Low-intensity transcranial ultrasound for sleep disturbances in people with chronic tinnitus
A Pilot Randomized Controlled Trial of MRI-guided Focused Low-intensity Transcranial Ultrasound Stimulation (TUS) for Sleep Disturbances in Patients With Chronic Tinnitus
This will test whether two weeks of focused low-intensity transcranial ultrasound to deep brain areas can reduce tinnitus severity and improve sleep in people aged 60–80 with chronic tinnitus and poor sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 2 sites (Hong Kong, Hong Kong and 1 other locations) |
| Trial ID | NCT06776705 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Chinese, right-handed adults aged 60–80 who have had chronic tinnitus for at least three months and a PSQI score above 5, and who can attend in-person sessions at the study site.
Not a fit: Patients with active ear canal or tympanic membrane disease, Meniere's disease, acoustic neuroma, prior neurological or major psychiatric disorders, significant communicative impairments, or those already receiving regular tinnitus therapies are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could provide a non-drug option to reduce tinnitus burden and improve sleep and related cognitive outcomes in older adults.
How similar studies have performed: Focused low-intensity transcranial ultrasound is an emerging technique with some early preclinical and small human safety signals, but there is limited published evidence specifically supporting benefit for tinnitus-related sleep problems.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong, Hong Kong and 1 other locations
- Tai Po Hospital — Hong Kong, Hong Kong, Hong Kong (Not_yet_recruiting)
- Tai Po Hospital — Hong Kong, Tai Po District, Hong Kong (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.