NCT07232472

Wearable-Based Study of Depression and Sleep in Older Adults

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Elderly Depression
• Sleep Disturbance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-11-18
• Last updated: 2026-02-11

Locations

1 site across 1 country: United Kingdom