Wearable-Based Study of Depression and Sleep in Older Adults (NCT07232472) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Wearable-Based Study of Depression and Sleep in Older Adults
United Kingdom162 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Prior to inclusion, informed consent must be obtained. If cognitive impairment prevents subjects from signing, consent may be obtained from their primary caregiver (who may be a legal or professional representative).
Exclusion criteria
✕. 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:
What they're measuring
1
Sleep and Circadian Rhythm
Timeframe: 8 weeks post-treatment.
2
Depression
Timeframe: 8 weeks post-treatment.
3
Feasibility, Acceptability, and User Experience of Device-Based Measurement and Management
Timeframe: From enrollment to the end of trial at 12 weeks
✕. 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: