Recruiting

Observational Study

Sponsor:

Shiphrah Biomedical Inc.

Code:

NCT05376475

Conditions

Pregnancy Related

Sleep

Sleep-Disordered Breathing

Sleep Disturbance

Sleep Disorder

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Infrared video-audio camera

Level III home sleep apnea test

Maternal-fetal transabdominal electrocardiographic heart rate monitor

Pressure sensing mat

Study Details

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 in maternal-fetal dyads (and bed partners, if applicable) in the third trimester of pregnancy in the home setting and subsequently investigate the feasibility of using computer vision technology (CVT) to monitor sleep during and across the third trimester of pregnancy in the home setting for research purposes by eliciting participants' attitudes toward CVT and training, validating, and testing a CVT model to accurately, unobtrusively, non-invasively, and objectively detect and quantify various sleep behaviours, disturbances, and disorders.

Conditions

Pregnancy Related

Sleep

Sleep-Disordered Breathing

Sleep Disturbance

Sleep Disorder

Study ID

NCT05376475

Start date

Jul 6, 2022

Status verified date

Oct, 2022

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Participant Inclusion Criteria:

  • 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) Inclusion Criteria:

  • 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 Criteria:

  • Non-English speaking, reading, or writing
  • ASA-PS class III or greater

Participant's Bed Partner (if applicable) Exclusion Criteria:

  • Non-English speaking, reading, or writing
  • ASA-PS class III or greater

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Virtual setup cohort

Participants in this cohort will use a night vision camera and level III home sleep apnea test. If the participant has a bed partner who consents to be in the study, the bed partner will also use a level III home sleep apnea test and be recorded by the night vision camera.

In-person setup cohort

Participants in this cohort will use a night vision camera, a level III home sleep apnea test, a maternal-fetal transabdominal electrocardiographic heart rate monitor, and a pressure sensing mat. If the participant has a bed partner who consents to be in the study, the bed partner will also use a level III home sleep apnea test and be recorded by the night vision camera (maternal-fetal transabdominal electrocardiographic heart rate monitor and a pressure sensing mat will not be used by the bed partner).

Interventions

Infrared video-audio camera

Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA

Level III home sleep apnea test

NightOwl® by Ectosense, Leuven, Belgium

Maternal-fetal transabdominal electrocardiographic heart rate monitor

The Monica AN24 Antenatal Fetal Holter by Monica Healthcare, Nottingham, UK

Pressure sensing mat

Tactilus® V Series Mattress Pressure Monitoring System by Sensor Products Inc., Madison, USA

Primary outcome measure

  • Maternal supine sleep position [ Time Frame: 4 nights (approximately 32 hours) ]

Central Contacts and Locations

Central contacts

Research Lead

(416) 360-4000al731156@dal.ca

Locations

University of Toronto

Recruiting

Toronto, Ontario, Canada, M5G 1L5

Principal Investigator:

Elham Dolatabadi, PhD

More Information

Sponsor

Shiphrah Biomedical Inc.

Last update posted

Oct 28, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shiphrah Biomedical Inc. on 2022-10-28.