{"type":"trials","record":{"id":85941,"source_id":"clinicaltrials-gov","external_id":"NCT03594851","title":"Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home","brief_summary":"Sleep disorder is often a complaint from the older people. Prevalence of sleep disorder increases with aging and reaches between 20 to 45% of the people of 65 years old and more. Sleep physiologically changes with aging. Sleep can also be disturbed by other factors such as intercurrent or related chronic pathologies, environmental change (institutionalized, death of a spouse…), or some medical treatments. Regardless of interindividual variabilities, normative criteria have been defined by a meta-analysis: insomnia can be diagnosed if night wakings are more than 60min and/or if sleep latency is more than 30 minutes. Various studies have proved the major role of sleep on health and wellbeing. Sleep disorders have an impact on the quality of perception of health and on the quality of life of people and their spouse. According to the French High Health Authority recommendations, sleep diary and validated scales are the tools to use to investigate sleep disorders. Results from previous studies brought us to consider sleep complaint more specifically and adjust to the heterogeneous population of the investigator's hospital with a subjective approach. This work intends to offer a program of individualized advice to older patients with no cognitive impairment, or with a mild or moderate cognitive impairment, who complain about their sleep quality. Patients with a moderate cognitive impairment who have a caregiver at home can also join the study. The main objective of the study is to evaluate the impact of individualized care for sleep disorders on quality of sleep using the Pittsburgh Sleep Quality Index which validity was demonstrated among the elderly.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Groupe Hospitalier de la Region de Mulhouse et Sud Alsace","enrollment":45,"countries":["France"],"start_date":"2018-01-08","completion_date":"2019-07-30","last_update_date":"2019-08-21","source_url":"https://clinicaltrials.gov/study/NCT03594851","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":"2026-09-25T03:26:02.039364+00:00","last_seen_at":"2026-09-25T03:26:01.923+00:00","metadata":{"acronym":"CISPAD","organization":"Groupe Hospitalier de la Region de Mulhouse et Sud Alsace","source_has_results":false},"controlled_terms":["Sleep Disorder","Complaint, Subjective Health","Pittsburgh Sleep Quality Index","Sleep diary","Katz Index of Independence in Activities of Daily Living","Lawton Instrumental Activities of Daily Living","Neuropsychiatric Inventory (Cummings)","Mini Zarit Caregiver Burden Scale, for the caregiver","Mini Mental state examination","Cornell Scale for Depression in Dementia","Quality of Life in Alzheimer's Disease"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T03:26:03.36019+00:00","duplicate_cluster_key":"id:nct03594851","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-01-08 to 2019-07-30","comparator":null,"confidence":"structured-source","population":null,"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":"2026-09-25T03:37:03.514931+00:00","intervention":[],"participants":45,"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":[],"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: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"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/85941","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}