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.

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 device is an accurate, easy-to-use and inexpensive diagnostic device 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 I (R43)
Project #
1R43HL123196-01
Application #
8715335
Study Section
Special Emphasis Panel (ZRG1-CVRS-M (11))
Program Officer
Twery, Michael
Project Start
2014-08-15
Project End
2015-02-28
Budget Start
2014-08-15
Budget End
2015-02-28
Support Year
1
Fiscal Year
2014
Total Cost
$303,682
Indirect Cost
Name
Somnarus, Inc.
Department
Type
DUNS #
078379113
City
Mountain View
State
CA
Country
United States
Zip Code
94043