Sleep Position Pattern Recording

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnant Women
• Intervention / Treatment: Device: Skiin Garment system

Detailed Description

Individuals who are eligible to the study and provided consent to participate will be asked to:

1. Wear the Skiin Garment system for the duration of their time in the hospital (minimum 1 nights until they are discharged from hospital).
2. 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 Type: Observational
• Enrollment (Estimated): 52

Contacts and Locations

• Study Contact: Name: Eran Ashwal; Phone Number: 21334 905.521.2100; Email: eran.ashwal@mcmaster.ca
• Study Contact Backup: Name: Kyle McGowan; Phone Number: 21334 905.521.2100; Email: mcgowank@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University
      • Contact: Kyle McGowan; Phone Number: 21334 905.521.2100; Email: mcgowank@mcmaster.ca
      • Principal Investigator: Eran Ashwal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sleep position detection; Accuracy of Skiin Garment system for detecting sleep position of pregnant womem.	Device: Skiin Garment system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From the beginning to the end of participation, up to 1 year.
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.	One time point, on the morning after one night wearing the Skiin Garment system

Collaborators and Investigators

• Sponsor: Myant Medical Corp.
• Collaborators: McMaster University
• Investigators: Principal Investigator: Eran Ashwal, McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: sleep; Posture; Pregnant Women; wearable electronic devices
• Other Study ID Numbers: McMaster-Myant 16633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No