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.
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
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
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.
Toronto Rehabilitation Institute
Toronto, Ontario, Canada
RECRUITINGToronto General Hospital
Toronto, Ontario, Canada
NOT_YET_RECRUITINGEstimation of AHI
Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.
Time frame: 8 months
Estimation of body position
Validate the performance of the patch in estimating body position during sleep compared to an in-laboratory PSG.
Time frame: 8 months
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