๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-21

Early Detection of Perinatal Depression With Wearable Technology (NCT07784244)

Biometrics in Longitudinal Uptake for Early Monitoring and Assessing Perinatal Patterns of Emotions in Depression

๐ŸŸก Not Yet Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Women's College Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this feasibility study is to learn whether wearable devices and self-report surveys can help researchers better understand changes in mood during pregnancy and after birth in young pregnant individuals with a history of major depressive disorder. The study will also examine whether this type of monitoring is practical and acceptable for participants and clinicians. The main questions it aims to answer are: * Can researchers successfully collect wearable and survey data throughout late pregnancy and the first 3 months after birth? * Do participants and clinicians find wearable-based monitoring easy to use and helpful? * Are changes in sleep, heart rate, activity, and other wearable data linked to mood changes during the perinatal period? Researchers will compare 2 wearable devices, the Oura Ring and EmbracePlus, to see which device provides more complete and usable data. Participants will: * Wear either the Oura Ring or EmbracePlus device every day from the third trimester of pregnancy until 3 months after birth * Complete short daily and biweekly questionnaires about mood and wellbeing * Allow the wearable device to collect information such as sleep, heart rate, heart rate variability, and physical activity The study will include 10 participants. Researchers will measure feasibility by looking at how many participants join the study and how much study data is completed. The study team hopes at least 70% of scheduled study activities data will be collected. Researchers will also interview 5 participants and 4 reproductive psychiatry clinicians about their experiences using wearable monitoring. These interviews will explore ease of use, usefulness in clinical care, and how wearable data may fit into electronic medical records. This study may help researchers develop future tools that can predict the risk of perinatal depression earlier and support more personalized care during pregnancy and after birth.

Who can join: Review the eligibility criteria below.

Location: Women's College Hospital โ€” Toronto, Ontario

Age range: 16 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Women's College Hospital โ€” Toronto, Ontario

๐Ÿ“ž Contact the Study Coordinator

Phone: (416) 323-6400

Email: blanca.boleaalamanac@wchospital.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—