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

NCT06776705 | Recruiting DMC

• 1 other identifier: 2023.636
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tinnitus; Sleep Disturbances; Cognition

Keywords

Tinnitus; Cognitive Dysfunction; Sleep distubances; Transcranial ultrasound stimulation; Hippocampus; Complex attention; Simulation; Central Nervous System Diseases

Outcome Measures

Primary Outcomes (2)

• Tinnitus Primary Functions Questionnaire (TPFQ)

  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.

  12 weeks

• Pittsburg Sleep Quality Index (PSQI)

  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.

  12 weeks

Secondary Outcomes (3)

• Tinnitus Handicap Inventory (THI)

  12 weeks

• Attention network test (ANT)

  12 weeks

• Word-list learning test (WLLT)

  12 weeks

Study Arms (2)

Active TUS

ACTIVE COMPARATOR

In active TUS group, participants will receive 500 kHz low-intensity TUS.

Device: Low-intensity transcranial ultrasound stimulation

Sham TUS

SHAM COMPARATOR

In sham TUS group, participants will not receive low-intensity TUS.

Device: Low-intensity transcranial ultrasound stimulation

Interventions

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.

Active TUS; Sham TUS

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Tai Po Hospital

Hong Kong, Hong Kong, 100000, Hong Kong

NOT YET RECRUITING

Tai Po Hospital

Hong Kong, Tai Po District, 100000, Hong Kong

RECRUITING

Related Publications (1)

• Ni X, Yuen YS, Li Z, Wang K, Yang NS, Yuan Y, Meng L, Guo L, Lu H. Focused low-intensity hippocampal transcranial ultrasound stimulation (TUS) for sleep disturbances in patients with chronic tinnitus: A study protocol for a pilot randomized controlled trial. PLoS One. 2025 Aug 6;20(8):e0329950. doi: 10.1371/journal.pone.0329950. eCollection 2025.

  PMID: 40768410 DERIVED

MeSH Terms

Conditions

Tinnitus; Parasomnias; Cognitive Dysfunction; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Hanna LU, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Ni, PhD

CONTACT

852-28314305; xini@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)