NCT06286904

Sleep Position Pattern Recording

Sleep Position Pattern Recording - A Validation Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 52 (estimated)
• Sponsor: Myant Medical Corp. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pregnant Women

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-12-01
• Completion: 2025-03-30
• First posted: 2024-02-29
• Last updated: 2024-03-01

Locations

1 site across 1 country: Canada