Wearable-Based Study of Depression and Sleep in Older Adults

February 9, 2026 updated by: Ta-wei Guu, China Medical University Hospital

Wearable-enhanced Intervention for Elderly Depression and Sleep Disturbance - From Feasibility and Efficacy, to Development of the First Taiwanese Wearable-embedded Elderly Prospective Research Cohort

This 4-year study aims to develop a safe and effective management model for late-life depression using wearable technologies. The research will recruit older adults (aged 60 and above) with major depressive disorder, confirmed by DSM-5 criteria.

In the first phase, participants will wear a research-grade actigraphy device (Geneactiv) for at least four weeks to assess its usability and accuracy compared with traditional questionnaires. In later phases, a double-blind randomized clinical trial will evaluate the efficacy of a photobiomodulation (PBM) headband in improving depressive and sleep symptoms.

The project will also establish Taiwan's first longitudinal database integrating wearable data, clinical symptoms, and biological markers, aiming to identify digital phenotypes and predictive biomarkers for elderly depression. The study is expected to advance precision psychiatry and digital health applications in geriatric mental health care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

By 2025, Taiwan will become a super-aged society, with a rapidly growing number of older adults living with depression and related sleep problems. Late-life depression is often underdiagnosed and undertreated, and current assessments rely heavily on self-reported or clinician-rated questionnaires, which only provide snapshots of symptoms and may not accurately reflect daily variations in mood and sleep. These challenges highlight the urgent need for more objective, continuous, and accessible tools to monitor and manage depression in older adults.

Wearable devices, such as actigraphy and photobiomodulation (PBM), offer new opportunities for both assessment and intervention. Actigraphy can provide objective data on sleep-wake cycles, activity levels, and circadian rhythms, while PBM uses near-infrared light to modulate brain activity and improve mood and sleep quality. Building on our previous collaboration with Harvard University and recent findings from wearable PBM trials, this project seeks to establish an integrated, technology-assisted model for managing late-life depression in Taiwan.

This four-year project will begin by validating the feasibility and acceptability of a research-grade actigraphy device (Geneactiv) among older adults diagnosed with major depressive disorder (MDD). Objective activity and sleep data will be compared with questionnaire-based assessments to evaluate reliability and consistency, forming the foundation for Taiwan's first longitudinal wearable-based geriatric depression database.

In the second and third years, the study will conduct a double-blind, randomized, sham-controlled clinical trial to evaluate the safety and effectiveness of a wearable PBM headband device in improving depressive symptoms and sleep quality. Participants will continue their regular treatments while using the PBM device at home for daily sessions.

In the final year, longitudinal data from actigraphy, PBM intervention, clinical evaluations, and biological markers will be analyzed to identify digital phenotypes and predictive biomarkers associated with depression severity, treatment response, and functional outcomes. The long-term goal is to establish a comprehensive digital mental health platform that integrates biological, behavioral, and clinical dimensions, providing a scalable model for improving geriatric mental health in Taiwan's aging population.

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Alabama
      • London, Alabama, United Kingdom, WC1N 2AN
        • China Medical University Beigang Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), either single or recurrent episode.
  2. Have a Hamilton Depression Rating Scale (HAM-D, 17-item) total score of 14 or higher at baseline.
  3. Participants who are currently taking medications that may affect mood, sleep, or circadian rhythms (e.g., antidepressants, sedative antipsychotics, or sleep aids) may be included, provided that the dosage has remained stable for at least two weeks prior to enrollment.
  4. Prior to inclusion, informed consent must be obtained. If cognitive impairment prevents subjects from signing, consent may be obtained from their primary caregiver (who may be a legal or professional representative).

Exclusion Criteria:

  1. Diagnosis of dementia of any severity, bipolar disorder, psychotic disorder, psychotic episode, or substance use disorder.
  2. Active suicidal ideation or suicide attempt within the past three months.

  3. Any other conditions deemed unsuitable for participation by the clinical physician, such as:

    • Currently experiencing acute delirium.
    • Suffering from respiratory infections, including COVID-19.

  4. Participants with significant skin conditions on the head or conditions that could affect the efficacy of light therapy will be excluded. These include cases with:

    • Hemangiomas.
    • Scleroderma.
    • Psoriasis.
    • Rashes.
    • Open wounds.
    • Tattoos on the head. Additionally, individuals with head implants or those who have undergone photosensitizing drug treatments within two weeks prior to trial participation will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photobiomodulation
Participants allocated to this arm will receive photobiomodulation for up to 8 weeks, using a wearable headband.
Device: Photobiomodulation
A near-infrared photobiomodulation wearable device.
Sham Comparator: sham
Participants allocated to this arm will not receive photobiomodulation for up to 8 weeks, using a sham wearable headband.
Device: Sham (No Treatment)
Participants allocated to this arm will receive neglectable photobiomodulation for up to 8 weeks, using a sham wearable headband.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep and Circadian Rhythm
Time Frame: 8 weeks post-treatment.

Sleep and circadian rhythm will be assessed using both questionnaire-based and device-based approaches.

The questionnaire-based component will employ the Pittsburgh Sleep Quality Index (PSQI), which provides a total score ranging from 0 to 21, with lower scores indicating better sleep quality.

The device-based component will analyze data from Geneactiv, processed with the validated open-source GGIR algorithm.

  1. Five sleep variables will be derived: sleep onset time, wake-up time, total sleep duration, sleep efficiency, and wake after sleep onset (WASO).
  2. Seven circadian rhythm variables will also be analyzed: light exposure amount and timing, M5/L5 (five-hour periods of highest/lowest activity), mean sleep midpoint time (MSA), intra-daily variability (IV), inter-daily stability (IS), daytime napping, and the Sleep Regularity Index (SRI).
8 weeks post-treatment.
Depression
Time Frame: 8 weeks post-treatment.
Depression severity will be assessed using both questionnaire-based and device-based approaches. The questionnaire-based component will employ the depression severity assessed using the Hamilton Depression Rating Scale (HAM-D, 17-item version) which provides a total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The device-based behavioral correlates (e.g., daytime activity, sleep fragmentation, light exposure regularity) derived from Geneactiv actigraphy will be analyzed to explore relationships with depressive symptom changes. Qualitative interviews will supplement quantitative findings to explore patient-reported mood changes and subjective well-being during the trial.
8 weeks post-treatment.
Feasibility, Acceptability, and User Experience of Device-Based Measurement and Management
Time Frame: From enrollment to the end of trial at 12 weeks

Feasibility, satisfaction, and user experience with Geneactiv actigraphy and near-infrared photobiomodulation devices will be evaluated using:

Quantitative assessments - Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST, Taiwanese version), compliance rate (measured by device-wearing duration and adherence), and completion rate of scheduled assessments.

Qualitative interviews - conducted post-intervention to capture participants' experiences, perceived usability, and barriers to adoption.

Data will be analyzed thematically to identify key factors affecting acceptability and implementation.
From enrollment to the end of trial at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH114-REC2-068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will decide if the IPD can be shared before the end of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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