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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03816566
• Other study ID #: CL-00001
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2018
• Est. completion date: August 23, 2019

Study information

• Verified date: January 2019
• Source: BresoTEC Inc.
• Contact: Hisham Alshaer, MD, PhD
• Phone: 416-597-3422
• Email: Hisham.Alshaer[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• patch
A standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject. 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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
BresoTEC Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of AHI	Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.	8 months
Secondary	Estimation of body position	Validate the performance of the patch in estimating body position during sleep compared to an in-laboratory PSG.	8 months