Sleep Position Pattern Recording

Pregnant Women Clinical Trial

Official title:

Sleep Position Pattern Recording - A Validation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286904
• Other study ID #: McMaster-Myant 16633
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: February 2024
• Source: Myant Medical Corp.
• Contact: Eran Ashwal
• Phone: 905.521.2100
• Email: eran.ashwal[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: March 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Myant Medical Corp.	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.