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 Type
OBSERVATIONAL
Enrollment
60
Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA
NightOwl® by Ectosense, Leuven, Belgium
The Monica AN24 Antenatal Fetal Holter by Monica Healthcare, Nottingham, UK
Tactilus® V Series Mattress Pressure Monitoring System by Sensor Products Inc., Madison, USA
University of Toronto
Toronto, Ontario, Canada
RECRUITINGMaternal supine sleep position
Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video.
Time frame: 4 nights (approximately 32 hours)
Bed partner sleep position
Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video.
Time frame: 4 nights (approximately 32 hours)
Maternal obstructive sleep apnea
Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.
Time frame: 4 nights (approximately 32 hours)
Bed partner obstructive sleep apnea
Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.
Time frame: 4 nights (approximately 32 hours)
Maternal limb movements
Average nightly periodic limb movement index (number of limb movements per hour)
Time frame: 4 nights (approximately 32 hours)
Bed partner limb movements
Average nightly periodic limb movement index (number of limb movements per hour)
Time frame: 4 nights (approximately 32 hours)
Maternal restless legs syndrome
Present or absent, as determined by participant self report.
Time frame: 4 nights (approximately 32 hours)
Bed partner restless legs syndrome
Present or absent, as determined by participant self report.
Time frame: 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.
Time frame: 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.
Time frame: 4 nights (approximately 32 hours)
Maternal time in bed (TIB)
Average nightly total time the participant is in bed.
Time frame: 4 nights (approximately 32 hours)
Bed partner time in bed (TIB)
Average nightly total time the participant is in bed.
Time frame: 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%).
Time frame: 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%).
Time frame: 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.
Time frame: 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.
Time frame: 4 nights (approximately 32 hours)
Maternal snoring
Present or absent as determined by manual review of audio from infrared video.
Time frame: 4 nights (approximately 32 hours)
Bed partner snoring
Present or absent as determined by manual review of audio from infrared video.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 4 nights (approximately 32 hours)
Maternal skin pressure distribution thorax
Averaged nightly mean pressure, in pounds per square inch (PSI), in the thorax region.
Time frame: 4 nights (approximately 32 hours)
Maternal skin pressure distribution abdomen
Averaged nightly mean pressure, in pounds per square inch (PSI), in the abdominal region.
Time frame: 4 nights (approximately 32 hours)
Maternal skin pressure distribution pelvis
Averaged nightly mean pressure, in pounds per square inch (PSI), in the pelvic region.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 nights (approximately 32 hours)
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