FLEXIBLE ADHESIVE PATCH FOR DIAGNOSING SLEEP DISORDERED BREATHING IN CHILDREN

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 for diagnosis of sleep apnea in children. Sleep apnea affects up to 6% of the general pediatric population and up to 50% of obese children. Childhood sleep apnea causes significant health, developmental and quality of life problems, such as learning deficits, cognitive, behavioral abnormalities, sleepiness, and cardiovascular morbidities. Pediatric sleep disordered breathing is diagnosed with polysomnography, which is expensive and is 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 SomnaPatchTM with polysomnography. Children at risk of sleep disordered breathing will be recruited for this study. The specific aims are to miniaturize the design of the SomnaPatchTM device to fit child's face; and to assess the agreement between the SomnaPatchTM device and polysomnography. If this research study shows good agreement between the two techniques, the BandAid-like SomnaPatchTM device can potentially be integrated into clinical practice of sleep specialists and pediatricians as an easy-to-use and inexpensive tool for the diagnosis of sleep disordered breathing. SomnaPatchTM can reach currently undiagnosed patients and help prevent the devastating long-term consequences of untreated sleep apnea, therefore, reducing the healthcare costs and improving quality of life of pediatric patients and their families.