Wearable-Based Study of Depression and Sleep in Older Adults

NCT07232472 | Not Yet Recruiting

• 1 other identifier: CMUH114-REC2-068
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

wearable device; sleep disturbance; elderly depression; sleep; Photobiomodulation; Digital biomarkers

Outcome Measures

Primary Outcomes (3)

• Sleep and Circadian Rhythm

  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

  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

  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

Study Arms (2)

Photobiomodulation

EXPERIMENTAL

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

Device: Photobiomodulation

sham

SHAM COMPARATOR

Participants allocated to this arm will not receive photobiomodulation for up to 8 weeks, using a sham wearable headband.

Device: Sham (No Treatment)

Interventions

Photobiomodulation DEVICE

A near-infrared photobiomodulation wearable device.

Photobiomodulation

Sham (No Treatment) DEVICE

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

sham

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have a Hamilton Depression Rating Scale (HAM-D, 17-item) total score of 14 or higher at baseline.
• 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.

You may not qualify if:

• Diagnosis of dementia of any severity, bipolar disorder, psychotic disorder, psychotic episode, or substance use disorder.
• Active suicidal ideation or suicide attempt within the past three months.
• Any other conditions deemed unsuitable for participation by the clinical physician, such as:
• Currently experiencing acute delirium.
• Suffering from respiratory infections, including COVID-19.
• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Beigang Hospital

London, Alabama, WC1N 2AN, United Kingdom

Location

Related Publications (2)

• Guu TW, Muurling M, Khan Z, Kalafatis C, Aarsland D, Ffytche D, Brem AK. Wearable devices: underrepresentation in the ageing society. Lancet Digit Health. 2023 Jun;5(6):e336-e337. doi: 10.1016/S2589-7500(23)00069-9. No abstract available.

  PMID: 37236695 RESULT

• Guu TW, Cassano P, Li WJ, Tseng YH, Ho WY, Lin YT, Lin SY, Chang JP, Mischoulon D, Su KP. Wearable, self-administered transcranial photobiomodulation for major depressive disorder and sleep: A randomized, double blind, sham-controlled trial. J Affect Disord. 2025 Mar 1;372:635-642. doi: 10.1016/j.jad.2024.12.065. Epub 2024 Dec 18.

  PMID: 39706483 RESULT

MeSH Terms

Conditions

Parasomnias

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD

CONTACT

+886-57837901; 066753@tool.caaumed.org.tw

Li-Yun Wan, MS.

CONTACT

liyun901106@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Psychiatrist

Model Details: Randomised, sham-controlled trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

GB (1)