Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders

NCT05376475 | Unknown FDA Device

• 1 other identifier: SBI-007
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maternal supine sleep position

  Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video.

  4 nights (approximately 32 hours)

Secondary Outcomes (45)

• Bed partner sleep position

  4 nights (approximately 32 hours)

• Maternal obstructive sleep apnea

  4 nights (approximately 32 hours)

• Bed partner obstructive sleep apnea

  4 nights (approximately 32 hours)

• Maternal limb movements

  4 nights (approximately 32 hours)

• Bed partner limb movements

  4 nights (approximately 32 hours)

Study Arms (2)

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.

Device: Infrared video-audio camera; Device: Level III home sleep apnea test

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).

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

Interventions

Infrared video-audio camera DEVICE

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

In-person setup cohort; Virtual setup cohort

Level III home sleep apnea test DEVICE

NightOwl® by Ectosense, Leuven, Belgium

In-person setup cohort; Virtual setup cohort

Maternal-fetal transabdominal electrocardiographic heart rate monitor DEVICE

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

In-person setup cohort

Pressure sensing mat DEVICE

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

In-person setup cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant persons with singleton pregnancies in their third trimester living in Canada and their bed partner (if applicable).

You may qualify if:

• 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)
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Shiphrah Biomedical Inc.: lead
• Mitacs: collaborator
• University of Toronto: collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5G 1L5, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Parasomnias; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elham Dolatabadi, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Lead

CONTACT

(416) 360-4000; al731156@dal.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: July 6, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)