Validation of a Wearable Non-invasive Device (the Patch)
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2018
CompletedFirst Submitted
Initial submission to the registry
January 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2019
CompletedJanuary 25, 2019
January 1, 2019
8 months
January 23, 2019
January 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Estimation of AHI
Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.
8 months
Secondary Outcomes (1)
Estimation of body position
8 months
Study Arms (1)
Wearable Device and PSG
EXPERIMENTALThe 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
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BresoTEC Inc.lead
Study Sites (2)
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clodagh Ryan, MD
Toronto General Hospital & Toronto Rehabilitation Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2019
First Posted
January 25, 2019
Study Start
December 23, 2018
Primary Completion
August 23, 2019
Study Completion
August 23, 2019
Last Updated
January 25, 2019
Record last verified: 2019-01