Validation of a Wearable Non-invasive Device (the Patch)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03816566
Study type	Interventional
Source	BresoTEC Inc.
Contact	Hisham Alshaer, MD, PhD
Phone	416-597-3422
Email	Hisham.Alshaer@uhn.ca
Status	Recruiting
Phase	N/A
Start date	December 23, 2018
Completion date	August 23, 2019

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