The Battle for Oral Appliance Legitimacy

The Battle for Oral Appliance Legitimacy

The Battle for Oral Appliance Legitimacy

If you’re living in a fox hole, CPAP is highly inconvenient. Army physicians took this simple truth and turned it into a study that has buoyed the case for adjustable oral appliances.


CPAP compliance can be challenging under ideal conditions. Add the dust, sand, and lack of electricity under combat conditions, and therapy adherence can be virtually impossible.


Major Aaron B. Holley, MD, FACP, ran an ICU unit in Afghanistan for 6 months where he treated combat-related injuries. He saw the harsh Arab landscape firsthand, a place where proper sleep is not a priority. Even in cases of clearly identified sleep apnea, most troops could not afford to give up pack space for CPAP devices and batteries.


Back home at Walter Reed National Military Medical Center (WRNMC), Bethesda, Md, Holley and Lt Col Christopher J. Lettieri, MD, FACP, FCCP, FAASM, continued their work to improve sleep for veterans. They believed that if oral appliances (OAs) were as effective as they were convenient, they could ultimately contribute to a stronger fighting force.


Lettieri, Holley, and additional colleagues attempted to find the answer to this question, ultimately publishing research in the CHEST Journal. The study, titled “Efficacy of an Adjustable Oral Appliance and Comparison with CPAP for the Treatment of Obstructive Sleep Apnea Syndrome”, confirmed excellent results among mild to moderate sleep apnea sufferers.


Accidents and Explosions
Not surprisingly, the quality of sleep among soldiers can be a shambles during combat deployment. Explosions and less-than-ideal sleeping arrangements are unavoidable, but combined with sleep apnea can be even worse. “We know that most injuries are not battle related,” says Lettieri, a co-author of the study. “We have accidents, and if soldiers are sleep deprived, they are going to lack focus and be more prone to accidents.”


It’s a problem on U.S. roadways, but the stakes are even higher when lethal machinery is mixed in. “If you are driving a 40-ton tank around, you can’t afford to make bad decisions,” adds Lettieri, program director, Sleep Medicine Fellowship, WRNMC. “Research shows that chronic low-level sleep deprivation impairs reasoning, decision-making, and slows reaction time. You don’t want that in a combat-deployed troop.”


Beyond the obvious benefits of reduced accidents and convenient placement in a ruck sack, they found that even post traumatic stress disorder (PTSD) may be affected by poor sleep. “We have all these guys coming back with PTSD, and we broke it down into guys who were injured, and those who were not,” explains Lettieri. “Among guys who did not sustain a combat injury, almost universally they had some underlying sleep disorder.”


“When I was over there, we were sleeping next to an air field,” adds Holley. “It’s the nature of deployment that you don’t get a fixed and regular sleep schedule. Even if you take out PTSD and the anxiety of being subjected to mortars and rockets, you still have a situation where people are getting disturbed and fragmented sleep at best.”

Between 2004 and 2006, the Walter Reed sleep clinic gave out oral appliances and CPAP to service men and women on active duty. “When they went to a place without electricity, it would cause problems and sometimes even prevent some people from being able to go overseas,” explains Holley. “The dusty dirty environment made CPAP too difficult to keep clean. Filters in the machines were frequently going down and having problems.”


Large Pool Yields Better Findings
Armed with findings from one of the largest patient populations to date, Army researchers found that adjustable OAs are nearly as effective as CPAP treatment for patients with mild to moderate OSA, and are more effective than fixed oral appliances—particularly in patients with moderate to severe OSA.

“Historically, CPAP has been the primary treatment for OSA, but only half of patients tolerate this therapy,” says Lettieri, an Army medical director, and the chief of Sleep Medicine in the Pulmonary, Critical Care and Sleep Medicine Department at WRNMMC. “This new data offers a fresh look at adjustable oral appliances as an initial treatment for OSA in both the military and civilian sectors.”

