Apnex Medical announced today that preliminary data from a first-in-man clinical study showed significant improvements in sleep for people suffering from obstructive sleep apnea (OSA). The Apnex HGNS™ System, developed by the St. Paul-based company, is a device designed to treat OSA, which is a serious life-threatening illness characterized by fragmented sleep and excessive day-time sleepiness. The HGNS System activates an upper airway muscle during sleep, which opens the airway, allowing patients to breathe and remain asleep.
"These results demonstrate the potential benefits the HGNS System could provide to patients who do not tolerate continuous positive airway pressure (CPAP) therapy," said Peter Eastwood, Ph.D., Senior Research Fellow at the West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, Professor at the School of Anatomy and Human Biology, University of Western Australia, and an investigator with this study. "In most patients, the Apnex HGNS System reduced the severity of their OSA condition, allowing them to sleep better and feel better."
Three- and six-month data from the Australian first-in-man study evaluating the safety and efficacy of the HGNS System were presented today by Dr. Eastwood, as part of the session, "New Treatment Approaches for Lung Disease: Late Breaking Abstracts," at the American Thoracic Society (ATS) 2010 International Conference. The findings show the HGNS System reduced the severity of OSA by an average of over 50%, as measured by the apnea-hypopnea index (AHI). AHI measures the number of times per hour during sleep that a person either stops breathing or has restricted breathing. Patients also experienced significant improvements in symptoms, as measured by multiple quality of life surveys. Patients tolerated the treatment well, with an average of 6.5 hours of use each night. There were no device failures during the study.
"These data give us confidence that the HGNS System works, patients use it, and patients sleep better because of it," said Robert Atkinson, Apnex Medical president and chief executive officer. "They have improved oxygen levels during sleep and are waking up less, which we believe can lead to better overall health. We are learning a tremendous amount about this new therapy, which we believe will lead to even better outcomes through therapy adjustment and patient selection. We are excited about our on-going clinical trials in the United States and Australia, the results of which will support future applications for commercial approval."
CU Boulder study sheds light on sex differences in sleep patterns