Pregnancy Related, Sleep, Sleep Disorder, Sleep-Disordered Breathing, Sleep Disturbance
Conditions
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.
Interventions
DEVICELevel III home sleep apnea test
NightOwl® by Ectosense, Leuven, Belgium
DEVICEInfrared video-audio camera
Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA
DEVICEMaternal-fetal transabdominal electrocardiographic heart rate monitor
The Monica AN24 Antenatal Fetal Holter by Monica Healthcare, Nottingham, UK
DEVICEPressure sensing mat
Tactilus® V Series Mattress Pressure Monitoring System by Sensor Products Inc., Madison, USA
Sponsors
Mitacs
University of Toronto
Shiphrah Biomedical Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal supine sleep position | 4 nights (approximately 32 hours) | Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bed partner sleep position | 4 nights (approximately 32 hours) | Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video. |
| Maternal obstructive sleep apnea | 4 nights (approximately 32 hours) | Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test. |
| Bed partner obstructive sleep apnea | 4 nights (approximately 32 hours) | Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test. |
| Maternal limb movements | 4 nights (approximately 32 hours) | Average nightly periodic limb movement index (number of limb movements per hour) |
| Bed partner limb movements | 4 nights (approximately 32 hours) | Average nightly periodic limb movement index (number of limb movements per hour) |
| Maternal restless legs syndrome | 4 nights (approximately 32 hours) | Present or absent, as determined by participant self report. |
| Bed partner restless legs syndrome | 4 nights (approximately 32 hours) | Present or absent, as determined by participant self report. |
| Maternal total sleep time (TST) | 4 nights (approximately 32 hours) | Average nightly total sleep time in minutes as determined by the home-sleep apnea monitor. |
| Bed partner total sleep time (TST) | 4 nights (approximately 32 hours) | Average nightly total sleep time in minutes as determined by the home-sleep apnea monitor. |
| Maternal time in bed (TIB) | 4 nights (approximately 32 hours) | Average nightly total time the participant is in bed. |
| Bed partner time in bed (TIB) | 4 nights (approximately 32 hours) | Average nightly total time the participant is in bed. |
| Maternal sleep efficiency | 4 nights (approximately 32 hours) | Average nightly percentage of total time in bed spent sleeping (ratio of TST to TIB multiplied by 100%). |
| Bed partner sleep efficiency | 4 nights (approximately 32 hours) | Average nightly percentage of total time in bed spent sleeping (ratio of TST to TIB multiplied by 100%). |
| Maternal rapid eye movement (REM) sleep duration | 4 nights (approximately 32 hours) | Average nightly time of REM sleep in minutes as determined by the home-sleep apnea monitor. |
| Bed partner rapid eye movement (REM) sleep duration | 4 nights (approximately 32 hours) | Average nightly time of REM sleep in minutes as determined by the home-sleep apnea monitor. |
| Maternal snoring | 4 nights (approximately 32 hours) | Present or absent as determined by manual review of audio from infrared video. |
| Bed partner snoring | 4 nights (approximately 32 hours) | Present or absent as determined by manual review of audio from infrared video. |
| Minimum maternal heart rate (HR) | 4 nights (approximately 32 hours) | Averaged nightly minimum HR, in beats per minute, as determined by the home-sleep apnea monitor. |
| Minimum maternal respiration rate (RR) | 4 nights (approximately 32 hours) | Averaged nightly minimum, in breaths per minute, as determined by manual review of audio and video from the infrared video data. |
| Minimum bed partner respiration rate (RR) | 4 nights (approximately 32 hours) | Averaged nightly minimum, in breaths per minute, as determined by manual review of audio and video from the infrared video data. |
| Minimum maternal peripheral blood oxygen saturation (SpO2) | 4 nights (approximately 32 hours) | Averaged nightly minimum, in percent, as determined by the home-sleep apnea monitor. |
| Minimum bed partner peripheral blood oxygen saturation (SpO2) | 4 nights (approximately 32 hours) | Averaged nightly minimum, in percent, as determined by the home-sleep apnea monitor. |
