Low-intensity TUS for Sleep Disturbances in Patients With Chronic Tinnitus
NCT ID: NCT06776705
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
14 participants
INTERVENTIONAL
2025-01-15
2026-06-30
Brief Summary
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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.
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Detailed Description
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Data analysis: The primary outcomes will be the changes in tinnitus symptoms and sleep quality, and the comparisons of group differences across different time points. Secondary outcomes will be the changes of cognitive functions and quality of life. Intention-to-treat analysis will be carried out. Changes of efficacy indicators from baseline to each follow up point will be tested with mixed effect model.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Active TUS
In active TUS group, participants will receive 500 kHz low-intensity TUS.
Low-intensity transcranial ultrasound stimulation
Low-intensity TUS, as an advanced modality of transcranial brain stimulation, enables to stimulate the deep brain structures with optimized focality and specific frequency.
Sham TUS
In sham TUS group, participants will not receive low-intensity TUS.
Low-intensity transcranial ultrasound stimulation
Low-intensity TUS, as an advanced modality of transcranial brain stimulation, enables to stimulate the deep brain structures with optimized focality and specific frequency.
Interventions
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Low-intensity transcranial ultrasound stimulation
Low-intensity TUS, as an advanced modality of transcranial brain stimulation, enables to stimulate the deep brain structures with optimized focality and specific frequency.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
85 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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LU Hanna
Assistant Professor
Principal Investigators
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Hanna LU, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Tai Po Hospital
Hong Kong, Hong Kong, Hong Kong
Tai Po Hospital
Hong Kong, Tai Po District, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Hanna, PhD
Role: backup
References
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Ni X, Yuen YS, Li Z, Wang K, Yang NS, Yuan Y, Meng L, Guo L, Lu H. Focused low-intensity hippocampal transcranial ultrasound stimulation (TUS) for sleep disturbances in patients with chronic tinnitus: A study protocol for a pilot randomized controlled trial. PLoS One. 2025 Aug 6;20(8):e0329950. doi: 10.1371/journal.pone.0329950. eCollection 2025.
Other Identifiers
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2023.636
Identifier Type: -
Identifier Source: org_study_id
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