St. Luke's Hospital Among First To Launch Pivotal Study of Implantable Sleep Apnea DeviceSt. Luke's Sleep Medicine and Research Center is now enrolling qualified participants in the Apnex® Clinical Study.
CHESTERFIELD, MO, November 14, 2011 - St. Luke's Sleep Medicine and Research Center is now enrolling participants in a clinical study to evaluate the safety and effectiveness of the Apnex® Hypoglossal Nerve Stimulation (HGNS®) System, an implantable device, to treat obstructive sleep apnea (OSA). The center is among the first worldwide to begin enrollment for this new study of the investigational device, and it is the only study site in the bistate area.
"Continuous positive airway pressure (CPAP), which involves a pressurized mask over the nose, is considered the 'gold standard' for the treatment of sleep apnea, but many people have difficulty tolerating it," said Paula Schweitzer, PhD, St. Luke's Sleep Medicine and Research Center director of research. "This implantable device offers a new approach for those who have not had success with CPAP or other sleep apnea treatments."
People interested in learning if they qualify for the Apnex Clinical Study may call 888-975-3370 or visit stlukes-stl.com/sleep. Qualified participants will receive the medical device and care free of charge.
About Obstructive Sleep Apnea:
According to the World Health Organization, approximately 100 million people worldwide have OSA. In the United States, symptomatic OSA affects one in four men and one in nine women. It most often occurs when the airway muscles fail to keep the airway open during sleep. 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. Current OSA treatments are not always successful or well tolerated.
About the Apnex HGNS System:
The Apnex HGNS System is an implanted medical device that activates muscles of the upper airway to ensure that the airway remains open during sleep. During sleep, the system monitors the patient's breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the tongue. As the nerve is stimulated, the tongue gently moves forward to keep the airway open.
About the Apnex Clinical Study:
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 had success with CPAP or other OSA treatments. The study is being performed by sleep specialists at clinical study centers in the U.S., Australia and Europe.