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

Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders (SLeeP AID4): An Observational, In-Home, Single-Group, Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Sleep; Sleep Disturbance; Pregnancy Related; Sleep-Disordered Breathing
• Intervention / Treatment: Device: Infrared video-audio camera; Device: Level III home sleep apnea test; Device: Maternal-fetal transabdominal electrocardiographic heart rate monitor; Device: Pressure sensing mat

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Research Lead; Phone Number: (416) 360-4000; Email: al731156@dal.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1L5
      • Recruiting
      • University of Toronto
      • Contact: Elham Dolatabadi, PhD
      • Principal Investigator: Elham Dolatabadi, PhD
      • Sub-Investigator: Sebastian Hobson, PhD
      • Sub-Investigator: Allan Kember, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA; Device: Level III home sleep apnea test; NightOwl® by Ectosense, Leuven, Belgium
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bed partner 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)
Maternal obstructive sleep apnea	Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.	4 nights (approximately 32 hours)
Bed partner obstructive sleep apnea	Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.	4 nights (approximately 32 hours)
Maternal limb movements	Average nightly periodic limb movement index (number of limb movements per hour)	4 nights (approximately 32 hours)
Bed partner limb movements	Average nightly periodic limb movement index (number of limb movements per hour)	4 nights (approximately 32 hours)
Maternal restless legs syndrome	Present or absent, as determined by participant self report.	4 nights (approximately 32 hours)
Bed partner restless legs syndrome	Present or absent, as determined by participant self report.	4 nights (approximately 32 hours)
Maternal total sleep time (TST)	Average nightly total sleep time in minutes as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Bed partner total sleep time (TST)	Average nightly total sleep time in minutes as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Maternal time in bed (TIB)	Average nightly total time the participant is in bed.	4 nights (approximately 32 hours)
Bed partner time in bed (TIB)	Average nightly total time the participant is in bed.	4 nights (approximately 32 hours)
Maternal sleep efficiency	Average nightly percentage of total time in bed spent sleeping (ratio of TST to TIB multiplied by 100%).	4 nights (approximately 32 hours)
Bed partner sleep efficiency	Average nightly percentage of total time in bed spent sleeping (ratio of TST to TIB multiplied by 100%).	4 nights (approximately 32 hours)
Maternal rapid eye movement (REM) sleep duration	Average nightly time of REM sleep in minutes as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Bed partner rapid eye movement (REM) sleep duration	Average nightly time of REM sleep in minutes as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Maternal snoring	Present or absent as determined by manual review of audio from infrared video.	4 nights (approximately 32 hours)
Bed partner snoring	Present or absent as determined by manual review of audio from infrared video.	4 nights (approximately 32 hours)
Minimum maternal heart rate (HR)	Averaged nightly minimum HR, in beats per minute, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Minimum maternal respiration rate (RR)	Averaged nightly minimum, in breaths per minute, as determined by manual review of audio and video from the infrared video data.	4 nights (approximately 32 hours)
Minimum bed partner respiration rate (RR)	Averaged nightly minimum, in breaths per minute, as determined by manual review of audio and video from the infrared video data.	4 nights (approximately 32 hours)
Minimum bed partner heart rate (HR)	Averaged nightly minimum HR, in beats per minute, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Minimum maternal peripheral blood oxygen saturation (SpO2)	Averaged nightly minimum, in percent, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Minimum bed partner peripheral blood oxygen saturation (SpO2)	Averaged nightly minimum, in percent, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Maximum maternal heart rate (HR)	Averaged nightly maximum HR, in beats per minute, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Maximum bed partner heart rate (HR)	Averaged nightly maximum HR, in beats per minute, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Maximum maternal respiration rate (RR)	Averaged nightly maximum, in breaths per minute, as determined by manual review of audio and video from the infrared video data.	4 nights (approximately 32 hours)
Maximum bed partner respiration rate (RR)	Averaged nightly maximum, in breaths per minute, as determined by manual review of audio and video from the infrared video data.	4 nights (approximately 32 hours)
Maximum maternal peripheral blood oxygen saturation (SpO2)	Averaged nightly maximum, in percent, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Maximum bed partner peripheral blood oxygen saturation (SpO2)	Averaged nightly maximum, in percent, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Average maternal heart rate (HR)	Averaged nightly mean HR, in beats per minute, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Average bed partner heart rate (HR)	Averaged nightly mean HR, in beats per minute, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Average maternal respiration rate (RR)	Averaged nightly mean, in breaths per minute, as determined by manual review of audio and video from the infrared video data.	4 nights (approximately 32 hours)
Average bed partner respiration rate (RR)	Averaged nightly mean, in breaths per minute, as determined by manual review of audio and video from the infrared video data.	4 nights (approximately 32 hours)
Average maternal peripheral blood oxygen saturation (SpO2)	Averaged nightly mean, in percent, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Average bed partner peripheral blood oxygen saturation (SpO2)	Averaged nightly mean, in percent, as determined by the home-sleep apnea monitor.	4 nights (approximately 32 hours)
Maternal heart rate variability - root mean square of successive differences	Averaged nightly beat-to-beat variation as measured by the root mean square of successive differences (RMSSD).	4 nights (approximately 32 hours)
Fetal heart rate variability - root mean square of successive differences	Averaged nightly beat-to-beat variation as measured by the root mean square of successive differences (RMSSD).	4 nights (approximately 32 hours)
Maternal heart rate variability - standard deviation of NN intervals	Averaged nightly beat-to-beat variation as measured by the standard deviation of N-N intervals (SDNN).	4 nights (approximately 32 hours)
Fetal heart rate variability - standard deviation of NN intervals	Averaged nightly beat-to-beat variation as measured by the standard deviation of N-N intervals (SDNN).	4 nights (approximately 32 hours)
Maternal skin pressure distribution thorax	Averaged nightly mean pressure, in pounds per square inch (PSI), in the thorax region.	4 nights (approximately 32 hours)
Maternal skin pressure distribution abdomen	Averaged nightly mean pressure, in pounds per square inch (PSI), in the abdominal region.	4 nights (approximately 32 hours)
Maternal skin pressure distribution pelvis	Averaged nightly mean pressure, in pounds per square inch (PSI), in the pelvic region.	4 nights (approximately 32 hours)
Average fetal heart rate (FHR)	Averaged nightly mean FHR, in beats per minute, as determined by the ambulatory maternal-fetal heart rate monitor.	4 nights (approximately 32 hours)
Minimum fetal heart rate (FHR)	Averaged nightly minimum FHR, in beats per minute, as determined by the ambulatory maternal-fetal heart rate monitor.	4 nights (approximately 32 hours)
Maximum fetal heart rate (FHR)	Averaged nightly maximum FHR, in beats per minute, as determined by the ambulatory maternal-fetal heart rate monitor.	4 nights (approximately 32 hours)

Collaborators and Investigators

• Sponsor: Shiphrah Biomedical Inc.
• Collaborators: Mitacs; University of Toronto
• Investigators: Principal Investigator: Elham Dolatabadi, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: SBI-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Participants' study data will not be released outside of the study team without the written permission of the participant, except as necessary for duty to report or force of law (i.e., by subpoena). Study data will not be made open access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No