Wearable-Based Study of Depression and Sleep in Older Adults (NCT07232472) | Clinical Trial Compass
By InvitationNot Applicable
Wearable-Based Study of Depression and Sleep in Older Adults
United Kingdom162 participantsStarted 2026-04-23
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 range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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:
. 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: