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Low-intensity TUS for Sleep Disturbances in Patients With Chronic Tinnitus

RecruitingNAAges 60 Years - 85 YearsAllChinese University of Hong Kong
NCT06776705 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Low-intensity transcranial ultrasound stimulation
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Where

2 sites
Tai Po Hospital
Hong Kong, Hong Kong
Tai Po Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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