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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HL123196-02
Application #
8981924
Study Section
Special Emphasis Panel (ZRG1-CVRS-H (11))
Program Officer
Twery, Michael
Project Start
2014-08-15
Project End
2017-05-31
Budget Start
2015-08-15
Budget End
2016-05-31
Support Year
2
Fiscal Year
2015
Total Cost
$1,163,946
Indirect Cost
Name
Somnarus, Inc.
Department
Type
DUNS #
078379113
City
Mountain View
State
CA
Country
United States
Zip Code
94043