{"type":"trials","record":{"id":31554,"source_id":"clinicaltrials-gov","external_id":"NCT05968820","title":"Sleep Health Enhancement in Older Adults to Address Frailty","brief_summary":"The objective of the proposed study is to tailor a sleep health enhancement intervention to older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot study will be conducted in two stages. In the treatment development stage, we will recruit n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report questionnaire) to assess acceptability and tailor the sleep health enhancement intervention for older adults. In the pilot study stage to assess preliminary efficacy of the tailored sleep health enhancement intervention, n=30 older adults with poor sleep health will be randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement intervention or to a wait-list control condition. Participants will wear wrist-worn actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and reassessments.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"University of Kansas Medical Center","enrollment":40,"countries":["United States"],"start_date":"2023-09-12","completion_date":"2024-08-30","last_update_date":"2024-09-19","source_url":"https://clinicaltrials.gov/study/NCT05968820","editorial_summary":"A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:25:39.067+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years","comparator":"Wait-List Control Group","organization":"University of Kansas Medical Center","interventions":["Sleep Health Enhancement Intervention"],"registry_source":"ClinicalTrials.gov","outcome_measures":["6-item Acceptability Scale — 6 week","semi-standardized qualitative interview — 6 week","Tilburg Frailty Indicator — baseline, 6 week and 12 week reassessments","WHOQOL-BREF — baseline, 6 week and 12 week reassessments","Ru_SATED sleep health composite — baseline, 6 week and 12 week reassessments","Pittsburgh Sleep Quality Index — baseline, 6 week and 12 week reassessments","Epworth Sleepiness Scale — baseline, 6 week and 12 week reassessments","Dysfunctional Beliefs About Sleep — baseline, 6 week and 12 week reassessments","Sleep Self-Efficacy — baseline, 6 week and 12 week reassessments","Actigraphy — baseline, 6 week and 12 week reassessments"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Frailty","Sleep Health Enhancement Intervention"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T06:25:42.287439+00:00","duplicate_cluster_key":"id:nct05968820","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-09-12 to 2024-08-30","comparator":"Wait-List Control Group","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":"2026-09-25T06:25:39.105Z","intervention":["Sleep Health Enhancement Intervention"],"participants":40,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1","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":["6-item Acceptability Scale — 6 week","semi-standardized qualitative interview — 6 week","Tilburg Frailty Indicator — baseline, 6 week and 12 week reassessments","WHOQOL-BREF — baseline, 6 week and 12 week reassessments","Ru_SATED sleep health composite — baseline, 6 week and 12 week reassessments","Pittsburgh Sleep Quality Index — baseline, 6 week and 12 week reassessments","Epworth Sleepiness Scale — baseline, 6 week and 12 week reassessments","Dysfunctional Beliefs About Sleep — baseline, 6 week and 12 week reassessments","Sleep Self-Efficacy — baseline, 6 week and 12 week reassessments","Actigraphy — baseline, 6 week and 12 week reassessments"],"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: frailty, frail.","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/31554","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}