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Wearable-Based Study of Depression and Sleep in Older Adults

NCT07232472 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-02-11

No results posted yet for this study

Summary

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.

Conditions

  • Elderly Depression
  • Sleep Disturbance

Interventions

DEVICE

Photobiomodulation

A near-infrared photobiomodulation wearable device.

DEVICE

Sham (No Treatment)

Participants allocated to this arm will receive neglectable photobiomodulation for up to 8 weeks, using a sham wearable headband.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07232472 on ClinicalTrials.gov