Pregnant WomenNCT06286904
Sleep Position Pattern Recording
An observational study of Pregnant Women, run by Myant Medical Corp. at 1 site in Canada.
Trial summary
The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Skiin Garment system
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 2 Oct 2026
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women admitted in the antenatal in-patient clinic at McMaster University Medical Centre for greater than 24 hours.
Who may be able to join
- Assigned female at birth
- Currently pregnant
- Admission to MUMC Antenatal Clinic with anticipation of being admitted for greater than 24 hours
- Able and willing to provide informed consent to participate
Who cannot join
- Unestablished gestational dating (based on first-trimester ultrasound)
- Known maternal cardiac or pulmonary disorder
- Known sleep disorders (i.e., sleep apnea, periodic limb movement disorder, etc.)
- Known fetal chromosomal or structural abnormalities
- Known highly sensitive skin/skin sensitivities to textile electrodes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Position Pattern Recording - A Validation Study
The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth.
Read the detailed description
Individuals who are eligible to the study and provided consent to participate will be asked to:
- Wear the Skiin Garment system for the duration of their time in the hospital (minimum 1 nights until they are discharged from hospital).
- Complete a study completion questionnaire about their experience with the device and the study.
The Skiin Garment system is composed by biosensing garments presented in different form factors (bra, chest band, or underwear). It captures physiological metrics and relay information from a pod to local hub with Bluetooth.
The true body position will be obtained using visual observations and cameras.
- Conditions
- Pregnant Women
- Being tested
- Skiin Garment system
- Keywords
- sleep, wearable electronic devices, Pregnant Women, Posture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skiin Garment systemDevice
Individuals will be asked to wear a Skiin Garment system for the duration of their hospitalization (minimum one day).The system will collect accelerometer, ECG, temperature, heart rate, steps and sleep metrics data if enable. Then, they will be asked to answer a questionnaire about their experiences with the device and the study.
| Study group | Role | What they receive |
|---|---|---|
| Sleep position detection | Accuracy of Skiin Garment system for detecting sleep position of pregnant womem. Receives: Device: Skiin Garment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Skiin Garment system for detecting sleep position of pregnant women
Sleep position will be identified through the Skiin Garment system via accelerometry, and compared to visual confirmation of sleep position.
Measured: Recorded during the night, during 6 to 8 hours.
Secondary outcomes (3)
Questionnaire on wearable device invasiveness and satisfaction
Pregnant women will be asked to answer a questionnaire at the end of their participation in the study. It contains questions related to patients' experience wearing the Skiin Garment system, including invasiveness and satisfaction.
This is an ad-hoc questionnaire titled "SPV_Satisfaction_Questionnaire_v1_2023-04-03" containing 20 questions: 14 questions use a Likert scale design, 3 questions are single choice answer, and 3 questions are open-ended questions. Results are not reported as a total score on a scale but descriptive statistics will be used individually per question.
Measured: One time point, on the morning after one night wearing the Skiin Garment system
Participant recruitment rate
Recruitment rate will be calculated as the number of participants who consent to participant divided by the number of participants who consent to be contacted.
Measured: From the beginning to the end of the recruitment, up to 1 year.
Participant retention rate
The retention rate will be calculated as the number of participants who remain in the study divided by the number of participants who initially consent to participate.
Measured: From the beginning to the end of participation, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2024
- Study completion2 Oct 2026 (estimated)
Why it stopped: Funding and regulatory issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myant Medical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Eran Ashwal, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286904
- Sponsor's protocol ID
- McMaster-Myant 16633
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Position Pattern Recording - A Validation Study
- ClinicalTrials.gov ID
- NCT06286904
- Acronym / sponsor ID
- McMaster-Myant 16633
- Conditions
- Pregnant Women
- Keywords
- sleep, wearable electronic devices, Pregnant Women, Posture
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Funding and regulatory issues.
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Myant Medical Corp.Industry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth.
Detailed description
Individuals who are eligible to the study and provided consent to participate will be asked to:
- Wear the Skiin Garment system for the duration of their time in the hospital (minimum 1 nights until they are discharged from hospital).
- Complete a study completion questionnaire about their experience with the device and the study.
The Skiin Garment system is composed by biosensing garments presented in different form factors (bra, chest band, or underwear). It captures physiological metrics and relay information from a pod to local hub with Bluetooth.
The true body position will be obtained using visual observations and cameras.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep position detection | – | Device: Skiin Garment systemAccuracy of Skiin Garment system for detecting sleep position of pregnant womem. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women admitted in the antenatal in-patient clinic at McMaster University Medical Centre for greater than 24 hours.
Key inclusion criteria (4 listed)
- Assigned female at birth
- Currently pregnant
- Admission to MUMC Antenatal Clinic with anticipation of being admitted for greater than 24 hours
- Able and willing to provide informed consent to participate
Key exclusion criteria (5 listed)
- Unestablished gestational dating (based on first-trimester ultrasound)
- Known maternal cardiac or pulmonary disorder
- Known sleep disorders (i.e., sleep apnea, periodic limb movement disorder, etc.)
- Known fetal chromosomal or structural abnormalities
- Known highly sensitive skin/skin sensitivities to textile electrodes
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 |
|---|---|---|
| Skiin Garment systemIndividuals will be asked to wear a Skiin Garment system for the duration of their hospitalization (minimum one day).The system will collect accelerometer, ECG, temperature, heart rate, steps and sleep metrics data if enable. Then, they will be asked to answer a questionnaire about their experiences with the device and the study. | Device | Sleep position detection |
Primary outcome
Accuracy of Skiin Garment system for detecting sleep position of pregnant women
Time frame: Recorded during the night, during 6 to 8 hours.
Sleep position will be identified through the Skiin Garment system via accelerometry, and compared to visual confirmation of sleep position.
3 secondary outcomes
Questionnaire on wearable device invasiveness and satisfaction
Time frame: One time point, on the morning after one night wearing the Skiin Garment system
Participant recruitment rate
Time frame: From the beginning to the end of the recruitment, up to 1 year.
Participant retention rate
Time frame: From the beginning to the end of participation, up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Eran Ashwal principal investigator
McMaster University
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 Pregnant Women, run by Myant Medical Corp. 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?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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: paused, as of the sponsor's last update on 8 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Skiin Garment system for detecting sleep position of pregnant women (time frame: Recorded during the night, during 6 to 8 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 8 Oct 2026.