Wearable-Based Study of Depression and Sleep in Older Adults

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.

NCT Number	NCT07232472
Lead Sponsor	China Medical University Hospital
Conditions	Elderly Depression, Sleep Disturbance
Enrollment	162 participants
Start Date	2026-04-23
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-17