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Sleep Position Pattern Recording

Status

Not yet enrolling

Conditions

Pregnant Women

Treatments

Device: Skiin Garment system

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06286904
McMaster-Myant 16633

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial design

52 participants in 1 patient group

Sleep position detection
Description:
Accuracy of Skiin Garment system for detecting sleep position of pregnant womem.
Treatment:
Device: Skiin Garment system

Trial contacts and locations

1

There are currently no registered sites for this trial.

Central trial contact

Kyle Mcgowan; Eran Ashwal

Timeline

Last updated: Mar 01, 2024

Start date

Apr 01, 2024 • 1 year and 1 month ago

End date

Dec 01, 2024 • 5 months ago

Today

May 12, 2025

Sponsors of this trial

Lead Sponsor

Collaborating Sponsor

Data sourced from clinicaltrials.gov