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NCT07232472
NA

Wearable-Based Study of Depression and Sleep in Older Adults

Sponsor: China Medical University Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2026-03-01

Completion Date

2029-12-31

Last Updated

2026-02-11

Healthy Volunteers

No

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.

Locations (1)

China Medical University Beigang Hospital

London, Alabama, United Kingdom