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Trial Underway Testing Sleep Apnea Stimulation Device

Sleeping woman

(Aweisenfels, Wikimedia Commons)

11 May 2015. A clinical trial testing an experimental neurostimulation device to treat obstructive sleep apnea implanted the device in its first two test patients. The trial is sponsored by ImThera Medical Inc. in San Diego, the developer of the aura6000 device being tested.

Obstructive sleep apnea is a disorder where muscles in the throat intermittently relax and block the airway during sleep, causing snoring and repeated stopping and starting of breathing. The pattern of repeated breathing stoppages can interrupt regular sleep, resulting in disrupted sleeping routines. The condition can lead to daytime fatigue from lack of sleep and cardiovascular complications, such as high blood pressure and abnormal heart rhythms. The disorder can also make it more difficult to administer sedatives and general anesthesia.

ImThera Medical developed the aura6000 system, a device using electronic pulses to stimulate the nerve in the brain controlling the tongue. The system uses principles of neurostimulation to prevent the tongue from falling back and blocking the airway. The company says the short bursts of electronic pulses are delivered to an electrode positioned under the skin near the lower jaw, from a pulse generator implanted in the chest, to stimulate the hypoglossal nerve controlling tongue muscle movements.

The clinical trial is testing the aura6000 device among 141 individuals in the U.S. and Europe with moderate to severe obstructive sleep apnea, who did not respond or cannot tolerate usual therapies, such as positive airway pressure and oral appliances. All participants will have the device surgically implanted, but the half of the group, randomly selected, will have the system turned on after 1 month. The other half of the group will receive the usual standard of care for sleep apnea. Participants will be evaluated after 4 months, on the number of sleep interruption events per hour and blood oxygen levels, as well as safety indicators, including serious adverse events.

ImThera conducted two previous clinical trials for safety and efficacy of the aura6000. The company received a CE mark in March 2012, clearing the device for marketing in Europe. The new clinical trial is aimed at providing evidence to support an application for similar approvals from the U.S. Food and Drug Administration.

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