Sleep Position Pattern Recording - A Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Accuracy of Skiin Garment system for detecting sleep position of pregnant women
研究概览
简要总结
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.
详细描述
Individuals who are eligible to the study and provided consent to participate will be asked to:
- Wear the Skiin Garment system for the duration of their time in the hospital (minimum 1 nights until they are discharged from hospital).
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Accuracy of Skiin Garment system for detecting sleep position of pregnant women
时间窗: Recorded during the night, during 6 to 8 hours.
Sleep position will be identified through the Skiin Garment system via accelerometry, and compared to visual confirmation of sleep position.
次要结局
- 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.)