Status:
UNKNOWN
Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders
Lead Sponsor:
Shiphrah Biomedical Inc.
Collaborating Sponsors:
Mitacs
University of Toronto
Conditions:
Pregnancy Related
Sleep
Eligibility:
All Genders
18-50 years
Brief Summary
SLeeP AID4 is a single-group, single-arm, Canada-wide, non-randomised, unblinded, in-home, observational study to prospectively collect and build a data set of natural sleep behaviour and physiology i...
Eligibility Criteria
Inclusion
- Participant
- Healthy (see American Society of Anesthesiologists Physical Status \[ASA-PS\] classification; participant must be ASA-PS class II or lesser)
- Have a singleton pregnancy
- Be in the third trimester (gestational age between 28 weeks and 0 days through 40 weeks and 6 days, inclusive, by first-trimester ultrasound)
- Live in a home with a 2.4 GHz Wi-Fi network
- Sleep in a bed at night (i.e., not a La-Z-Boy chair or similar)
- Participant's Bed Partner (if applicable)
- Sleep in the same bed as the pregnant study participant.
- Healthy (see American Society of Anesthesiologists Physical Status \[ASA-PS\] classification; participant must be ASA-PS class II or lesser)
- Participant
Exclusion
- Non-English speaking, reading, or writing
- ASA-PS class III or greater
- Participant's Bed Partner (if applicable)
Key Trial Info
Start Date :
July 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05376475
Start Date
July 6 2022
End Date
June 30 2024
Last Update
October 28 2022
Active Locations (1)
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1
University of Toronto
Toronto, Ontario, Canada, M5G 1L5