Validation of Apnea Risk Evaluation System Sleep Scoring

DESCRIPTION (provided by applicant): Obstructive Sleep Apnea (OSA) is the most common disorder observed in the practice of sleep medicine and is responsible for more mortality and morbidity than any other sleep disorder. OSA causes daytime drowsiness, and has been associated with hypertension, increased risk of congestive heart failure, coronary artery disease, myocardial infarction, cardiac arrhythmias and stroke. Untreated OSA patients are 3- 7 times more likely to be involved in industrial and motor vehicle accidents and have demonstrably slower reaction times and impaired performance on tests of vigilance, memory and executive functions. Further, the cumulative 8-year mortality has been calculated as high as 37% for patients with an RDI >20. The gold standard for the diagnosis of OSA is attended, overnight laboratory polysomnography (PSG). Advanced Brain Monitoring, Inc. designed the Apnea Risk Evaluation System (ARES) as a simplified OSA diagnostic alternative to PSG. The ARES incorporates existing knowledge on sleep-disordered breathing into an easy-to-apply system that uniquely combines physiological recordings acquired during sleep with anthropomorphic and clinical information obtained from a standardized questionnaire. Significant improvements in the ARES were accomplished in Phase II and scientific validity was demonstrated in the largest U.S. study conducted to-date (n=187) comparing laboratory PSG to unattended limited-channel in-home studies. However, significant barriers to successful commercialization of the ARES remain. To address these issues, the competing continuation proposes to modify the ARES to acquire additional signals, and make changes that will increase the system's ease-of-use for patients and clients. Clinical studies of 60 patients referred for PSG will be conducted to validate improvements to the ARES Unicorder, and will also provide additional direct comparisons to PSG. A multi-stage regulatory strategy is proposed to complete the ARES FDA clearance. Although characterized over 40 years ago, Obstructive Sleep Apnea (OSA) has only recently gained recognition as one of the world's most prevalent, undiagnosed disorders, and due to associated morbidity has been identified as a major public health concern. Despite this growing evidence that untreated OSA threatens public health, safety and productivity, recent estimates reveal that 93% of women and 82% of men with moderate to severe OSA remain undiagnosed. This failure to identify and treat OSA is estimated to cost $3.4 billion in additional medical costs per year in the U.S., resulting from increased physician visits, hospital stays and use of medications for hypertension and cardiovascular disease among untreated OSA patients. A lack of knowledge regarding OSA and other sleep disorders among primary care physicians and the general public in combination with limited access to and cost of overnight sleep studies has resulted in the current failure to diagnose and treat the majority of patients suffering from OSA.