Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus

ClinicalTrials.gov ID

NCT07794462

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

444Estimated

Last Update Posted

Aug 31, 2026Actual

Start Date

Oct 1, 2026Estimated

Primary Completion Date

Oct 30, 2030Estimated

Completion Date

Dec 30, 2030Estimated

Official Title

Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus: A Multicenter, Randomized, Double-Blind Controlled Clinical Trial

Brief Summary

The goal of this multicenter, randomized, double-blind clinical trial is to compare two treatments for adults with chronic subjective tinnitus. Researchers will determine whether transcutaneous auricular vagus nerve stimulation (taVNS) plus Tailor-Made Notched Music therapy (TMNMT) provides greater relief than the same music therapy combined with sham taVNS.

A total of 444 participants aged 18 to 70 years will be enrolled at multiple study centers. Participants will be randomly assigned in a 1:1 ratio to receive taVNS plus TMNMT or sham taVNS plus the same TMNMT. The treatment period will last 3 months.

• Chronic Subjective Tinnitus

• taVNS Combined With TMNMT
• Sham taVNS Combined With TMNMT

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria

1. Patients with tinnitus as the primary chief complaint and the reason for seeking medical consultation.
2. Patients with chronic subjective tinnitus duration of 6 months or longer.
3. Age between 18 and 70 years.
4. Tinnitus frequency within the range of 125-8000 Hz.
5. Hearing threshold ≤ 70 dB HL.
6. Tinnitus Handicap Inventory (THI) score ≥ 38.

Exclusion Criteria

1. Patients with conductive hearing loss, history of middle ear surgery, pulsatile tinnitus due to vascular malformations, or Meniere's disease-related tinnitus.
2. History of head trauma, central nervous system disorders, or substance abuse/dependence. Patients with severe primary psychiatric disorders or acute episodes of severe psychological disturbances requiring priority specialist intervention. Patients with severe anxiety symptoms (Beck Anxiety Inventory [BAI] score ≥26), severe depressive symptoms (Beck Depression Inventory [BDI] score ≥29), or suicidal ideation identified during clinical interview will be excluded.
3. Patients unwilling or unable to comply with study protocol requirements.
4. Patients with peripheral auditory pathway or central space-occupying lesions identified by imaging, such as acoustic neuroma, middle ear cholesteatoma, or meningioma.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Jiaggfu1985@163.com+86 15820715830

jiongcongyuan@126.com+86 13480311910

cgping345@163.com86+15019918918

Shansun@fudan.edu.cn86+18917786102

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