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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy Related, Sleep, Sleep-Disordered Breathing, Sleep Disturbance, Sleep Disorder

Intervention / Treatment
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* Device: Infrared video-audio camera
* Device: Level III home sleep apnea test
* Device: Maternal-fetal transabdominal electrocardiographic heart rate monitor
* Device: Pressure sensing mat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Virtual setup cohort<br>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<br>* Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA<br>Device: Level III home sleep apnea test<br>* NightOwl® by Ectosense, Leuven, Belgium<br>|
| In-person setup cohort<br>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<br>* Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA<br>Device: Level III home sleep apnea test<br>* NightOwl® by Ectosense, Leuven, Belgium<br>Device: Maternal-fetal transabdominal electrocardiographic heart rate monitor<br>* The Monica AN24 Antenatal Fetal Holter by Monica Healthcare, Nottingham, UK<br>Device: Pressure sensing mat<br>* Tactilus® V Series Mattress Pressure Monitoring System by Sensor Products Inc., Madison, USA<br>|

What is the study measuring?
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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) |