great deal of patient evaluation to try and ‘hand pick’ patients who are more likely to be effectively treated. Many studies suggest not treating anyone over 55 years of age or who are significantly overweight. When looking at jaw surgery, I was lucky enough to lecture in Korea with Kasey LI, MD, DDS (a very impressive surgeon in California) and he said in his lecture that it appears as if jaw surgery fails around 15 years and he has patients comping back to do the whole thing again. Look at his website for more information: www.SleepApneaSurgery.com Bariatric surgery is the best option for patients who are more than 100 lbs. overweight. While all the studies show that weight loss does not cure sleep apnea, it will seriously improve it. To go from very severe apnea to mild or moderate sleep apnea will allow previously ineffective treatments to become effective. Weight loss / weight control should be part of any treatment plan for sleep apnea.

As far as the literature shows, there is no treatment except CPAP that does not fail with time. It seems much easier to increase CPAP pressure over the years than to go through repetitive surgeries. This is why there is such a push to have patients try CPAP. While many patients feel they cannot tolerate it, sleep physicians and technicians work every day to try and help you find a set-up that works and is comfortable. The future holds a team approach for every patient to help find what will be optimal treatment for each individual. This will include sleep physicians, Ear Nose and Throat doctors, dentists, psychologists and others. Those of us in the field wish we could figure out how to predict which patient will be successful with any single treatment option. Only CPAP works for 90-95% of patients.

There are no websites of which I know that talk about treatment failures. I have a library of more than 2000 medical and dental articles that I access when discussing treatments and 27 years of experience.

For most people.

Interestingly, snoring often goes away before the sleep apnea does. Snoring is controlled in over 80% of the people who get an oral appliance. So it may indicate an effective device, but not always. The TAP family of devices is often made starting at a natural jaw position and you then moves the jaw forward. Since the TAP allows around 10 mm of movement, this may be inadequate to get you to an effective position. The EMA is normally fabricated at an advanced position to start and it may be easier to get your jaw out further. Just to muddy the water, some people can move their jaw too far and, get worse. See if you can compare the two appliances to make sure they are the same forward position. Then look to see if the distance between the front teeth is the same. Your dentist may need to alter the position of the hardware on your new appliance. The dental work must have been extensive because an EMA can usually be adjusted around changes in dental work (as can most hard appliances) unless the crown was way too bulky on the tongue side or cheek side.

Medicare will cover a follow-up sleep study to verify the effectiveness on an oral appliance just as they cover a CPAP titration study. Your sleep physician can arrange this.

Jaw advancement is dependent on each patient. Some move a lot, some not at all. In the only study evaluating patients wearing an oral appliances for 15-20 years showed tooth movement in all of them. So 2 things can happen: 1. Tooth movement and 2. Movement of the entire jaw. Research is ongoing as to whether jaw repositioners help or if the results I want to see are really there. I have patients who, after 20 years, have moved their jaw almost 1/2"; in dental terms that is scary but he doesn't care. He eats fine, speaks fine and continues to be productive at work. I have others at 10 years who have no changes.

An unusual type of device for large tongues is a Tongue Retaining Device (Not covered by Medicare). This holds your tongue forward in a suction bulb and was developed years before the jaw movement style that most of us dentists use today. I started doing oral appliances in 1989 and limited my practice to sleep dentistry in 1997...in all that time, only 3 patients were able to tolerate a tongue device long term.

Since the tongue is only one part of sleep apnea, surgical procedures are less effective long term than CPAP or an oral appliance which address many more blockage locations than behind the tongue. Recent studies done at hospitals working with Harvard Medical School have shown that the tongue does not collapse as much as was once thought. These studies will help us better predict who will benefit from an oral appliance based on data collected from your laboratory sleep study.

There are two studies that looked at this exact topic. Interestingly they showed a significant racial differences, the cutoff point for Asians is 10.5 cm.

Sutherland et al 201. CPAP pressure for prediction of OAT response in OSA (Sleep Vol 10, No 9 943- 949)

Tsuiki 2010. Optimal positive airway pressure predicts OAT response to sleep apnea. (Eur Resp J 2010 35: 1098-1105)

As with all treatments, there are outliers and people who respond when not expected to.

They work in most people (more that 55%) . There are 4 major reasons people get sleep apnea, only 2 of them are related to the patient's anatomy, and abnormal anatomy is what an oral appliance fixes. This does not mean what the patient looks like to the physician or dentist, but how the muscles work and how well the brain controls breathing. An effective appliance is based on an action used during anesthesia to keep the airway to the lungs open prior to placing a breathing tube.This does not work in people who have throat blockages close to their voice box or in those people who have the throat close from all sides rather than just front to back or side to side. That being said, More than half of the people tested completely controlled their sleep apnea when using an oral appliances. Another 25% had a good response, but not perfect.

These appliances are most effective in thin, young patients, but what isn't? CPAP does not have these limitations. Medical insurance (not dental) covers oral appliances, even Medicare. All insurance companies require a trial of CPAP if you are diagnosed with severe sleep apnea.

People love their oral appliances (and yes, there are large numbers of people who love their CPAPs). It is important to offer patients choices in the treatment of their sleep apnea.

Knowing the literature is important when reporting on which device is 'more effective'. Hoekema's data is more than 10 years old and was done looking only at the TAP 1. The TAP 1 was made from pieces supplied by the parent company and actually fabricated to Dr. Hoekema's specifications by his own laboratory...a much more controlled fabrication that seen from most dental laboratories (dental technicians in the US are not required to have any training and there is no requirement that they know what they are doing). One study done comparing the effectiveness of two different appliances (TAP 1 and a Herbst style device) showed an initial advantage of the TAP device ( by a very small number of breathing events) but, by 2 years, the improvement in breathing events was similar and more people had stopped using their TAP appliance. With over 30 studies scientifically comparing one device to another, there is no consistent device that is more effective than another. In Japan , where insurance reimbursement is poor, dentists must make do with prefabricated devices (bought in bulk on line) and fitted by a dentist. Those devices fitted by a dentist are almost as effective as a custom fabricated one provided by a dentist.

As Dr. Luisi states, he is more effective in treating patients with mild - moderate sleep apnea, so is every dentist. Every study has a different definition of success some of which say, that if the number of breathing events is cut in half and ends up under 20 / hour that is 'success'. No sleep physician would accept a residual number of breathing events of 20 (still moderate sleep apnea) when titrating a patient with CPAP. Physicians Titrate CPAP until the number of breathing events is less than 5/hour. This level of breathing events has been shown to resolve all negative complications that occur with untreated sleep apnea. Hoekema's study (2004) showed an excellent response to oral appliance therapy but every patient had more than 2 laboratory sleep studies. If the study showed the patient did not respond well, the oral appliance was adjusted in hope of improving outcomes. This cannot be compared to a normal procedure for a dental provider who does not follow the same rigid guidelines as in the study.