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

Sleep Clinical Trial

— SLeeP AID4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05376475
• Other study ID #: SBI-007
• Status: Recruiting
• Start date: July 6, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2022
• Source: Shiphrah Biomedical Inc.
• Contact: Research Lead
• Phone: (416) 360-4000
• Email: al731156[@]dal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Pregnancy Related
• Sleep
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders
• Sleep-Disordered Breathing

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Shiphrah Biomedical Inc.	Mitacs, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Maternal obstructive sleep apnea	Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.	4 nights (approximately 32 hours)
Secondary	Bed partner obstructive sleep apnea	Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.	4 nights (approximately 32 hours)
Secondary	Maternal limb movements	Average nightly periodic limb movement index (number of limb movements per hour)	4 nights (approximately 32 hours)
Secondary	Bed partner limb movements	Average nightly periodic limb movement index (number of limb movements per hour)	4 nights (approximately 32 hours)
Secondary	Maternal restless legs syndrome	Present or absent, as determined by participant self report.	4 nights (approximately 32 hours)
Secondary	Bed partner restless legs syndrome	Present or absent, as determined by participant self report.	4 nights (approximately 32 hours)
Secondary	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)
Secondary	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)
Secondary	Maternal time in bed (TIB)	Average nightly total time the participant is in bed.	4 nights (approximately 32 hours)
Secondary	Bed partner time in bed (TIB)	Average nightly total time the participant is in bed.	4 nights (approximately 32 hours)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Maternal snoring	Present or absent as determined by manual review of audio from infrared video.	4 nights (approximately 32 hours)
Secondary	Bed partner snoring	Present or absent as determined by manual review of audio from infrared video.	4 nights (approximately 32 hours)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Maternal skin pressure distribution thorax	Averaged nightly mean pressure, in pounds per square inch (PSI), in the thorax region.	4 nights (approximately 32 hours)
Secondary	Maternal skin pressure distribution abdomen	Averaged nightly mean pressure, in pounds per square inch (PSI), in the abdominal region.	4 nights (approximately 32 hours)
Secondary	Maternal skin pressure distribution pelvis	Averaged nightly mean pressure, in pounds per square inch (PSI), in the pelvic region.	4 nights (approximately 32 hours)
Secondary	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)
Secondary	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)
Secondary	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)