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Early Detection of Perinatal Depression With Wearable Technology (BLUESMAPPED)

2026年8月21日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

10

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：デバイスの実現可能性
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.
アクティブコンパレータ：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.
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Wearable device adherence completion rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Wearable device acceptability among participants (quantitative)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Correlation between sleep duration and depression symptom severity
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Women's College Hospital

協力者

University of Toronto
Canada Foundation for Innovation

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年11月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年8月21日

最初の投稿 (実際)

2026年8月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月25日

QC基準を満たした最後の更新が送信されました

2026年8月21日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-0085-E
  • 12345 (その他の助成金/資金番号：Reasons for Hope Fund in Prevention and Early Detection of Mental Illness)
  • 39923 (その他の助成金/資金番号：Canada Foundation for Innovation)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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