이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Early Detection of Perinatal Depression With Wearable Technology (BLUESMAPPED)

2026년 8월 21일 업데이트: Women's College Hospital

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

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

10

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • Age ≥ 16 years
  • Pregnant, 13-27 weeks gestation at enrollment
  • Previous diagnosis of major depressive disorder (MDD), confirmed by Mini International Neuropsychiatric Interview (MINI) (not necessarily perinatal onset)
  • Currently in remission (EPDS score < 9)
  • Access to a smartphone and internet, or willingness to use a study-provided device

Exclusion Criteria:

  • Active alcohol or substance use disorder within the past 12 months
  • Active suicidal ideation
  • History of bipolar disorder or primary psychotic disorder
  • Physical condition preventing use of Oura Ring or EmbracePlus (expected to be rare)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 장치 타당성
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Oura Ring
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.
장치: Oura Ring (Photoplethysmography-based wearable ring)
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.
활성 비교기: EmbracePlus
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.
장치: EmbracePlus Watch (Electrodermal activity wristband sensor)
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Wearable device adherence completion rate
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
From enrollment (13-27 weeks gestation) through 3 months postpartum
Daily Visual Analogue Scale mood entry completion rate
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
From enrollment (13-27 weeks gestation) through 3 months postpartum
Edinburgh Postnatal Depression Scale completion rate
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
From enrollment (13-27 weeks gestation) through 3 months postpartum
Generalized Anxiety Disorder-7 completion rate
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
From enrollment (13-27 weeks gestation) through 3 months postpartum

2차 결과 측정

결과 측정
측정값 설명
기간
Wearable device acceptability among participants (quantitative)
기간: At 3 months postpartum (end of study)
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)
At 3 months postpartum (end of study)
Wearable device acceptability among participants (qualitative)
기간: At 3 months postpartum (end of study)
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.
At 3 months postpartum (end of study)
Wearable device usability among participants
기간: At 3 months postpartum (end of study)
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).
At 3 months postpartum (end of study)
Wearable device acceptability and integration from the clinician perspective
기간: Throughout the study period, up to 3 months postpartum
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))
Throughout the study period, up to 3 months postpartum
Participant recruitment
기간: up to 56 weeks from the recruitment start date
Recruitment feasibility will be defined as successful enrollment of 10 eligible pregnant participants.
up to 56 weeks from the recruitment start date
Participant retention
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
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.
From enrollment (13-27 weeks gestation) through 3 months postpartum

기타 결과 측정

결과 측정
측정값 설명
기간
Correlation between sleep duration and depression symptom severity
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between sleep duration (hours/night, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).
From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between physical activity and depression symptom severity
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between physical activity (steps/day, recorded by wearable device) and depression symptom severity (total score on the Edinburgh Postnatal Depression Scale, 0-30).
From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate and depression symptom severity
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
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).
From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate variability and depression symptom severity
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
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).
From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between physical activity and daily mood
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between physical activity (steps/day, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).
From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate and daily mood
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between resting heart rate (beats per minute, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).
From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate variability and daily mood
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
Correlation between heart rate variability (RMSSD, ms, recorded by wearable device) and daily mood (score on a visual analogue scale, 0-100).
From enrollment (13-27 weeks gestation) through 3 months postpartum
Comparison of data completeness between wearable devices
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
Comparison of data completeness (% of expected data points successfully recorded) between the two wearable devices across the study period.
From enrollment (13-27 weeks gestation) through 3 months postpartum
Comparison of data quality between wearable devices
기간: From enrollment (13-27 weeks gestation) through 3 months postpartum
Comparison of data quality (% of recorded data points meeting acceptable signal quality thresholds) between the two wearable devices across the study period.
From enrollment (13-27 weeks gestation) through 3 months postpartum

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Women's College Hospital

협력자

University of Toronto
Canada Foundation for Innovation

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 11월 1일

연구 완료 (추정된)

2027년 11월 1일

연구 등록 날짜

최초 제출

2026년 6월 1일

QC 기준을 충족하는 최초 제출

2026년 8월 21일

처음 게시됨 (실제)

2026년 8월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 21일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-0085-E
  • 12345 (기타 보조금/기금 번호: Reasons for Hope Fund in Prevention and Early Detection of Mental Illness)
  • 39923 (기타 보조금/기금 번호: Canada Foundation for Innovation)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다