The military is interested in the potential of adjustable OAs, also called mandibular advancement devices, as alternatives to CPAP systems since some active duty service members deploy to remote environments where electricity is not always available. In these cases, reliance on CPAP may result in duty restrictions or separation from service. “Adjustable OAs would eliminate duty assignment limitations associated with CPAP, allowing soldiers to travel to remote areas as needed,” adds Lettieri.


The study in CHEST evaluated and compared results of overnight sleep studies in which patients used adjustable OAs or CPAP devices. Researchers found that a significantly higher percentage of patients using an adjustable OA experienced successful reduction of their AHI score to below five apneic events per hour, compared to past reports (62.3% versus 54%).


In most research trials of oral appliances, patients receive oral appliances after they have already failed with CPAP.  It amounts to a selection bias because patients have already failed, and researchers often never really know why they failed. “We thought our data set was unique because a fair proportion of our patients did not fail CPAP since they were given both at the same time,” explains Holley. “The problem with doing this in the real world is you run into cost limitations. It is not cheap to do either of these therapies individually, never mind giving both to everyone up front. This is true in the military or civilian world.”


Changing Perceptions
Holley contends that physician “CPAP followers” are fairly devoted, tending to favor the humidification features of the modality. “Some docs are comfortable with what they are comfortable with, regardless of the evidence, even when it is compelling,” laments Holley. “It takes time to change people’s minds. How much will change with this study is hard to say. I would hope we have at least shifted the thought process and debate so that pulmonologists like me are more likely to not automatically go to CPAP for mild to moderate. It really does work just about as well as CPAP for people who have mild to moderate disease.”


Lettieri and Holley believe the study will (and should) contribute to a shift toward considering OAs earlier in the patient experience. More comparisons with CPAP are necessary, but Holley admits it can be difficult to level the playing field. “CPAP is electronic with a smart card that records compliance,” he says. “We know exactly how well it’s working. The struggle with studying oral appliances is that you must rely on self reporting from patients as to how much they use it. We can prove that oral appliances work, but the next thing to prove is if patients actually wear them more than CPAP. We suspect they do, but we have yet to prove it.”


Building the case is something that Lettieri is content to do. As a 40-year-old physician in a relatively young field, he has seen awareness grow exponentially, and he has helped the military change its perceptions. At Walter Reed, the size of the sleep lab has doubled in recent years and the staff has tripled. Consults have gone from 70 per month to often 70 in a day.


In a culture where sleep deprivation is part of the culture, Lettieri admits that raising awareness has not always been easy. “When I enlisted, the recruiting slogan was ‘We do more by 9:00 a.m. than most people do all day,’” he muses. “We get up early and operate at night. There is a sleep-when-you-can mentality. Americans as a whole keep shortening their average sleep time at night. Since the 1970s, we have about 1.3 hours less per night. The military is even worse.”



SIDEBAR: Military Intelligence
As program director of the Sleep Medicine Fellowship at Walter Reed National Medical Center, Bethesda, Md, Lt Col Christopher J. Lettieri, MD, FACP, FCCP, FAASM, has seen the evolution of sleep medicine. In a culture where sleep deprivation is often considered a badge of honor, the 40-year-old Lettieri has succeeded by educating top brass and soldiers alike with a powerful message: Well-rested soldiers are more effective in the field of battle.

Nowadays, the sleep lab at Walter Reed is a full-fledged sleep disorders center that is recognized as a center of excellence. In addition to pulmonologists, neurologists, pediatricians, and even psychiatrists are applying for fellowship training. Sleep Diagnosis & Therapy sat down with Lettieri to talk about the explosion in sleep awareness and the implications for the military.


How tough is it to get proper rest in the military?
Lettieri: If you are talking about deployment, your sleep quality gets worse because you go from the relatively quiet environment to sleeping among a bunch of other people. There is more noise, radios, helicopters, explosions, and the constant stress.


Is sleep apnea more or less common in the military population?
Lettieri: Sleep apnea is common in general, and it’s common in the military. Even though we tend to be younger and more physically fit, we still have a lot of sleep apnea.


