Recruiting

Wearable Device

Sponsor:

BresoTEC Inc.

Code:

NCT03816566

Conditions

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

patch

Study Details

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.

Conditions

Sleep Apnea

Study ID

NCT03816566

Start date

Dec 23, 2018

Status verified date

Jan, 2019

Completion date

Aug 23, 2019

Anticipated

Primary completion date

Aug 23, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Estimation of AHI [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Hisham Alshaer, MD, PhD

416-597-3422Hisham.Alshaer@uhn.ca

Locations

Toronto Rehabilitation Institute

Recruiting

Toronto, Ontario, Canada, M5G 2A2

Contacts

Clodagh Ryan, MD

416 340 4719Clodagh.Ryan@uhn.ca

Principal Investigator:

Clodagh Ryan, MD

More Information

Sponsor

BresoTEC Inc.

Last update posted

Jan 25, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BresoTEC Inc. on 2019-01-25.