Validation of a Wearable Non-invasive Device (the Patch) to Aid in Diagnosing Sleep Apnea

BresoTEC Inc.2 sites in 1 country60 target enrollmentDecember 23, 2018

ConditionsSleep Apnea

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sleep Apnea
Sponsor: BresoTEC Inc.
Enrollment: 60
Locations: 2
Primary Endpoint: Estimation of AHI
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

BresoTEC has designed and developed a standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject.

Detailed Description

The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy. We have developed advanced signal processing algorithms to detect apneas and hypopneas. Many of these techniques for analyzing breathing sounds and detecting apneas and hypopneas have been published in peer-reviewed journals. The goal of this study is to validate the patch against polysomnography (PSG) for use as an aid in the diagnosis of sleep apnea for adult patients. Our primary objective is to assess whether the estimated apnea-hypopnea index (AHI) calculated by the patch agrees with the results of an in-laboratory PSG.

Registry

clinicaltrials.gov

Start Date

December 23, 2018

End Date

August 23, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

BresoTEC Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria are men and women 18 years and above, who are referred to either the University Health Network (UHN), Toronto Rehabilitation Institute (TRI) or Toronto General Hospital sleep laboratories for overnight PSG because of a suspicion of a sleep disorder. It is intended for the general outpatient population.

Exclusion Criteria

•Exclusion criteria are patients with suspected complicated co-morbidities including in-hospital patients and those who self-report diagnosis of heart failure, recent stroke, neuromuscular disorders, renal failure, obesity hypoventilation, COPD, or other severe lung diseases.