Pregnant Women Clinical Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Myant Medical Corp. | McMaster University |
Canada,
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. |
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