{"type":"trials","record":{"id":28113,"source_id":"clinicaltrials-gov","external_id":"NCT07298876","title":"Low-intensity Hippocampal Transcranial Ultrasound Stimulation for Managing Cognitive and Sleep Dysfunction in Preclinical Alzheimer's Disease","brief_summary":"Background: Sleep disturbances, as a common symptom, can jeopardize the brain health and cognitive function and even lead to cognitive impairments in older adults. The co-occurring sleep disturbances cognitive complaints can significantly affect brain functions, and even be implicated as a key contributing factor in the development of prodromal Alzheimer's disease (AD). At present, very few non-pharmacological therapies are developed for managing these comorbidities in older adults. Focused low-intensity transcranial ultrasound stimulation (TUS) enables to stimulation the deep brain structures, such as hippocampus, with optimized focality and specific frequency. Objectives: 1) To investigate the safety, feasibility and efficacy of a 2-week focused low-intensity hippocampal TUS on the severity of sleep disturbances and cognitive impairments in elderly patients; 2) to determine the sample size of a full-scale randomized clinical trial of low-intensity TUS in patients with preclinical AD; 3) to evaluate the effects of low-intensity TUS on the severity of sleep quality and cognitive functions at 2, 6 and 10 weeks after the treatments. Design: A 2-week randomized, double-blind, controlled clinical trial. Methods: Chinese right-handed preclinical AD patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 2-week intervention of either low intensity TUS or sham TUS, with 10 participants per arm. Before intervention, T1-weighted magnetic resonance imaging (MRI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and plasma p-tau217, Aß42 and Aß40 will be conducted at baseline, 2nd week, 6th week and 10th week. Program adherence and adverse effects will be monitored throughout intervention.","overall_status":"Enrolling By Invitation","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Chinese University of Hong Kong","enrollment":20,"countries":["Hong Kong"],"start_date":"2026-04-01","completion_date":"2027-05-16","last_update_date":"2025-12-23","source_url":"https://clinicaltrials.gov/study/NCT07298876","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Enrolling By Invitation. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:10.582012+00:00","last_seen_at":"2026-09-25T06:20:12.176+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 85 Years","comparator":"Active TUS","organization":"Chinese University of Hong Kong","interventions":["Low-intensity transcranial ultrasound stimulation","Sham low-intensity transcranial ultrasound stimulation"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Pittsburg Sleep Quality Index (PSQI) — 10 weeks","Delayed recall of the words — 10 weeks","Objective sleep quality — 2 weeks","The levels of plasma Aß — 10 weeks","The levels of plasma tau — 10 weeks"],"design_description":"RANDOMIZED · FACTORIAL · TREATMENT · TRIPLE","source_has_results":false},"controlled_terms":["Sleep Disturbances","Aging","Cognitive Impairment, Mild","Low-intensity transcranial ultrasound stimulation","Sham low-intensity transcranial ultrasound stimulation"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T06:20:12.449741+00:00","duplicate_cluster_key":"id:nct07298876","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-04-01 to 2027-05-16","comparator":"Active TUS","confidence":"structured-source","population":"ALL · 60 Years to 85 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":"2026-09-25T06:20:12.180Z","intervention":["Low-intensity transcranial ultrasound stimulation","Sham low-intensity transcranial ultrasound stimulation"],"participants":20,"study_design":"RANDOMIZED · FACTORIAL · TREATMENT · TRIPLE","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":["Pittsburg Sleep Quality Index (PSQI) — 10 weeks","Delayed recall of the words — 10 weeks","Objective sleep quality — 2 weeks","The levels of plasma Aß — 10 weeks","The levels of plasma tau — 10 weeks"],"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: aging.","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/28113","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}