Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders (SLeeP AID4)

Shiphrah Biomedical

Status: Enrolling

Conditions: Sleep Disorder; Pregnancy Related; Sleep Disturbance; Sleep-Disordered Breathing; Sleep

Treatments: Device: Pressure sensing mat; Device: Level III home sleep apnea test; Device: Maternal-fetal transabdominal electrocardiographic heart rate monitor; Device: Infrared video-audio camera

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05376475

SBI-007

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

60 participants in 2 patient groups

Virtual setup cohort

Description:

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.

Treatment:

Device: Infrared video-audio camera

Device: Level III home sleep apnea test

In-person setup cohort

Description:

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).

Treatment:

Device: Maternal-fetal transabdominal electrocardiographic heart rate monitor

Device: Infrared video-audio camera

Device: Level III home sleep apnea test

Device: Pressure sensing mat