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 December
2011 issue of CHEST. The study, titled
Efficacy
of an Adjustable Oral Appliance and Comparison With Continuous Positive
Airway Pressure 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.
Originally Published At ... http://www.sleepdt.com/the-battle-for-oral-appliance-legitimacy/
Teaching dentists about sleep apnea is important because dentists are in a position to screen for this serious disease.
