The University Hospitals Case Medical Center is conducting  research study and clinical trials  for evaluating effectiveness of a new implantable device to treat sleep apnea.

The study is aimed to evaluate an electronic device designed to deliver mild stimulation to the main nerve of the tongue — the hypoglossal nerve — on each breathing cycle during sleep.

This stimulation is intended to restore tone to the muscles that control the base of the tongue, which prevent the tongue from collapsing and obstructing the airway during sleep.

Sleep apnea obstruction may not be the only cause for loud snoring but it does affects sleep that is not refreshing. At the same time sleep apnea equally causes daytime sleepiness and a reduced quality of life. Other disorders associated with sleep apnea include development of high blood pressure, as well as cardiovascular diseases, stroke and diabetes.

Unlike other surgical procedures, this device doesn’t require removing or permanently altering a patient’s facial or airway anatomy. Rather, the Inspire stimulator is implanted under the skin in the upper chest. A wire leads from the stimulator to the hypoglossal nerve in the neck while another wire off the stimulator gauges the air pressure from breathing. The patient uses a hand-held control to turn on the stimulator at bedtime and off when getting up in the morning.

The study is being conducted at leading medical centers across the United States and in Europe, with UH the site in Cleveland.

“Studies have shown that sleep apnea is as prevalent as adult diabetes and asthma, and the consequences of OSA [obstructive sleep apnea] range from disruptive to life-threatening,” said Dr. Kingman Strohl, principal investigator for the UH site.

“While many patients have found help with continuous positive air pressure through a CPAP [continuous positive airway pressure] nasal mask, for some patients it is too difficult to comply with, and thus ineffective.”

To find out more about the stimulation therapy for sleep apnea reduction trial and information on participating, go to theSTARtrial.com, or call 1-888-708-5047 begin_of_the_skype_highlighting            1-888-708-5047     end_of_the_skype_highlighting. To be eligible to participate in the trial, patients must have failed or not tolerated CPAP, have moderate to severe obstructive sleep apnea, and have a body mass index, or BMI, of less than 32.

 

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