Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders (SLeeP AID4)

October 26, 2022 updated by: Shiphrah Biomedical Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1L5
        • Recruiting
        • University of Toronto
        • Contact:
          • Elham Dolatabadi, PhD
        • Principal Investigator:
          • Elham Dolatabadi, PhD
        • Sub-Investigator:
          • Sebastian Hobson, PhD
        • Sub-Investigator:
          • Allan Kember, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Infrared video-audio camera
Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA
Device: Level III home sleep apnea test
NightOwl® by Ectosense, Leuven, Belgium
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).
Device: Infrared video-audio camera
Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA
Device: Level III home sleep apnea test
NightOwl® by Ectosense, Leuven, Belgium
Device: Maternal-fetal transabdominal electrocardiographic heart rate monitor
The Monica AN24 Antenatal Fetal Holter by Monica Healthcare, Nottingham, UK
Device: Pressure sensing mat
Tactilus® V Series Mattress Pressure Monitoring System by Sensor Products Inc., Madison, USA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 nights (approximately 32 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bed partner 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.
4 nights (approximately 32 hours)
Maternal obstructive sleep apnea
Time Frame: 4 nights (approximately 32 hours)
Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.
4 nights (approximately 32 hours)
Bed partner obstructive sleep apnea
Time Frame: 4 nights (approximately 32 hours)
Average nightly Apnea-Hypopnea Index as determined by the home-sleep apnea test.
4 nights (approximately 32 hours)
Maternal limb movements
Time Frame: 4 nights (approximately 32 hours)
Average nightly periodic limb movement index (number of limb movements per hour)
4 nights (approximately 32 hours)
Bed partner limb movements
Time Frame: 4 nights (approximately 32 hours)
Average nightly periodic limb movement index (number of limb movements per hour)
4 nights (approximately 32 hours)
Maternal restless legs syndrome
Time Frame: 4 nights (approximately 32 hours)
Present or absent, as determined by participant self report.
4 nights (approximately 32 hours)
Bed partner restless legs syndrome
Time Frame: 4 nights (approximately 32 hours)
Present or absent, as determined by participant self report.
4 nights (approximately 32 hours)
Maternal total sleep time (TST)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
Average nightly total time the participant is in bed.
4 nights (approximately 32 hours)
Bed partner time in bed (TIB)
Time Frame: 4 nights (approximately 32 hours)
Average nightly total time the participant is in bed.
4 nights (approximately 32 hours)
Maternal sleep efficiency
Time Frame: 4 nights (approximately 32 hours)
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
Time Frame: 4 nights (approximately 32 hours)
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
Time Frame: 4 nights (approximately 32 hours)
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
Time Frame: 4 nights (approximately 32 hours)
Average nightly time of REM sleep in minutes as determined by the home-sleep apnea monitor.
4 nights (approximately 32 hours)
Maternal snoring
Time Frame: 4 nights (approximately 32 hours)
Present or absent as determined by manual review of audio from infrared video.
4 nights (approximately 32 hours)
Bed partner snoring
Time Frame: 4 nights (approximately 32 hours)
Present or absent as determined by manual review of audio from infrared video.
4 nights (approximately 32 hours)
Minimum maternal heart rate (HR)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 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.
4 nights (approximately 32 hours)
Minimum bed partner respiration rate (RR)
Time Frame: 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.
4 nights (approximately 32 hours)
Minimum bed partner heart rate (HR)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
Averaged nightly minimum, in percent, as determined by the home-sleep apnea monitor.
4 nights (approximately 32 hours)
Maximum maternal heart rate (HR)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 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.
4 nights (approximately 32 hours)
Maximum bed partner respiration rate (RR)
Time Frame: 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.
4 nights (approximately 32 hours)
Maximum maternal peripheral blood oxygen saturation (SpO2)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
Averaged nightly maximum, in percent, as determined by the home-sleep apnea monitor.
4 nights (approximately 32 hours)
Average maternal heart rate (HR)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 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.
4 nights (approximately 32 hours)
Average bed partner respiration rate (RR)
Time Frame: 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.
4 nights (approximately 32 hours)
Average maternal peripheral blood oxygen saturation (SpO2)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
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
Time Frame: 4 nights (approximately 32 hours)
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
Time Frame: 4 nights (approximately 32 hours)
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
Time Frame: 4 nights (approximately 32 hours)
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
Time Frame: 4 nights (approximately 32 hours)
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
Time Frame: 4 nights (approximately 32 hours)
Averaged nightly mean pressure, in pounds per square inch (PSI), in the thorax region.
4 nights (approximately 32 hours)
Maternal skin pressure distribution abdomen
Time Frame: 4 nights (approximately 32 hours)
Averaged nightly mean pressure, in pounds per square inch (PSI), in the abdominal region.
4 nights (approximately 32 hours)
Maternal skin pressure distribution pelvis
Time Frame: 4 nights (approximately 32 hours)
Averaged nightly mean pressure, in pounds per square inch (PSI), in the pelvic region.
4 nights (approximately 32 hours)
Average fetal heart rate (FHR)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
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)
Time Frame: 4 nights (approximately 32 hours)
Averaged nightly maximum FHR, in beats per minute, as determined by the ambulatory maternal-fetal heart rate monitor.
4 nights (approximately 32 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shiphrah Biomedical Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mitacs
University of Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elham Dolatabadi, PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBI-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings