Status:
UNKNOWN
Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
Lead Sponsor:
Fitbit LLC
Conditions:
Sleep Apnea
Eligibility:
All Genders
18+ years
Brief Summary
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. ...
Eligibility Criteria
Inclusion
- Capable of giving informed consent
- Comfortable reading the provided written study instructions in English (and/or local language) and using a smartphone in English (and/or local language).
- Have medical insurance either in the form of private insurance or a national health program.
Exclusion
- No implanted cardiac devices
- Not pregnant. Pregnancy status will be confirmed per patient report of medical history, i.e., patients will be asked if they are pregnant or may be pregnant, and date of last menstrual cycle.
- No medical conditions which might lead to consistently low levels of perfusion in the vasculature at the wrist
Key Trial Info
Start Date :
November 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT03775291
Start Date
November 9 2018
End Date
April 30 2023
Last Update
August 22 2022
Active Locations (6)
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1
Jasper Summit Research
Jasper, Alabama, United States, 35501
2
Peninsula Sleep Center
Burlingame, California, United States, 94010
3
Sleep Center Orange County
Irvine, California, United States, 92604
4
Neurotrials Inc
Atlanta, Georgia, United States, 30342