Self-Dispensing Respiratory Effort Band (5R44HL68532-02)

Eden Medical has been awarded a $589,317 Phase II National Institutes of Health(NIH) Small Business Innovative Research(SBIR) grant by the National Heart Lung and Blood Institute(NHLBI) to develop a disposable self-dispensing respiratory effort band to reliably detect subtle apnea and improve registration of sleep disordered respiratory events. The effects of sleep disordered breathing, including obstructive apnea syndrome (OAS) and Cheyene-Stokes breathing lead to excessive daytime sleepiness, high blood pressure, heart failure and stroke. The incidence of apnea-related fragmented sleep and cardiovascular abnormalities continues to increase, affecting up to 18 million Americans and 4% of the middle-aged adult population. Existing effort band technology has a number of problems including sensitivity to sleep patient movement (i.e. repositioning) causing data inconsistency; band slippage causing poor respiratory event registration; and restrictive patient fit resulting in patient discomfort. The Phase II project focused on the development of an effort band that can be self-dispensed like a roll of tape, offering a low-cost disposable product that eliminates custom band sizes and effort band tension setting via loop or buckle setting, and improves detection of subtle apnea for sleep patients. A smart garment fashioned into an effort band is being developed to sense thoraco-abdominal respiratory movement. This low-cost self-dispensing method of sensing respiratory rate could significantly improve detection of sleep-disordered breathing through “full-circumference” respiratory event characterization.Eden Medical has successfully completed a clinical test with 20 sleep apnea patients in 2009.