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NCT Number: NCT06776705

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

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 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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Key information

Conditions

Tinnitus Central Nervous System Diseases Cognition Cognition Disorders Cognitive Dysfunction Ear Diseases Hearing Disorders Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Parasomnias Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Sleep Disturbances Sleep Wake Disorders

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tai Po Hospital, Hong Kong

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About this study

Significance: This study aims to investigate the feasibility, safety and efficacy of low intensity TUS for sleep disturbances in patients with tinnitus. It wills also test the program adherence, tolerability and adverse effects of this innovative neurotechnology. Information will be helpful for in-depth understanding the relationship of "tinnitus, sleep and cognition" and guiding the further studies of otology, sleep medicine and age-related neurodegenerative diseases.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-intensity transcranial ultrasound stimulation

Device

Low-intensity TUS, as an advanced modality of transcranial brain stimulation, enables to stimulate the deep brain structures with optimized focality and specific frequency.

Primary outcomes

  1. Tinnitus Primary Functions Questionnaire (TPFQ)

    Time frame: 12 weeks

    A short 12-item version of TPFQ is used in this study. In the 12-item version, questions 7, 11, and 15 were chosen for concentration; questions 4, 8, and 10 were chosen for emotion; questions 2, 14, and 17 were chosen for hearing; and questions 16, 18, and 20 were chosen for sleep.

  2. Pittsburg Sleep Quality Index (PSQI)

    Time frame: 12 weeks

    The PSQI is a 19-item questionnaire that includes seven areas of subjective sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.77 to 0.83), sensitivity (89.6%), specificity (86.5%)(Buysse et al., 1988). Greater score of PSQI indicates worse sleep quality.

Secondary outcomes

  1. Tinnitus Handicap Inventory (THI)

    Time frame: 12 weeks

    THI is used to identify, quantify and evaluate the difficulties that patients with chronic tinnitus may experience in daily life. There are 25 items covering three aspects: functional, emotional and catastrophic. The THI score ranges from 0 to 100, with higher scores indicating more severe tinnitus burden and a seven-point change representing a minimal clinically important difference.

  2. Attention network test (ANT)

    Time frame: 12 weeks

    Complex attention is measured by ANT. Within ANT paradigm, there are four types of cues: no cue, center cue, double cue, and spatial cue; and three types of flankers: neutral, congruent, and incongruent. In a given trial, a central cross-fixation point presents 400 to 1,600 ms (randomized), subsequently is replaced for 100 ms by one of four warning cues. The target, a central arrow, could appear above or below the cross-fixation and is surrounded by two flankers on each side.

  3. Word-list learning test (WLLT)

    Time frame: 12 weeks

    WLLT, consisting of ten semantically non-associated words that is presented consecutively over three free trials of immediate recall, a 20-min delayed recall (to prevent recency effects).

Study contacts

Contact information is provided by the study sponsor or research team.

Xi Ni, PhD

CONTACT

[email protected]

852-28314305

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Pilot Randomized Controlled Trial of MRI-guided Focused Low-intensity Transcranial Ultrasound Stimulation (TUS) for Sleep Disturbances in Patients With Chronic Tinnitus

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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