Study To Asses Device For Sleep Apnea

July 14, 2007

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.

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