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Jeanette Shelly of Lincoln sees Ronald Attanasio, D.D.S., for proper fit of the oral device that helps treat her sleep apnea. |
Researchers at the UNMC College of Dentistry are conducting a pilot study to evaluate the effectiveness of an oral device as an alternative non-invasive, less expensive treatment in reducing moderate sleep apnea and snoring. The college has received $7,000 to recruit and evaluate the device in 10 men and women, age 45 to 65.
Participants will be recruited through the SOMNOS Sleep Laboratory in Lincoln, which will donate its services for the study. John Trapp, M.D., a Lincoln physician specializing in sleep disorders, and Terry Stentz, Ph.D., University of Nebraska-Lincoln and director of the SOMNOS Laboratory, Inc., will collaborate on the study. Those who qualify for the study will receive oral exams, a custom-made oral device, and participate in a two-night sleep study.
Researchers say if the oral device proves effective it would be an efficient and cost-effective treatment with profound relevance in the medical and dental community, as well as in the health insurance industry.
Sleep apnea — “a silent killer”
“Sleep apnea is a silent killer that’s underdiagnosed,” said Ron Attanasio, D.D.S., professor, UNMC College of Dentistry and principal investigator of the study. “It’s a national dilemma. Loud, habitual snoring is a hallmark indicator of sleep apnea. The dental and medical community together must find alternative solutions to this problem.”
Sleep apnea, estimated to affect 6 percent of American adults, is defined as a stoppage of airflow for a period of at least 10 seconds and/or a 50 percent reduction in airflow. Less oxygen in the blood leads to an increase in blood pressure and heart rate. It can result in cardiovascular disorders, such as hypertension, stroke and heart attack.
It also causes sleep at inappropriate times, excessive daytime sleepiness, early morning headaches, depression, irritability, sexual dysfunction, and learning and memory difficulties. Snoring causes partial obstruction of the airway or stops breathing temporarily and is estimated to affect about 25 percent of adults.
Searching for answers
“Most insurance companies consider the oral device unacceptable in treating sleep apnea despite FDA approval of the device and well-controlled clinical studies,” Dr. Attanasio said. “Often, the cost of being tested and fitted for the oral device is not covered by insurance. Though small studies show success of oral devices, long-term effectiveness is not documented.
“Right now, clinically we’re relying on subjective feedback from patients about their disorder,” Dr. Attanasio said. “The study can give us objective scientific data on whether the oral appliance works. We think this device will help patients. Our goal is to do a larger study looking at moderate to severe sleep apnea.”
Treatment methods
Treatment for sleep apnea includes weight loss, medication, surgery and devices to prevent airway collapse, such as the nasal continuous positive airway pressure (CPAP), and intraoral orthotic therapy (oral devices).
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Finally she tried a CPAP. “It helped a little, but I was still tired,” she said. “It was uncomfortable. It felt claustrophobic. Sometimes I would have to use a humidifier because of the dry air it created. It was very painful.” She sought out Dr. Attanasio to make an oral device for her but found her insurance company wouldn’t pay. She wrote letter after letter. It wasn’t until her pulmonologist wrote a letter that the company approved the request. “I was jumping and screaming when the insurance company said yes. Now I have more energy, am less crabby and have far fewer headaches,” Shelly said. |
A less popular choice for sleep apnea treatment is surgery, which can be expensive, less than 50 percent effective and requires the permanent partial removal of the soft throat tissue. Side effects can include coughing, voice changes and food or fluids to be discharged from the nose.
A commonly used device, the CPAP, is worn over the face or the nose at bedtime, and works by pushing air through the nasal passages and airways, thereby preventing collapse of the airways. It can be effective, however many patients find the mask causes nasal and eye irritation, is claustrophobic and uncomfortable. Patient compliance rate is 30 to 50 percent.
Intraoral orthotic therapy, or oral devices, look like athletic mouthguards and adjust the position of the lower jaw so breathing is not obstructed during sleep. The device is easy to carry compared with the bulky CPAP.
Many times, insurance pays for the CPAP, which costs between $1,800 and $2,400, but not for the oral appliance, which costs about at $1,775.
Research team
Along with evaluating the oral appliance in the study, researchers also will evaluate new diagnostic tools that could make screening and diagnosing sleep apnea less expensive and less invasive.
Other co-investigators are Eric Fung, Ph.D., David Covey, D.D.S., dental students David Weber and Jason Vogt, and Cheon-Woo Nam, D.D.S., Ph.D., a visiting professor from the University of South Korea.
Helping others, themselves
Some of the researchers understand firsthand why it’s important to find better treatment for sleep apnea.
Dr. Attanasio has received gifts from married couples who said he saved their marriage as a result of their oral appliances. Then one day about three years ago, his wife told him he should make one for himself. “I was in denial that I snored. My wife would tell me she could hear me gasping for air at times while I was sleeping,” Dr. Attanasio said.
He later suffered from what appeared to cardiologists as a heart attack but was actually found to be sleep apnea. “I was probably one of the few people ever to be prepped for heart surgery only to have it called off at the last minute,” he said.
“Not until you have the problem do you know what people are going through,” Dr. Fung said. “A few years ago, I tried to use the CPAP, but could not tolerate the constant pressure of the air. My insurance company denied my requests for an oral appliance several times, saying it wasn’t medically necessary. This underscores the importance of doing research. We are not saying this oral appliance is the only thing. It should be another choice for patients.”