Sleep Apnea
Conditions
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.
Interventions
DEVICEpatch
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.
Sponsors
BresoTEC Inc.
Study design
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The outcome assessor performing the automatic analysis of the patch data will be blinded to the PSG scores performed by the Sleep Lab Technicians. The principal investigator responsible for the completion and closing of the study according to the protocol will be blinded to the patch AHI automatic analysis. Similarly, the Sleep Lab Technicians scoring the PSG will be blinded to the patch automatic analysis. By the end of recruiting the target sample size, the data will be un-blinded and statistical analysis will be performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of AHI | 8 months | Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of body position | 8 months | Validate the performance of the patch in estimating body position during sleep compared to an in-laboratory PSG. |
Countries
Canada
Contacts
Primary ContactHisham Alshaer, MD, PhD
Outcome results
None listed