FLEXIBLE SKIN-ADHESIVE PATCH FOR DIAGNOSING SLEEP DISORDERED BREATHING

Somnarus, Inc., Mountain View CA

Investigators

Abstract

DESCRIPTION (provided by applicant): The objective of this study is to test the feasibility of an innovative flexible skin-adhesive device that diagnoses obstructive sleep apnea and other sleep disordered breathing. Sleep apnea is a common disease that leads to hypertension, diabetes and cardiovascular disease. Sleep disordered breathing is commonly diagnosed with polysomnography and portable sleep monitors. The existing diagnostic solutions are expensive and are not readily available to the vast majority of patients, eighty percent of whom remain undiagnosed. This pilot clinical research study is designed to compare the innovative diagnostic device SomnaPatch with polysomnography. Patients with sleep disordered breathing (obstructive and central sleep apneas and Cheyne-Stokes respiration) and healthy controls will be recruited for this study. The specific aims are to improve the design of the SomnaPatch device; and to assess the agreement between the SomnaPatch device and polysomnography. If this research study shows good agreement between the two techniques, the BandAid-like SomnaPatch device can potentially be integrated into clinical practice of sleep specialists, dentists and primary care physicians as an easy-to-use, inexpensive, reimbursable tool for the diagnosis of sleep disordered breathing. SomnaPatch can reach currently undiagnosed patients and help prevent the devastating long-term consequences of untreated obstructive sleep apnea.