Why is that?
Lettieri: Some of it is anatomic, but a lot of it has to do with chronic low level sleep deprivation. You lose your ability to maintain tone of your upper airways. Back when I was a fellow, I did a research study called, “Obstructive Sleep Apnea Syndrome: Are We Missing an At Risk Population.” Across America, most people thought about sleep apnea in the 55 year-old overweight guy snoring in your waiting room. But really you see it in younger, thinner people. And if you don’t think about it, you’re going to miss the diagnosis.


Are physicians outside of the sleep realm starting to think about sleep apnea outside of the stereotypical patient categories?
Lettieri: With some of my prior research, and in a lot of the lectures I do now, I am trying to get people to think about it in the less typical person, such as the younger girl with chronic headaches and depression. Or the young guy who has unexplained fatigue and ADHD. I’ve always thought we had a lot of it in the military because of this chronic low level sleep deprivation.


Are there examples among fit combat soldiers?
Lettieri: We have had young, active duty guys who get diagnosed with sleep apnea. If it is toward the earlier part of the war, what do you do with them? You cannot bring CPAP in the theater with you. If you’re living in a fox hole, where are you going to plug it in?

Are CPAPs possible at the larger bases?
Lettieri: Even with the more mature theaters we have now, where everybody has laptops plugged in and lamps, you still can’t plug in a CPAP. The Central Command that runs the war said you can’t bring it.

So what do you do now? You’ve got a young guy, and if you tell him he has sleep apnea, he may be out of a job. The alternative is oral appliances.


When did oral appliances emerge as a viable alternative?
Lettieri: A couple of years ago, when we started this, oral appliances were largely considered an alternative to CPAP. You could consider oral appliances if they had a really mild disease, or really hated CPAP.


What do you with young guys who have severe disease?
Lettieri: You can’t say, ‘Well you’re out of the army.’ So we pushed the envelope way beyond what was accepted, because we didn’t want anyone to be forced out of the Military because of sleep apnea” At one point, we had more experience with oral appliances than most of the country combined. We had to get this message out, so we published two papers almost back to back.


Why did you focus so much on the oral appliances?
Lettieri: We did it largely to conserve the military fighting strength. On one hand, we want to find alternatives to CPAP, because while it is great, lots of people don’t like it.


Across the country, it’s a constant battle with better adherence. You can say that with all medical care, but the difference with CPAP is it has an integrated compliance monitoring device. So we look at this thing and we can tell exactly when the person used it. Some people abandon therapy, and roughly only half of people on CPAP have regular use of their therapy. That’s terrible.

CPAP may be great, but if people aren’t going to use it, we’ve got to have another treatment option. For us on a more personal note, we also have to maintain the fighting strength. We must be able to send people into combat.

You don’t diagnose sleep apnea, and then let soldiers go out with an untreated medical disorder. That is not good for anybody. In that case, you are taking very sleepy people and putting them in harm’s way, and you’re going to see more accidents.


How effective are oral appliances?
Lettieri: Nothing’s perfect by any means, but even half of the people with severe disease got what we considered to be adequate therapy. It depends on where you draw your line in the sand.


“We use strict criteria for what we consider to be effective therapy.  It would be hard to argue with this criteria, so most people would have to agree that adjustable oral appliances work.” If we realize that only half the people are actually using their CPAP anyway, then you’re no worse off. Even if CPAP were completely effective, half the people are not going to use it.


What do you think of non adjustable or fixed devices?
Lettieri: The problem is that you get one shot to fix them. We found that they are OK, but only for really mild disease. Anyone with moderate to severe, you need adjustable. And these are ones you can titrate, just like you do when adding a higher dose of a medication or a range of pressures with CPAP. Adjustable ones ought to be used, and are probably more cost effective in the long term because more people get adequate therapy.


What do you think of tongue control devices?
Lettieri: These are essentially suction bulbs affixed to your tongue that pulls your tongue forward. They really don’t work well—maybe for very mild disease they can be adequate. Most patients find them uncomfortable and they are not used much in clinical practice.