Pregnancy RelatedSLeeP AID4NCT05376475
Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders
An observational study of Pregnancy Related and Sleep, run by Shiphrah Biomedical Inc. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Sleep, Sleep-Disordered Breathing
- What is being tested?
- Infrared video-audio camera, Level III home sleep apnea test and Maternal-fetal transabdominal electrocardiographic heart rate monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jul 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Pregnant persons with singleton pregnancies in their third trimester living in Canada and their bed partner (if applicable).
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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Toronto
Toronto, Ontario, M5G 1L5
Elham Dolatabadi, PhD
Elham Dolatabadi, PhD
About this study
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
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.
- Being tested
- Infrared video-audio camera, Level III home sleep apnea test, Maternal-fetal transabdominal electrocardiographic heart rate monitor, Pressure sensing mat
- Medical subject headings
- Sleep Apnea Syndromes, Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared video-audio cameraDevice
Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA
Level III home sleep apnea testDevice
NightOwl® by Ectosense, Leuven, Belgium
Maternal-fetal transabdominal electrocardiographic heart rate monitorDevice
The Monica AN24 Antenatal Fetal Holter by Monica Healthcare, Nottingham, UK
Pressure sensing matDevice
Tactilus® V Series Mattress Pressure Monitoring System by Sensor Products Inc., Madison, USA
| Study group | Role | What they receive |
|---|---|---|
| Virtual setup cohort | 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. Receives: Device: Infrared video-audio camera; Device: Level III home sleep apnea test | |
| In-person setup cohort | 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). Receives: Device: Infrared video-audio camera; Device: Level III home sleep apnea test; Device: Maternal-fetal transabdominal electrocardiographic heart rate monitor; Device: Pressure sensing mat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal supine sleep position
Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video.
Measured: 4 nights (approximately 32 hours)
Secondary outcomes (45)
Bed partner sleep position
Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video.
Measured: 4 nights (approximately 32 hours)
Maternal obstructive sleep apnea
Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.
Measured: 4 nights (approximately 32 hours)
Bed partner obstructive sleep apnea
Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.
Measured: 4 nights (approximately 32 hours)
Maternal limb movements
Average nightly periodic limb movement index (number of limb movements per hour)
Measured: 4 nights (approximately 32 hours)
Bed partner limb movements
Average nightly periodic limb movement index (number of limb movements per hour)
Measured: 4 nights (approximately 32 hours)
Maternal restless legs syndrome
Present or absent, as determined by participant self report.
Measured: 4 nights (approximately 32 hours)
Bed partner restless legs syndrome
Present or absent, as determined by participant self report.
Measured: 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.
Measured: 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.
Measured: 4 nights (approximately 32 hours)
Maternal time in bed (TIB)
Average nightly total time the participant is in bed.
Measured: 4 nights (approximately 32 hours)
Bed partner time in bed (TIB)
Average nightly total time the participant is in bed.
Measured: 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%).
Measured: 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%).
Measured: 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.
Measured: 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.
Measured: 4 nights (approximately 32 hours)
Maternal snoring
Present or absent as determined by manual review of audio from infrared video.
Measured: 4 nights (approximately 32 hours)
Bed partner snoring
Present or absent as determined by manual review of audio from infrared video.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 4 nights (approximately 32 hours)
Maternal skin pressure distribution thorax
Averaged nightly mean pressure, in pounds per square inch (PSI), in the thorax region.
Measured: 4 nights (approximately 32 hours)
Maternal skin pressure distribution abdomen
Averaged nightly mean pressure, in pounds per square inch (PSI), in the abdominal region.
Measured: 4 nights (approximately 32 hours)
Maternal skin pressure distribution pelvis
Averaged nightly mean pressure, in pounds per square inch (PSI), in the pelvic region.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 nights (approximately 32 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start6 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiphrah Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mitacs, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Elham Dolatabadi, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376475
- Sponsor's protocol ID
- SBI-007
- Acronym
- SLeeP AID4
- Status last verified
- Oct 2022
- First submitted
- 12 May 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Participants' study data will not be released outside of the study team without the written permission of the participant, except as necessary for duty to report or force of law (i.e., by subpoena). Study data will not be made open access.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05376475
- Acronym / sponsor ID
- SLeeP AID4 / SBI-007
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shiphrah Biomedical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mitacs, University of Toronto
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual setup cohort | – | Device: Infrared video-audio camera, Device: Level III home sleep apnea testParticipants 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. |
| In-person setup cohort | – | Device: Infrared video-audio camera, Device: Level III home sleep apnea test, Device: Maternal-fetal transabdominal electrocardiographic heart rate monitor, Device: Pressure sensing matParticipants 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant persons with singleton pregnancies in their third trimester living in Canada and their bed partner (if applicable).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared video-audio cameraWyze Cam V2 by Wyze Labs, Inc., Seattle, USA | Device | In-person setup cohort, Virtual setup cohort |
| Level III home sleep apnea testNightOwl® by Ectosense, Leuven, Belgium | Device | In-person setup cohort, Virtual setup cohort |
| Maternal-fetal transabdominal electrocardiographic heart rate monitorThe Monica AN24 Antenatal Fetal Holter by Monica Healthcare, Nottingham, UK | Device | In-person setup cohort |
| Pressure sensing matTactilus® V Series Mattress Pressure Monitoring System by Sensor Products Inc., Madison, USA | Device | In-person setup cohort |
Primary outcome
Maternal supine sleep position
Time frame: 4 nights (approximately 32 hours)
Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video.
