Status:
UNKNOWN
Validation of a Wearable Non-invasive Device (the Patch)
Lead Sponsor:
BresoTEC Inc.
Conditions:
Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 23 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03816566
Start Date
December 23 2018
End Date
August 23 2019
Last Update
January 25 2019
Active Locations (2)
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1
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M5G 2A2
2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4