Physicians in the division of sleep medicine at the Medical College of Wisconsin are conducting a clinical research study at Froedtert Hospital to assess an innovative, minimally invasive, implantable device as a treatment for sleep apnea.

B. Tucker Woodson, MD, Medical College of Wisconsin otolaryngologist, is principal investigator for this multi-institutional national study. This study will evaluate the effectiveness of a small device that is implanted under the chin for the purpose of opening the airway and reducing or eliminating Obstructive Sleep Apnea (OSA). This device is implanted during a brief surgical procedure. Later, it is individually adjusted, as needed, for each individual patient, to reduce or stop collapse and open the airway.

The most common symptom of OSA is loud snoring and daytime sleepiness or fatigue. Individuals eligible for the study must be between ages 18 and 65, have a prior diagnosis of sleep apnea and have been unsuccessfully treated by more conventional treatments.

OSA is a common disorder affecting more than 17 million people in this country. Unfortunately, only one in four receives successful treatment. OSA has now been linked to such health risks as high blood pressure, cardiovascular disease, stroke and congestive heart failure. It can also affect our daily life by making one excessively sleepy during the day. OSA sufferers may have employment problems and fall asleep while driving, watching television or carrying on a conversation.

"Many of the current treatments of sleep apnea are too poorly tolerated or too invasive," says Dr. Woodson. "The goal of this study is to assess whether an implantable device that opens the lower throat can affect sleep apnea. Since this device can be implanted during a minor surgical procedure and is later adjusted for each individual, side effects and complications may be very low. If successful, such devices may revolutionize surgical treatment of the disease."

The study is being supported by Aspire Medical of Sunnyvale Calif., developers of the Advance™ System.

Author: Eileen La Susa

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