| Maximum maternal heart rate (HR) | 4 nights (approximately 32 hours) | Averaged nightly maximum HR, in beats per minute, as determined by the home-sleep apnea monitor. |
| Maximum bed partner heart rate (HR) | 4 nights (approximately 32 hours) | Averaged nightly maximum HR, in beats per minute, as determined by the home-sleep apnea monitor. |
| Maximum maternal respiration rate (RR) | 4 nights (approximately 32 hours) | Averaged nightly maximum, in breaths per minute, as determined by manual review of audio and video from the infrared video data. |
| Maximum bed partner respiration rate (RR) | 4 nights (approximately 32 hours) | Averaged nightly maximum, in breaths per minute, as determined by manual review of audio and video from the infrared video data. |
| Maximum maternal peripheral blood oxygen saturation (SpO2) | 4 nights (approximately 32 hours) | Averaged nightly maximum, in percent, as determined by the home-sleep apnea monitor. |
| Maximum bed partner peripheral blood oxygen saturation (SpO2) | 4 nights (approximately 32 hours) | Averaged nightly maximum, in percent, as determined by the home-sleep apnea monitor. |
| Average maternal heart rate (HR) | 4 nights (approximately 32 hours) | Averaged nightly mean HR, in beats per minute, as determined by the home-sleep apnea monitor. |
| Average bed partner heart rate (HR) | 4 nights (approximately 32 hours) | Averaged nightly mean HR, in beats per minute, as determined by the home-sleep apnea monitor. |
| Average maternal respiration rate (RR) | 4 nights (approximately 32 hours) | Averaged nightly mean, in breaths per minute, as determined by manual review of audio and video from the infrared video data. |
| Average bed partner respiration rate (RR) | 4 nights (approximately 32 hours) | Averaged nightly mean, in breaths per minute, as determined by manual review of audio and video from the infrared video data. |
| Average maternal peripheral blood oxygen saturation (SpO2) | 4 nights (approximately 32 hours) | Averaged nightly mean, in percent, as determined by the home-sleep apnea monitor. |
| Average bed partner peripheral blood oxygen saturation (SpO2) | 4 nights (approximately 32 hours) | Averaged nightly mean, in percent, as determined by the home-sleep apnea monitor. |
| Maternal heart rate variability - root mean square of successive differences | 4 nights (approximately 32 hours) | Averaged nightly beat-to-beat variation as measured by the root mean square of successive differences (RMSSD). |
| Fetal heart rate variability - root mean square of successive differences | 4 nights (approximately 32 hours) | Averaged nightly beat-to-beat variation as measured by the root mean square of successive differences (RMSSD). |
| Maternal heart rate variability - standard deviation of NN intervals | 4 nights (approximately 32 hours) | Averaged nightly beat-to-beat variation as measured by the standard deviation of N-N intervals (SDNN). |
| Fetal heart rate variability - standard deviation of NN intervals | 4 nights (approximately 32 hours) | Averaged nightly beat-to-beat variation as measured by the standard deviation of N-N intervals (SDNN). |
| Maternal skin pressure distribution thorax | 4 nights (approximately 32 hours) | Averaged nightly mean pressure, in pounds per square inch (PSI), in the thorax region. |
| Minimum bed partner heart rate (HR) | 4 nights (approximately 32 hours) | Averaged nightly minimum HR, in beats per minute, as determined by the home-sleep apnea monitor. |
| Maternal skin pressure distribution pelvis | 4 nights (approximately 32 hours) | Averaged nightly mean pressure, in pounds per square inch (PSI), in the pelvic region. |
| Average fetal heart rate (FHR) | 4 nights (approximately 32 hours) | Averaged nightly mean FHR, in beats per minute, as determined by the ambulatory maternal-fetal heart rate monitor. |
| Minimum fetal heart rate (FHR) | 4 nights (approximately 32 hours) | Averaged nightly minimum FHR, in beats per minute, as determined by the ambulatory maternal-fetal heart rate monitor. |
| Maximum fetal heart rate (FHR) | 4 nights (approximately 32 hours) | Averaged nightly maximum FHR, in beats per minute, as determined by the ambulatory maternal-fetal heart rate monitor. |
| Maternal skin pressure distribution abdomen | 4 nights (approximately 32 hours) | Averaged nightly mean pressure, in pounds per square inch (PSI), in the abdominal region. |
Countries
Canada
Contacts
Primary ContactResearch Lead
Outcome results
None listed