Sleep Position Pattern Recording

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnant Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sleep position detection

Accuracy of Skiin Garment system for detecting sleep position of pregnant womem.

Skiin Garment system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes