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NCT07298876
Low-intensity Hippocampal Transcranial Ultrasound Stimulation for Managing Cognitive and Sleep Dysfunction in Preclinical Alzheimer's Disease
NA trial testing Low-intensity transcranial ultrasound stimulation in Sleep Disturbances in 20 participants. Enrolling by invitation.
31 March 2027
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 April 2026 |
| Primary completion | 31 March 2027 |
| Estimated completion | 16 May 2027 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Low-intensity transcranial ultrasound stimulation
- Sham low-intensity transcranial ultrasound stimulation
Conditions studied
- Sleep Disturbances — all drugs for Sleep Disturbances →
- Aging — all drugs for Aging →
- Cognitive Impairment, Mild — all drugs for Cognitive Impairment, Mild →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 60 to 85, any sex, with Sleep Disturbances or Aging. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07298876
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07298876 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 23 December 2025
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