SBIR-STTR Award

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.

Thesaurus Terms:
Adhesives;Agreement;Base;Blood;Cardiovascular Diseases;Central Sleep Apnea;Cheyne-Stokes Respiration;Clinical Practice;Clinical Research;Data;Data Analyses;Dentists;Design;Development;Device Designs;Devices;Diabetes Mellitus;Diagnosis;Diagnostic;Diagnostic Procedure;Disease;Flexibility;Goals;Health;Health Care Costs;Heart Diseases;Heart Rate;Home Environment;Hypertension;Improved;Innovation;Instruction;Measures;Methods;Morbidity - Disease Rate;Multi-Institutional Clinical Trial;Nose;Obstructive Sleep Apnea;Oxygen;Patients;Phase;Photoplethysmography;Physiological;Pilot Projects;Polysomnography;Preparation;Prevent;Primary Care Physician;Primary Health Care;Prototype;Public Health Relevance;Quality Of Life;Records;Recruitment Activity;Reporting;Research Clinical Testing;Research Project Grants;Research Study;Respiration Disorders;Respiratory;Respiratory Therapy;Risk;Signal Transduction;Skin;Sleep;Sleep Apnea Syndromes;Small Business Innovation Research Grant;Solutions;Specialist;Techniques;Technology;Test Result;Testing;Time;Timeline;Tool;Training;

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 Statement:


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.

NIH Spending Category:
Bioengineering; Cardiovascular; Clinical Research; Lung; Sleep Research

Project Terms:
Adhesives; Algorithms; Cardiovascular Diseases; Clinical; clinical practice; Clinical Research; Clinical Trials; Computer software; cost; Data Analyses; Development; Device or Instrument Development; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Event; flexibility; Future; Goals; Health; Health Care Costs; Hypertension; improved; innovation; Instruction; Marketing; Methods; Modification; Morbidity - disease rate; Obstructive Sleep Apnea; Patients; Phase; Physiological; Polysomnography; Preparation; prevent; public health relevance; Quality of life; Records; Recruitment Activity; Reporting; research study; Respiration Disorders; respiratory; Respiratory Therapy; Risk; Skin; Sleep; Sleep Apnea Syndromes; software development; Solutions; System; Technology; TimeLine; tool; Training; validation studies; Work