Low-intensity transcranial ultrasound for sleep disturbances in people with chronic tinnitus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional feasibility study testing a 2-week course of focused low-intensity transcranial ultrasound stimulation (TUS) aimed at deep brain targets such as the hippocampus in older adults with chronic tinnitus and sleep disturbance. Primary outcomes are changes in tinnitus symptoms and sleep quality, with secondary outcomes including cognitive function and quality of life; analyses will use intention-to-treat and mixed-effects models. The protocol will also document tolerability, adherence, and adverse events to establish safety and to inform sample size for a future full-scale randomized trial. Participants are Chinese, right-handed adults aged 60–80 with chronic tinnitus (≥3 months) and a PSQI score >5, recruited at Tai Po Hospital in Hong Kong.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tai Po Hospital
  Hong Kong, Tai Po District, Hong Kong Recruiting
• Tai Po Hospital
  Hong Kong, Hong Kong, Hong Kong Not yet recruiting

Study contacts

• Principal investigator: Hanna LU, PhD — Chinese University of Hong Kong
• Study coordinator: Xi Ni, PhD
• Email: xini@cuhk.edu.hk
• Phone: 852-28314305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.