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

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

Interventions

DEVICE

Infrared video-audio camera

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

DEVICE

Level III home sleep apnea test

NightOwl® by Ectosense, Leuven, Belgium

DEVICE

Maternal-fetal transabdominal electrocardiographic heart rate monitor

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

DEVICE

Pressure sensing mat

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

Sponsors & Collaborators

• Mitacs

  collaborator INDUSTRY

• University of Toronto

  collaborator OTHER

• Shiphrah Biomedical Inc.

  lead INDUSTRY

Principal Investigators

• Elham Dolatabadi, PhD · University of Toronto

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-06

Primary Completion

2023-06-30

Completion

2024-06-30

FDA Device

Yes

Countries

• Canada

Study Locations