{"type":"trials","record":{"id":86579,"source_id":"isrctn","external_id":"ISRCTN93133646","title":"The effect of light and/or melatonin on sleep, mood, cognition and behavior in demented elderly","brief_summary":"A large proportion of the demented elderly show fragmented sleep-wake patterns and disturbed circadian rhythms. It appears that the amplitude of the circadian rhythms is attenuated with age, with an exaggerated decline in demented elderly. Decreased input of entraining stimuli, due to diminished stimulation by environmental light and by lower levels of the pineal hormone melatonin to the SupraChiasmatic Nucleus (SCN), the pacemaker of the circadian timing system, might contribute to these disturbances. So far hopeful results have been found for light and melatonin in relatively small groups of patients. We now want to test the effect in a large group of patients to be able to differentiate the effects according to different subject related co-variables and to test the combination of light and melatonin.","overall_status":"Completed","phases":[],"study_type":"Interventional","sponsor":"Netherlands Institute for Brain Research (The Netherlands)","enrollment":189,"countries":["Netherlands"],"start_date":"1999-06-01","completion_date":"2003-04-01","last_update_date":"2008-07-18","source_url":"https://www.isrctn.com/ISRCTN93133646","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T03:45:38.915204+00:00","last_seen_at":"2026-09-25T03:45:38.816+00:00","metadata":{"sex":"All","age_range":"Senior","comparator":null,"attribution":"Source: ISRCTN ISRCTN93133646; retrieved 2026-09-25","interventions":["Other"],"reuse_license":"Registry contribution CC BY 4.0; generated metadata CC0","registry_source":"ISRCTN","outcome_measures":["Before starting the supplementation of light and melatonin all subjects were tested for their rest-activity rhythm by a…","No secondary outcome measures"],"design_description":"Interventional","source_has_results":false},"controlled_terms":["Dementia, dementia symptoms","Ceiling mounted indirect bright light (1000 lux in gaze direction) or ceiling mounted placebo light (300 lux in gaze di…","Results","Other"],"relevance_confidence":100,"source_quality_score":98,"freshness_score":35,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T03:45:39.558477+00:00","duplicate_cluster_key":"id:isrctn93133646","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"1999-06-01 to 2003-04-01","comparator":null,"confidence":"structured-source","population":"All · Senior","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":"2026-09-25T03:45:38.874Z","intervention":["Other"],"participants":189,"study_design":"Interventional","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":["Before starting the supplementation of light and melatonin all subjects were tested for their rest-activity rhythm by a…","No secondary outcome measures"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"sleep","is_published":true,"match_reasons":["Title contains controlled term: sleep.","Abstract contains controlled term: sleep, circadian.","Title supplies longevity context: elderly.","Study type is explicitly identified as Interventional."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sleep","slug":"sleep"}}],"content_sources":{"name":"ISRCTN Registry","homepage_url":"https://www.isrctn.com/"}},"canonical_url":"https://www.immortal.life/trials/86579","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}