Inspire Medical to Test Implanted Device for Sleep Apnea

According to the National Institutes of Health, about 12 million Americans suffer from sleep apnea, a potentially life-threatening condition. CPAP machines are prescribed for most to control symptoms, but many find them cumbersome and uncomfortable, leading many to be noncompliant with treatment. Inspire Medical Systems is testing an implanted device that stimulates the nerves in the tongue, opening the airways during sleep for better breathing.

Common Cause of Sleep Apnea is Tongue Relaxation

The most common type of sleep apnea is obstructive sleep apnea (OSA). During sleep, the airway collapses and the blockage causes shallow breathing or breathing pauses. One common cause is a relaxation of the tongue that causes it to cover air passages. Breathing pauses can last from a few seconds to minutes and often occur 5 to 30 times or more an hour. OSA is more common in people who are overweight, but it can affect anyone, even children.
Untreated sleep apnea can increase the risk of high blood pressure, arrhythmias, heart attack, heart failure, stroke, obesity and diabetes. Due to inadequate sleep, sleep apnea can also increase the chance of having a work-related or driving accident.
Inspire Medical Systems, based in Minneapolis MN, has developed a new device that works by stimulating the hypoglossal nerve in the tongue with a mild electrical current, causing the muscle to constrict. The small pacemaker-like device is implanted under the skin near the collarbone and a wire attached to the hypoglossal nerve. A sensor at the diaphragm detects when a patient takes a breath, signaling the implant to send a current.
The power of the current will be adjusted so that the nerve is stimulated just enough to keep the tongue from falling backward during sleep, thus not blocking the airway, but not too much as to cause the tongue to stick out. Patients can turn on the device at bedtime with a remote control and preset the device to turn on and off at certain times.
Inspire plans to begin enrolling 100 sleep apnea patients in January for a key study to see if their hypoglossal nerve stimulation implant device will work. Two other US competitors have also announced small-scale testing. Potential patients will be required to undergo a special exam to determine if tongue collapse is the true cause of the apnea.
Until approved for use, patients with obstructive sleep apnea should work with their healthcare providers or a sleep specialist to find the best CPAP machine for their individual needs. Continuous Positive Airway Pressure machines are today’s undisputed best treatment, but as many as 30% of patients discontinue use because of masks that fit poorly or other reasons such as a feeling of claustrophobia.