{"type":"trials","record":{"id":31427,"source_id":"clinicaltrials-gov","external_id":"NCT06944600","title":"Impact of Sleep Disorders and Digital Support on Older People's Health","brief_summary":"The goal of this observational study is to learn about the effects of sleep disorders on health and ageing in older people over the age of 65. The main question it aims to answer is: How do sleep disorders impact the motoric and cognitive ageing trajectories of older individuals? Participants will undergo a set of instrumental, laboratory and clinical diagnostic examinations to comprehensively assess the impact of sleep disorders on health.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"University of Parma","enrollment":300,"countries":[],"start_date":"2025-05-01","completion_date":"2027-11-01","last_update_date":"2025-04-25","source_url":"https://clinicaltrials.gov/study/NCT06944600","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:25:30.723+00:00","metadata":{"sex":"ALL","acronym":"SOMNUS-DARE","age_range":"65 Years","comparator":null,"organization":"University of Parma","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Incidence of physical and functional worsening — 12 months","Prevalence and incidence of sarcopenia — 24 months","Prevalence of mild cognitive impairment (MCI) and cognitive frailty — 24 months","Incidence of mild cognitive impairment (MCI) and cognitive frailty — 24 months","Incidence of dementia in cognitive frail older individuals — 24 months","Prevalence and incidence of recognised pre-frailty conditions — 24 months","Prevalence and incidence of malnutrition, polypharmacy and multimorbidity — 24 months"],"design_description":null,"source_has_results":false},"controlled_terms":["Sleep Disorders","Frailty","Cognitive Impairment","Quality of Life","Ageing","Digital Health","Multidisciplinary Approach"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T06:25:35.871646+00:00","duplicate_cluster_key":"id:nct06944600","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-05-01 to 2027-11-01","comparator":null,"confidence":"structured-source","population":"ALL · 65 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":"2026-09-25T06:25:30.741Z","intervention":[],"participants":300,"study_design":"OBSERVATIONAL","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":["Incidence of physical and functional worsening — 12 months","Prevalence and incidence of sarcopenia — 24 months","Prevalence of mild cognitive impairment (MCI) and cognitive frailty — 24 months","Incidence of mild cognitive impairment (MCI) and cognitive frailty — 24 months","Incidence of dementia in cognitive frail older individuals — 24 months","Prevalence and incidence of recognised pre-frailty conditions — 24 months","Prevalence and incidence of malnutrition, polypharmacy and multimorbidity — 24 months"],"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.","Source terminology contains: sleep.","Title supplies longevity context: older people.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sleep","slug":"sleep"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/31427","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}