Research & Publications

New Device to Treat OSA Patients Who Can’t Tolerate CPAP’s

Date Posted: Sunday, October 5th, 2014 by Alan Berger

The annual SLEEP meeting is the world’s largest gathering of sleep professionals.  This past June the meeting was held in Minneapolis, Minnesota.  One of the highlights of the meeting was the recent Food and Drug Administration (FDA) approval of a new device to treat obstructive sleep apnea (OSA).  This device is intended to treat patients with moderate to severe OSA who are intolerant of continuous positive airway pressure (CPAP)

Designed by Inspire Medical Systems, Inc. (Maple Grove, MN), the device is a surgically implanted system that stimulates the hypoglossal nerve to prevent airway collapse during sleep. In patients with sleep apnea, it has been demonstrated that the airway narrows and may even completely collapse during sleep.  The system resembles a small pacemaker device that is currently used for patients with heart problems.  Essentially, the device is able to sense when abnormal breathing patterns occur and sends an impulse to the hypoglossal nerve. The hypoglossal nerve, in turn, gently thrusts the tongue forward and opens the airway to restore normal breathing patterns.  This upper airway stimulation occurs throughout the night without awakening the patient.  In the morning, the patient is able to turn the device off with a handheld remote.

Donald Sesso, DO, director of the Pennsylvania Snoring and Sleep Institute, was one of the lead investigators who studied the efficacy and safety of this device.  This project was referred to as the STAR trial.  The STAR trial demonstrated a 68% reduction in apnea severity (AHI reduction) and significant improvement in daytime fatigue and quality of life measurements in the 126 patients studied(1).  Furthermore, the device was proven safe with a less than 1% serious adverse outcome rate.  Follow-up results have shown that 123 of the 126 implanted patients are still using the device after 18 months of therapy.

“As a sleep surgeon, this device fills a void that was missing from our treatment algorithm”, said Dr. Sesso, who has performed this procedure on patients.  Furthermore, he said, “while the traditional airway surgical procedures that we perform today remain the gold standard of surgical treatment, this device offers a benefit that other surgeries do not.  The Inspire device allows a surgeon to titrate or adjust the device to account for changes in the airway over years.” He said that as a patient ages, their airway may become smaller due to weight gain or loss of airway muscle tone, among other reasons.  This may be the reason that some people stop snoring for years after airway surgery, but the snoring returns many years later.  In addition, many people may notice that their CPAP pressure may need to be increased as they age in order to control their OSA.  This device enables surgeons to account for these changes by programming the device to meet a patients changing needs throughout their lifetime.

While this device is not appropriate for all patients with sleep apnea, it offers new hope to those who cannot tolerate CPAP.  If you snore or have sleep apnea, you should seek medical attention.  Critical in your sleep exam is an upper airway evaluation to determine which treatment option may be best for you.

(1)  New England Journal of Medicine.  2014;370:139-149.