New Help for Sleep Apnea
(Ivanhoe Newswire) — There may be a new treatment for obstructive sleep apnea (OSA) on the horizon. Researchers have received approval from the FDA to begin a clinical trial to evaluate an investigational device known as the Hypoglossal Nerve Stimulation (HGNS) System.
According to the World Health Organization, about 100 million people worldwide suffer from OSA. It happens because of a blockage of breathing during sleep, which can deprive patients of deep sleep and lead to a variety of health problems including high blood pressure, coronary artery disease, diabetes and stroke.
The new study, sponsored by Apnex Medical, is a randomized, multi-center clinical trial being conducted at medical centers in the United States, Europe and Australia. It will include patients with moderate to severe OSA who have not received lasting relief from CPAP or other treatments.
“Many patients who suffer from OSA are unable to tolerate existing therapies such as continuous positive airway pressure (CPAP). The HGNS System provides a fundamentally new approach to the treatment of OSA. This study will help us further understand the potential role this device will have in treating the millions of people who suffer from OSA,” the study’s co-principal investigator, Dr. Atul Malhotra, Clinical Chief, Division of Sleep Medicine, Brigham and Women’s Hospital, was quoted as saying.
The HGNS System works by restoring neuromuscular activity to the genioglossus muscle by stimulating the hypoglossal nerve synchronous with inspiration to mitigate upper airway collapse during sleep. This is similar to how the body’s natural neuromuscular physiology functions in people without OSA.
“We have seen very encouraging results from the HGNS feasibility studies. Results recently presented at the international SLEEP meeting showed that most patients treated with the HGNS System experienced significant improvements in their sleep apnea, sleepiness, and quality of life. This study will help us determine if these results can be demonstrated in a second larger patient population,” the study’s co-principal investigator, Dr. Eric Kezirian, Department of Otolaryngology — Head and Neck Surgery, University of California, San Francisco, was quoted as saying.
SOURCE: Apnex Medical Press Release, August 2011