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Validation of a Wearable Non-invasive Device (the Patch)
N/A
Waitlist Available
Led By Clodagh Ryan, MD
Research Sponsored by BresoTEC Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Sleep Apnea
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Estimation of AHI
Secondary study objectives
Estimation of body position
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Wearable Device and PSGExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
patch
2019
N/A
~100
Find a Location
Who is running the clinical trial?
BresoTEC Inc.Lead Sponsor
Clodagh Ryan, MDPrincipal InvestigatorToronto General Hospital & Toronto Rehabilitation Institute