Novel Method to Study Sleep in Autistic Disorders

DESCRIPTION (provided by applicant): Pro-Tech Services, Inc. proposes to develop an innovative technology to study sleep in human subjects. Pulse Transitional Slope (PTS) technology measures autonomic nervous system (ANS) activity during sleep and offers significant advantages over polysomnography (PSG), the current gold standard for sleep study. The PTS device is portable, noninvasive, and easier to use than PSG. At the same time, PTS offers strong correlation to PSG with greater diagnostic sensitivity and substantial cost savings. PTS will benefit the large numbers of patients waiting for a sleep study. In particular, PTS answers a tremendous need in the rapidly growing population of people with autistic spectrum disorder (ASD). ASD sufferers exhibit a high rate of sleep disorders but can rarely tolerate invasive methods of studying sleep, such as PSG. Actigraphy, the most common method used to diagnose sleep disorders in those with ASD, is noninvasive but not sensitive enough to collect sleep diagnostic data, which is why the American Academy of Sleep Medicine states that actigraphy "should not be used in sleep studies for diagnostic purposes." Phase I work on Pro-Tech's proposed PTS technology will involve significant hardware and software development and will include clinical trials on human subjects to prove technological feasibility. Phase II work will complete the design work and result in advanced prototypes and software that fully integrates into a sleep laboratory's existing sleep diagnostic PSG products. Given the high demand and high costs of current sleep study technology, PTS offers great commercial potential. Commercial versions will be available as 1. A software-only product that integrates into existing sleep laboratory PSG software and takes advantage of the pulse oximeter probes that laboratories already use; and 2. A portable hardware-software device that uses a HIPPA-compliant wireless wrist-worn pulse oximeter that transits data to a receiver. Using the portable device, clinicians can monitor the test real-time via a secure Internet connection or store data for post-test download and analysis.