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

Not Applicable

• Conditions: Sleep Apnea
• Interventions: Device: patch

• Registration Number: NCT03816566
• Lead Sponsor: BresoTEC Inc.

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.

Study Timeline

• Study Start: 2018-12-23
• Status Verified: 2019-01
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-23
• Last Update Submitted: 2019-01-23
• Study First Posted: 2019-01-25
• Last Update Posted: 2019-01-25
• Primary Completion: 2019-08-23
• Study Completion: 2019-08-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Wearable Device and PSG	patch	The device under investigation (the patch) will be used in patients undergoing overnight polysomnography simultaneously, to compare the accuracy of the investigational device against the gold standard for the diagnosis of sleep apnea.

Primary Outcome Measures

Name	Time	Method
Estimation of AHI	8 months	Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.

Secondary Outcome Measures

Name	Time	Method
Estimation of body position	8 months	Validate the performance of the patch in estimating body position during sleep compared to an in-laboratory PSG.

Trial Locations

Locations (2)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada