An interventional study of Oura Ring (Photoplethysmography-based wearable ring) and EmbracePlus Watch (Electrodermal activity wristband sensor) in Perinatal Depression, sponsored by Women's College Hospital. Not yet recruiting at 1 site in Canada. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Women's College Hospital · Not applicable, Interventional, and Device feasibility
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:
Researchers will compare 2 wearable devices, the Oura Ring and EmbracePlus, to see which device provides more complete and usable data.
Participants will:
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.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 10 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Women's College Hospital is the lead sponsor of 87 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants randomized to this arm will wear the Oura Ring continuously from the third trimester of pregnancy through three months postpartum. The device will collect sleep, activity, heart rate, and heart rate variability data passively, alongside daily and biweekly self-report measures.
Device: Oura Ring (Photoplethysmography-based wearable ring)
Participants randomized to this arm will wear the EmbracePlus smartwatch continuously from the third trimester of pregnancy through three months postpartum. The device will collect sleep, activity, heart rate, heart rate variability, and electrodermal activity data passively, alongside daily and biweekly self-report measures.
Device: EmbracePlus Watch (Electrodermal activity wristband sensor)
A lightweight titanium ring worn continuously on the index finger that passively collects sleep, physical activity, heart rate, and heart rate variability data via infrared optical sensors and a 3D accelerometer. Worn throughout the third trimester of pregnancy and three months postpartum to monitor physiological parameters associated with perinatal depression risk.
A medical-grade waterproof smartwatch worn continuously on the wrist that passively collects sleep, physical activity, heart rate, heart rate variability, and electrodermal activity data via photoplethysmography and ventral electrodermal sensors. Worn throughout the third trimester of pregnancy and three months postpartum to monitor physiological parameters associated with perinatal depression risk.
Wearable device adherence completion rate
Feasibility of continuous wearable device data collection will be assessed by the proportion of scheduled data points completed during continuous daily wear. Wearable use profiles will be categorized as low, moderate, or high based on continuous daily wear without interruptions of more than 3 hours. Feasibility will be established if ≥ 70% of scheduled data points are completed across the study period.
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Daily Visual Analogue Scale mood entry completion rate
Feasibility of daily mood self-reporting will be assessed by the proportion of scheduled Visual Analogue Scale mood entries completed by participants. The Visual Analogue Scale is a 100-point scale (range: 0-100), where higher scores indicate better mood. Feasibility will be established if ≥ 70% of scheduled entries are completed across the study period.
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Edinburgh Postnatal Depression Scale completion rate
Feasibility of biweekly depression screening will be assessed by the proportion of scheduled Edinburgh Postnatal Depression Scale surveys completed. The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item questionnaire (range: 0-30), where higher scores indicate greater severity of depressive symptoms. Feasibility will be established if ≥ 70% of scheduled surveys are completed across the study period.
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Generalized Anxiety Disorder-7 completion rate
Feasibility of biweekly anxiety screening will be assessed by the proportion of scheduled Generalized Anxiety Disorder-7 surveys completed. The Generalized Anxiety Disorder-7 is a 7-item questionnaire (range: 0-21), where higher scores indicate greater severity of anxiety symptoms. Feasibility will be established if ≥ 70% of scheduled surveys are completed across the study period.
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Wearable device acceptability among participants (quantitative)
Acceptability of the wearable device will be assessed through a questionnaire administered to participants at study completion. Questions will evaluate comfort, ease of use, perceived burden, satisfaction with the device, and willingness to continue use in a larger study. All questions will be rated from 0-5 (0 being strongly disagree, 3 being neutral, 5 being strongly agree)
Time frame: At 3 months postpartum (end of study)
Wearable device acceptability among participants (qualitative)
Acceptability the wearable device will be assessed through semi-structured interviews administered to participants at study completion. Questions will evaluate comfort, ease of use, perceived burden, satisfaction with the device, and willingness to continue use in a larger study using thematic analysis.
Time frame: At 3 months postpartum (end of study)
Wearable device usability among participants
Usability of the wearable device will be assessed through the System Usability Scale (SUS) administered to participants at study completion. Questions will evaluate comfort and ease of use the device on a 5 point scale (0- strongly disagree, 3- neutral, 5-strongly agree).
Time frame: At 3 months postpartum (end of study)
Wearable device acceptability and integration from the clinician perspective
Clinician acceptability will be assessed through questionnaires and interviews conducted during the study period, evaluating views on wearable technology, potential integration of device-derived data into electronic medical records, and feasibility of incorporating wearable monitoring into routine perinatal care workflows. (Usability of the device will be rated on a likert scale: Strongly disagree (1) to Strongly agree (5))
Time frame: Throughout the study period, up to 3 months postpartum
Participant recruitment
Recruitment feasibility will be defined as successful enrollment of 10 eligible pregnant participants.
Time frame: up to 56 weeks from the recruitment start date
Participant retention
Retention will be considered successful if ≥ 80% of enrolled participants complete follow-up through 3 months postpartum. Reasons for dropout or discontinuation will be recorded.
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between sleep duration and depression symptom severity
Correlation between sleep duration (hours/night, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between physical activity and depression symptom severity
Correlation between physical activity (steps/day, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate and depression symptom severity
Correlation between resting heart rate (beats per minute, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate variability and depression symptom severity
Correlation between heart rate variability (RMSSD, ms, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between physical activity and daily mood
Correlation between physical activity (steps/day, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate and daily mood
Correlation between resting heart rate (beats per minute, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate variability and daily mood
Correlation between heart rate variability (RMSSD, ms, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Comparison of data completeness between wearable devices
Comparison of data completeness (% of expected data points successfully recorded) between the two wearable devices across the study period.
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
Comparison of data quality between wearable devices
Comparison of data quality (% of recorded data points meeting acceptable signal quality thresholds) between the two wearable devices across the study period.
Time frame: From enrollment (13-27 weeks gestation) through 3 months postpartum
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — This is a small feasibility study enrolling 10 participants. Given the limited sample size, the sensitive nature of personal biometrics and questionnaire data, and the requirement to store data on hospital-based servers in accordance with national personal health information legislation, individual participant data will not be shared in order to protect participant confidentiality and privacy.
Start is estimated for Sep 2026; primary completion for Nov 2027, 14 months later.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 14 months is below that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Women's College Hospital