{"type":"trials","record":{"id":30330,"source_id":"clinicaltrials-gov","external_id":"NCT05138848","title":"Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease","brief_summary":"Dementia caused by Alzheimer's disease affects approximately 5.6 million adults over age 65, with costs expected to rise from $307 billion to $1.5 trillion over the next 30 years. Behavioral interventions have shown promise for mitigating neurodegeneration and cognitive impairments. Sleep is a modifiable health behavior that is critical for cognition and deteriorates with advancing age and Alzheimer's disease. Thus, it is a priority to examine whether improving sleep modifies Alzheimer's disease pathophysiology and cognitive function. Extant research suggests that deeper, more consolidated sleep is positively associated with memory and executive functions and networks that underlie these processes. Preliminary studies confirm that time-in-bed restriction interventions increase sleep efficiency and non-rapid eye movement slow-wave activity (SWA) and suggest that increases in SWA are associated with improved cognitive function. SWA reflects synaptic downscaling predominantly among prefrontal connections. Downscaling of prefrontal connections with the hippocampus during sleep may help to preserve the long-range connections that support memory and cognitive function. In pre-clinical Alzheimer's disease, hyperactivation of the hippocampus is thought to be excitotoxic and is shown to leave neurons vulnerable to further amyloid deposition. Synaptic downscaling through SWA may mitigate the progression of Alzheimer's disease through these pathways. The proposed study will behaviorally increase sleep depth (SWA) through four weeks of time-in-bed restriction in older adults characterized on amyloid deposition and multiple factors associated with Alzheimer's disease risk. This study will examine whether behaviorally enhanced SWA reduces hippocampal hyperactivation, leading to improved task-related prefrontal-hippocampal connectivity, plasma amyloid levels, and cognitive function. This research addresses whether a simple, feasible, and scalable behavioral sleep intervention improves functional neuroimaging indices of excitotoxicity, Alzheimer's pathophysiology, and cognitive performance.","overall_status":"Completed","phases":["EARLY_PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"University of Pittsburgh","enrollment":99,"countries":["United States"],"start_date":"2022-01-03","completion_date":"2026-06-30","last_update_date":"2026-07-06","source_url":"https://clinicaltrials.gov/study/NCT05138848","editorial_summary":"A registered EARLY_PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:16.485702+00:00","last_seen_at":"2026-09-25T03:05:05.722+00:00","metadata":{"acronym":"ALPS","organization":"University of Pittsburgh","source_has_results":false},"controlled_terms":["Alzheimer Disease, Late Onset","Mild Cognitive Impairment","Sleep","Cognitive Change","Amyloid","Time in Bed Restriction","Sleep Schedule"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T03:05:13.494718+00:00","duplicate_cluster_key":"id:nct05138848","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-01-03 to 2026-06-30","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":"2026-09-25T03:42:03.02286+00:00","intervention":[],"participants":99,"study_design":"INTERVENTIONAL","subject_scope":"Human clinical study registration","evidence_stage":"EARLY_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":[],"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 adult.","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/30330","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}