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.

Public Health Relevance

Millions of children 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 SomnaPatchTM device is an accurate, easy-to-use and inexpensive diagnostic device that can be readily available to pediatric 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 #
1R43HL124809-01
Application #
8782027
Study Section
Special Emphasis Panel (ZRG1-CVRS-M (11))
Program Officer
Twery, Michael
Project Start
2014-08-15
Project End
2015-07-31
Budget Start
2014-08-15
Budget End
2015-07-31
Support Year
1
Fiscal Year
2014
Total Cost
$271,961
Indirect Cost
Name
Somnarus, Inc.
Department
Type
DUNS #
078379113
City
Mountain View
State
CA
Country
United States
Zip Code
94043