Newswise — DETROIT – A clinical trial is underway at Henry Ford Hospital to evaluate the safety and effectiveness of the Apnex® Hypoglossal Nerve Stimulation (HGNS®) System to treat obstructive sleep apnea (OSA).
Henry Ford is the only medical facility in Michigan, and among the first in the country, to participate in this study.
The Apnex HGNS System is a surgically implanted medical device that activates muscles of the upper airway to ensure that the airway remains open during sleep. While asleep, the system monitors the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, which controls the tongue. As the nerve is stimulated, the tongue gently moves forward to keep the airway open.
The stimulation is timed to a patient’s own breathing pattern. The device automatically turns on when the patient is sleeping, and turns off when the patient is awake.
“Some people with obstructive sleep apnea are unable to tolerate existing therapies, such as continuous positive airway pressure, or CPAP,” says study co-principal investigator Kathleen L. Yaremchuk, M.D., chair of Otolaryngology-Head & Neck Surgery at Henry Ford Hospital.
“The HGNS System provides a new approach to the treatment, and this study will help us further understand what role this device could have in treating the millions of people who suffer from obstructive sleep apnea.”
The Henry Ford study is being led by Dr. Yaremchuk and Thomas Roth, Ph.D., Division Head of Sleep Disorders and Research at Henry Ford.
Approximately 100 million people worldwide have OSA, according to the World Health Organization. In the U.S., symptomatic OSA affects one in four men, and one in nine women.
This sleep disorder occurs due to the collapse of the airway muscles in the throat during sleep. The blocked airway causes loud snoring and periodic pauses in breathing, sometimes hundreds of times a night. This can lead to excessive daytime sleepiness, and as a result decreased quality of life and an increased risk for injuries from motor vehicle accidents.
Untreated OSA increases the risk of death; as well as stroke, high blood pressure, coronary artery disease, heart failure and diabetes. It causes fragmented sleep which leads to excessive daytime sleepiness, resulting in an increased risk of accidents and lost productivity.
The treatment of choice for has been CPAP therapy during sleep, which uses a machine to increases air pressure in the throat to prevent the airway from collapsing. But CPAP, along with other OSA treatments, are not always successful or well tolerated.
The purpose of the Apnex Clinical Study is to determine whether the Apnex HGNS System is a safe and effective treatment for OSA in patients who have not received lasting benefit from CPAP or other OSA treatments. The study is being performed by sleep specialists at clinical study centers throughout the U.S., Australia and Europe.
The Apnex Clinical Study is now enrolling patients. Those who are interested in learning if they might qualify for the study can call (888)975-3370 (toll free) or go to www.SleepApneaTrial.com.
NOTE: The Apnex HGNS System is an investigational device and is limited by Federal (or United States) law to investigational use only.
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