45 secondary outcomes
Bed partner sleep position
Time frame: 4 nights (approximately 32 hours)
Maternal obstructive sleep apnea
Time frame: 4 nights (approximately 32 hours)
Bed partner obstructive sleep apnea
Time frame: 4 nights (approximately 32 hours)
Maternal limb movements
Time frame: 4 nights (approximately 32 hours)
Bed partner limb movements
Time frame: 4 nights (approximately 32 hours)
Maternal restless legs syndrome
Time frame: 4 nights (approximately 32 hours)
Bed partner restless legs syndrome
Time frame: 4 nights (approximately 32 hours)
Maternal total sleep time (TST)
Time frame: 4 nights (approximately 32 hours)
Bed partner total sleep time (TST)
Time frame: 4 nights (approximately 32 hours)
Maternal time in bed (TIB)
Time frame: 4 nights (approximately 32 hours)
Bed partner time in bed (TIB)
Time frame: 4 nights (approximately 32 hours)
Maternal sleep efficiency
Time frame: 4 nights (approximately 32 hours)
Bed partner sleep efficiency
Time frame: 4 nights (approximately 32 hours)
Maternal rapid eye movement (REM) sleep duration
Time frame: 4 nights (approximately 32 hours)
Bed partner rapid eye movement (REM) sleep duration
Time frame: 4 nights (approximately 32 hours)
Maternal snoring
Time frame: 4 nights (approximately 32 hours)
Bed partner snoring
Time frame: 4 nights (approximately 32 hours)
Minimum maternal heart rate (HR)
Time frame: 4 nights (approximately 32 hours)
Minimum maternal respiration rate (RR)
Time frame: 4 nights (approximately 32 hours)
Minimum bed partner respiration rate (RR)
Time frame: 4 nights (approximately 32 hours)
Minimum bed partner heart rate (HR)
Time frame: 4 nights (approximately 32 hours)
Minimum maternal peripheral blood oxygen saturation (SpO2)
Time frame: 4 nights (approximately 32 hours)
Minimum bed partner peripheral blood oxygen saturation (SpO2)
Time frame: 4 nights (approximately 32 hours)
Maximum maternal heart rate (HR)
Time frame: 4 nights (approximately 32 hours)
Maximum bed partner heart rate (HR)
Time frame: 4 nights (approximately 32 hours)
Maximum maternal respiration rate (RR)
Time frame: 4 nights (approximately 32 hours)
Maximum bed partner respiration rate (RR)
Time frame: 4 nights (approximately 32 hours)
Maximum maternal peripheral blood oxygen saturation (SpO2)
Time frame: 4 nights (approximately 32 hours)
Maximum bed partner peripheral blood oxygen saturation (SpO2)
Time frame: 4 nights (approximately 32 hours)
Average maternal heart rate (HR)
Time frame: 4 nights (approximately 32 hours)
Average bed partner heart rate (HR)
Time frame: 4 nights (approximately 32 hours)
Average maternal respiration rate (RR)
Time frame: 4 nights (approximately 32 hours)
Average bed partner respiration rate (RR)
Time frame: 4 nights (approximately 32 hours)
Average maternal peripheral blood oxygen saturation (SpO2)
Time frame: 4 nights (approximately 32 hours)
Average bed partner peripheral blood oxygen saturation (SpO2)
Time frame: 4 nights (approximately 32 hours)
Maternal heart rate variability - root mean square of successive differences
Time frame: 4 nights (approximately 32 hours)
Fetal heart rate variability - root mean square of successive differences
Time frame: 4 nights (approximately 32 hours)
Maternal heart rate variability - standard deviation of NN intervals
Time frame: 4 nights (approximately 32 hours)
Fetal heart rate variability - standard deviation of NN intervals
Time frame: 4 nights (approximately 32 hours)
Maternal skin pressure distribution thorax
Time frame: 4 nights (approximately 32 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No. Participants' study data will not be released outside of the study team without the written permission of the participant, except as necessary for duty to report or force of law (i.e., by subpoena). Study data will not be made open access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham Dolatabadi, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Sleep, run by Shiphrah Biomedical Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Lead ((416) 360-4000, al731156@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal supine sleep position (time frame: 4 nights (approximately 32 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.