Actively Recruiting
Led by Chinese University of Hong Kong · Updated on 2025-07-18
14
Participants Needed
2
Research Sites
25 weeks
Total Duration
Researchers are studying the effects of low-intensity transcranial ultrasound stimulation (TUS) on elderly patients aged 60 to 85 who have chronic tinnitus alongside sleep disturbances. This study aims to evaluate the safety, feasibility, and impact of TUS on the severity of tinnitus, sleep quality, and cognitive functions. The trial also seeks to gather data to plan a larger future study and improve understanding of the relationship between tinnitus, sleep, and cognition, particularly in age-related neurodegenerative conditions. Participants will be randomly assigned to one of two groups for a 2-week intervention: one group will receive active low-intensity TUS at 500 kHz, while the other will receive a sham (placebo) TUS treatment without actual stimulation. Before treatment, individual MRI scans will help create personalized head models for precise targeting. Assessments will be conducted at the start and follow-ups at 2, 4, and 6 weeks after treatment to track changes in tinnitus symptoms, sleep quality, cognitive performance, and quality of life. Throughout the study, participants will undergo comprehensive evaluations including sleep quality questionnaires, cognitive tests, and brain imaging. Researchers will monitor adherence to the treatment and any adverse effects. The main outcomes measured will be changes in tinnitus symptoms and sleep quality after 12 weeks, with cognitive function and quality of life as secondary outcomes. The total participation involves multiple visits over approximately six weeks, with close monitoring for safety and treatment effects.
CONDITIONS
Low-intensity TUS for Sleep Disturbances in Patients With Chronic Tinnitus
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either active low-intensity transcranial ultrasound stimulation or sham stimulation as part of the study intervention.
Multiple visits during the 12 weeks for treatment sessions
Duration - Up to 12 weeks after treatment
Participants are monitored for changes in tinnitus symptoms, sleep quality, cognitive functions, and quality of life after treatment.
Visits at follow-up assessment time points
Total: 2 locations
1
Tai Po Hospital
Hong Kong, Hong Kong, Hong Kong, 100000
Not Yet Recruiting
2
Tai Po Hospital
Hong Kong, Tai Po District, Hong Kong, 100000
Actively Recruiting
X
Xi Ni, PhD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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Xi Ni, Yuk Shan Yuen, Zeyan Li...
https://pubmed.ncbi.nlm.nih.gov/40768410