Sleep Position Pattern Recording

NCT06286904 | Not Yet Recruiting

• 1 other identifier: McMaster-Myant 16633
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnant Women

Keywords

sleep; wearable electronic devices; Pregnant Women; Posture

Outcome Measures

Primary Outcomes (1)

• 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.

  Recorded during the night, during 6 to 8 hours.

Secondary Outcomes (3)

• Questionnaire on wearable device invasiveness and satisfaction

  One time point, on the morning after one night wearing the Skiin Garment system

• Participant recruitment rate

  From the beginning to the end of the recruitment, up to 1 year.

• Participant retention rate

  From the beginning to the end of participation, up to 1 year.

Study Arms (1)

Sleep position detection

Accuracy of Skiin Garment system for detecting sleep position of pregnant womem.

Device: Skiin Garment system

Interventions

Skiin Garment system DEVICE

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.

Sleep position detection

Eligibility Criteria

• Gender Eligibility Details: This study will enroll pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women admitted in the antenatal in-patient clinic at McMaster University Medical Centre for greater than 24 hours.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myant Medical Corp.: lead
• McMaster University: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Study Officials

• Eran Ashwal

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Ashwal

CONTACT

905.521.2100; eran.ashwal@mcmaster.ca

Kyle Mcgowan

CONTACT

905.521.2100; mcgowank@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 29, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 30, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)