The objective of this study is to further develop and validate the SomnaPatch(tm), an innovative flexible skin-adhesive device that diagnoses obstructive sleep apnea and other sleep disordered breathing. The company's goal is to offer the device and the SomnaCloud(tm) sleep data analysis software as a complete solution. 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 project includes a large multi-center clinical validation study. Patients at risk for sleep disordered breathing will e recruited for the clinical study.
The specific aims are to improve the SomnaPatch(tm) device and the SomnaCloud software and to definitively prove clinical validity of the diagnostic solution. If the proposed work is carried out successfully, the diagnostic solution will be poised to gain regulatory approval by FDA and to be integrated into clinical practice as an easy-to-use, inexpensive, reimbursable tool for the diagnosis of sleep disordered breathing. The Somnarus products can help reach currently undiagnosed patients and help prevent the devastating long-term consequences of untreated obstructive sleep apnea.
Millions of people in the US suffer from sleep apnea - a respiratory disorder during sleep. Most of the patients remain undiagnosed because the existing methods are too expensive and are not readily available. This research study aims to show that SomnaPatch(tm) device and SomnaCloud software offer an accurate, easy-to-use and inexpensive diagnostic solution that can be readily available to patients at risk for sleep apnea.
