NCT06776705 Low-intensity TUS for Sleep Disturbances in Patients With Chronic Tinnitus
| NCT ID | NCT06776705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14 participants in total. It began in 2025-01-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Tinnitus, as a common symptom, can jeopardize the sleep quality and brain function and even lead to hearing loss and cognitive decline in elderly patients. The co-occurring tinnitus and sleep disturbances can significantly affect the cognitive functions and quality of life, and even be implicated as a key contributing factor in the development of prodromal dementia. At present, very few non-pharmacological therapies are developed for managing these comorbidities in elderly patients. Focused low-intensity transcranial ultrasound stimulation (TUS) enables to stimulation the deep brain structures, such as hippocampus, with optimized focality and specific frequency. Objectives: We aim to 1) investigate the safety, feasibility and efficacy of a 2-week focused low-intensity TUS on the severity of tinnitus and sleep disturbances in elderly patients; 2) determine the sample size of a full-scale randomized clinical trial of low-intensity TUS in patients with tinnitus; 3) evaluate the effects of low-intensity TUS on the severity of tinnitus, sleep quality and cognitive functions at 2, 4 and 6 weeks after the treatments. Design: A 2-week randomized, double-blind, controlled clinical trial. Methods: Chinese right-handed tinnitus 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 7 participants per arm. Before intervention, T1-weighted magnetic resonance imaging (MRI) and diffusion-weighted imaging (DWI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and quality of life will be conducted at baseline, 2nd week, 4th week and 6th week. Program adherence and adverse effects will be monitored throughout intervention.
Eligibility Criteria
Inclusion Criteria: * Chinese, right-handed, aged from 60 to 80 years. * Chronic tinnitus is defined as tinnitus with a duration of at least 3 months. Depending on the justification, different time course definitions of chronic tinnitus are possible. * Sleep disturbances are defined as a Pittsburgh Sleep Quality Index (PSQI) total score above 5. * No interference with independence in everyday activities. Exclusion Criteria: * Diseases of ear canal and tympanic membrane checked by otoscopic examination. * Previous diagnosis of Meniere's disease and acoustic neuromas. * Past history of neurological or mental disorders. * Physically frail affecting attendance to treatment sessions. * Already attending regular treatments, such as cognitive behavioral therapy or music therapy. * Taking a psychotropic or other medication known to affect hearing functions. * Significant communicative impairments.
Contact & Investigator
Hanna LU, PhD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06776705 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06776705 currently recruiting?
Yes, NCT06776705 is actively recruiting participants. Contact the research team at xini@cuhk.edu.hk for enrollment information.
Where is the NCT06776705 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT06776705 clinical trial?
NCT06776705 is sponsored by Chinese University of Hong Kong. The principal investigator is Hanna LU, PhD at Chinese University of Hong Kong. The trial plans to enroll 14 participants.