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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: patch

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hisham Alshaer, MD, PhD; Phone Number: 7959 416-597-3422; Email: Hisham.Alshaer@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2A2
      • Recruiting
      • Toronto Rehabilitation Institute
      • Principal Investigator: Clodagh Ryan, MD
      • Contact: Clodagh Ryan, MD; Phone Number: 416 340 4719; Email: Clodagh.Ryan@uhn.ca
    • Toronto, Ontario, Canada, M5G 2C4
      • Not yet recruiting
      • Toronto General Hospital
      • Principal Investigator: Clodagh Ryan, MD
      • Contact: Clodagh Ryan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wearable Device and PSG; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of AHI	Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of body position	Validate the performance of the patch in estimating body position during sleep compared to an in-laboratory PSG.	8 months

Collaborators and Investigators

• Sponsor: BresoTEC Inc.
• Investigators: Principal Investigator: Clodagh Ryan, MD, Toronto General Hospital & Toronto Rehabilitation Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2018
• Primary Completion (Anticipated): August 23, 2019
• Study Completion (Anticipated): August 23, 2019

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: CL-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No