Clinical trial NCT05376475: Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Sleep
Sleep-Disordered Breathing
Sleep Disturbance
Sleep Disorder
Lead sponsor: Shiphrah Biomedical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mitacs
name: University of Toronto
First posted: 2022-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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) Exclusion Criteria:

* Non-English speaking, reading, or writing
* ASA-PS class III or greater

Primary outcomes:
measure: Maternal supine sleep position
timeFrame: 4 nights (approximately 32 hours)
Secondary outcomes:
measure: Bed partner sleep position
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal obstructive sleep apnea
timeFrame: 4 nights (approximately 32 hours)
measure: Bed partner obstructive sleep apnea
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal limb movements
timeFrame: 4 nights (approximately 32 hours)
measure: Bed partner limb movements
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal restless legs syndrome
timeFrame: 4 nights (approximately 32 hours)
measure: Bed partner restless legs syndrome
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal total sleep time (TST)
timeFrame: 4 nights (approximately 32 hours)
measure: Bed partner total sleep time (TST)
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal time in bed (TIB)
timeFrame: 4 nights (approximately 32 hours)
measure: Bed partner time in bed (TIB)
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal sleep efficiency
timeFrame: 4 nights (approximately 32 hours)
measure: Bed partner sleep efficiency
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal rapid eye movement (REM) sleep duration
timeFrame: 4 nights (approximately 32 hours)
measure: Bed partner rapid eye movement (REM) sleep duration
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal snoring
timeFrame: 4 nights (approximately 32 hours)
measure: Bed partner snoring
timeFrame: 4 nights (approximately 32 hours)
measure: Minimum maternal heart rate (HR)
timeFrame: 4 nights (approximately 32 hours)
measure: Minimum maternal respiration rate (RR)
timeFrame: 4 nights (approximately 32 hours)
measure: Minimum bed partner respiration rate (RR)
timeFrame: 4 nights (approximately 32 hours)
measure: Minimum bed partner heart rate (HR)
timeFrame: 4 nights (approximately 32 hours)
measure: Minimum maternal peripheral blood oxygen saturation (SpO2)
timeFrame: 4 nights (approximately 32 hours)
measure: Minimum bed partner peripheral blood oxygen saturation (SpO2)
timeFrame: 4 nights (approximately 32 hours)
measure: Maximum maternal heart rate (HR)
timeFrame: 4 nights (approximately 32 hours)
measure: Maximum bed partner heart rate (HR)
timeFrame: 4 nights (approximately 32 hours)
measure: Maximum maternal respiration rate (RR)
timeFrame: 4 nights (approximately 32 hours)
measure: Maximum bed partner respiration rate (RR)
timeFrame: 4 nights (approximately 32 hours)
measure: Maximum maternal peripheral blood oxygen saturation (SpO2)
timeFrame: 4 nights (approximately 32 hours)
measure: Maximum bed partner peripheral blood oxygen saturation (SpO2)
timeFrame: 4 nights (approximately 32 hours)
measure: Average maternal heart rate (HR)
timeFrame: 4 nights (approximately 32 hours)
measure: Average bed partner heart rate (HR)
timeFrame: 4 nights (approximately 32 hours)
measure: Average maternal respiration rate (RR)
timeFrame: 4 nights (approximately 32 hours)
measure: Average bed partner respiration rate (RR)
timeFrame: 4 nights (approximately 32 hours)
measure: Average maternal peripheral blood oxygen saturation (SpO2)
timeFrame: 4 nights (approximately 32 hours)
measure: Average bed partner peripheral blood oxygen saturation (SpO2)
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal heart rate variability - root mean square of successive differences
timeFrame: 4 nights (approximately 32 hours)
measure: Fetal heart rate variability - root mean square of successive differences
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal heart rate variability - standard deviation of NN intervals
timeFrame: 4 nights (approximately 32 hours)
measure: Fetal heart rate variability - standard deviation of NN intervals
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal skin pressure distribution thorax
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal skin pressure distribution abdomen
timeFrame: 4 nights (approximately 32 hours)
measure: Maternal skin pressure distribution pelvis
timeFrame: 4 nights (approximately 32 hours)
measure: Average fetal heart rate (FHR)
timeFrame: 4 nights (approximately 32 hours)
measure: Minimum fetal heart rate (FHR)
timeFrame: 4 nights (approximately 32 hours)
measure: Maximum fetal heart rate (FHR)
timeFrame: 4 nights (approximately 32 hours)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Elham Dolatabadi, PhD
role: PRINCIPAL_INVESTIGATOR
References: