{"type":"trials","record":{"id":28590,"source_id":"clinicaltrials-gov","external_id":"NCT07232472","title":"Wearable-Based Study of Depression and Sleep in Older Adults","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.","overall_status":"Enrolling By Invitation","phases":[],"study_type":"INTERVENTIONAL","sponsor":"China Medical University Hospital","enrollment":162,"countries":["United Kingdom"],"start_date":"2026-04-23","completion_date":"2029-12-31","last_update_date":"2026-06-17","source_url":"https://clinicaltrials.gov/study/NCT07232472","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Enrolling By Invitation. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:15.763923+00:00","last_seen_at":"2026-09-25T06:25:39.067+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years","comparator":null,"organization":"China Medical University Hospital","interventions":["Photobiomodulation","Sham (No Treatment)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Sleep and Circadian Rhythm — 8 weeks post-treatment.","Depression — 8 weeks post-treatment.","Feasibility, Acceptability, and User Experience of Device-Based Measurement and Management — From enrollment to the end…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Elderly Depression","Sleep Disturbance","Photobiomodulation","Sham (No Treatment)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: wearable.","quality_checked_at":"2026-09-25T06:25:42.287439+00:00","duplicate_cluster_key":"id:nct07232472","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-04-23 to 2029-12-31","comparator":null,"confidence":"structured-source","population":"ALL · 60 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:39.082Z","intervention":["Photobiomodulation","Sham (No Treatment)"],"participants":162,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Sleep and Circadian Rhythm — 8 weeks post-treatment.","Depression — 8 weeks post-treatment.","Feasibility, Acceptability, and User Experience of Device-Based Measurement and Management — From enrollment to the end…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"digital-biomarkers","is_published":true,"match_reasons":["Title contains controlled term: wearable.","Abstract contains controlled term: wearable.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Digital biomarkers","slug":"digital-biomarkers"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/28590","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}