New Oral Interface May Appeal to Sleep Apnea Patients

Pittsburgh, PA - May 29, 2001

Sleep apnea patients may have a more comfortable alternative choice for treatment, according to researchers at the Center for Sleep Disorders at the Western Pennsylvania Hospital.

The most often prescribed treatment for sleep apnea now is a mask that is secured to the face and head with Velcro straps. The mask is attached to a machine that produces continuous positive air pressure (CPAP). Traditionally, air has been forced into the nose to splint open the patient's throat while he or she sleeps. While usually minor, up to 60 percent of the patients develop nasal congestion and skin irritation using the nasal mask.

Now, for the first time in many years, there appears to be a promising alternative, according to Lewis Kline, M.D., director of the Center for Sleep Disorders at West Penn. Dr. Kline and researchers from Fisher & Paykel Healthcare of New Zealand are developing an oral interface device called the Vestibular-in-line Pressure System, which is known commercially as Oracle.

In the first U.S. clinical trial, Dr. Kline treated 19 patients with the Oracle, which is a strapless, butterfly-shaped device that rests between the lips and teeth. The preliminary results showed the device to be a suitable alternative with similar usage rates as the nasal mask. Although some patients experienced discomfort as a result of airway drying and minor gum irritation, there were fewer complaints of air leaks, nasal congestion, skin irritation and initial claustrophobia with the Oracle than with the nasal mask.

"The findings are encouraging. From what we've seen, this has the potential to be the most promising oral interface to be developed in years," Dr. Kline said.

Sleep apnea affects as many as 5 percent of the population worldwide and is a condition in which a person is awakened many times during sleep as their body reacts to frequent, short periods of time (called apneas) when the person has stopped breathing. Those with sleep apnea usually suffer from profound sleepiness that may interfere with work and other activities.

Dr. Kline and his colleague, Ritu Khanna, M.D., will present their findings at the 15th Annual meeting of the Associated Professional Sleep Societies June 5-10 in Chicago.