An observational study in Pregnant Women, sponsored by Myant Medical Corp.. Not yet recruiting at 1 site in Canada. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Myant Medical Corp. · Observational
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.
Individuals who are eligible to the study and provided consent to participate will be asked to:
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.
Myant Medical Corp. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women admitted in the antenatal in-patient clinic at McMaster University Medical Centre for greater than 24 hours.
Exclusion Criteria:
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.
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.
Time frame: Recorded during the night, during 6 to 8 hours.
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.
Time frame: 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.
Time frame: 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.
Time frame: From the beginning to the end of participation, up to 1 year.
Plan to share: No
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This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Myant Medical Corp.