Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Training Therapy for Chronic Subjective Tinnitus

N/ANot Yet RecruitingNCT07469969

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University386 enrolled

Overview

This study is a prospective, multicenter, randomized, controlled, open-label clinical trial designed to evaluate the superiority of transauricular vagus nerve microcurrent stimulation (taVNS) combined with Tailor-Made Notched Music Training (TMNMT) compared with Tinnitus Retraining Therapy (TRT) in patients with chronic subjective tinnitus. A total of 386 participants aged 18-70 years with a tinnitus duration of at least 6 months and a Tinnitus Handicap Inventory (THI) score ≥38 will be enrolled, excluding individuals with severe hearing loss, organic cranial diseases, or other contraindications. Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. The control group will receive standardized TRT, including habituation sound therapy and structured educational counseling, while the experimental group will receive TMNMT combined with taVNS (0.1 Hz pulse-train stimulation, sub-pain threshold intensity of 0.5-10 mA). Although the trial is open-label, outcome assessors and statisticians will remain blinded to group allocation. Baseline and follow-up assessments include THI, visual analog scale (VAS), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), audiological evaluations, and multimodal neuroimaging using EEG and fMRI. The primary outcome is the tinnitus improvement response rate at 3 months after treatment initiation, defined as a reduction of more than 7 points in the THI score from baseline. Secondary outcomes include treatment response rates at 6 and 12 months, changes in tinnitus severity and tinnitus-related comorbid symptoms, and neuroplasticity-related changes in central neural mechanisms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

386

Interventions

transcutaneous auricular vagus nerve stimulation combined with tailor-made notched music training therapyDEVICE

This group receives combined transcutaneous auricular vagus nerve stimulation (taVNS) and tailor-made notched music training (TMNMT) delivered through a single, registered Class II medical device. The device synchronously administers taVNS (0.1 Hz, pulse train, 0.5-10 mA, titrated below individual pain threshold) and delivers TMNMT via integrated, phase-synchronized algorithms. The notched music is centered at the patient's tinnitus frequency with a ½-octave bandwidth. Treatment consists of 30-minute sessions, four times daily for 3 months.

tinnitus retraining therapyDEVICE

This group receives standard Tinnitus Retraining Therapy (TRT) using the same device platform, but without active microcurrent output. Therapy includes structured counseling and sound therapy, where broadband natural sounds are delivered at a individually set "mixing" level via the device. Daily sound exposure totals 2 hours over 3 months, supported by initial education and follow-up counseling sessions focused on habituation and cognitive restructuring.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients whose primary complaint is tinnitus and who seek medical care for this reason 2. Patients diagnosed with chronic tinnitus for more than 6 months 3. Age between 18 and 70 years 4. Tinnitus frequency within the range of 125-8000 Hz 5. Hearing threshold not exceeding 70 dB HL 6. Tinnitus Handicap Inventory (THI) score ≥ 38 points. Exclusion Criteria: 1. Patients with conductive hearing loss, history of middle ear surgery, pulsatile tinnitus due to vascular malformations, or tinnitus associated with Meniere's disease 2. History of head trauma, central nervous system disorders, psychiatric disorders, or substance abuse/dependence 3. Patients unwilling or unable to comply with the study protocol requirements 4. Patients with space-occupying lesions in the peripheral auditory pathway or central nervous system (e.g., acoustic neuroma, middle ear cholesteatoma, meningioma) as identified by imaging studies.

Outcomes

Primary Outcomes

Tinnitus Improvement Response Rate

The Tinnitus Improvement Response Rate is evaluated based on the change in Tinnitus Handicap Inventory (THI) scores. A higher score indicates greater interference of tinnitus with quality of life. Treatment response is defined as a reduction in the THI score of \>7 points from the baseline assessment after 3 months of treatment, based on the internationally recognized Minimal Clinically Important Difference (MCID) threshold. Calculation Formula: Tinnitus Improvement Response Rate (%) = (Number of Responders / Total Number of Cases in the Corresponding Group) × 100%

Time frame: Before treatment and at the end of the 3-month treatment period

Secondary Outcomes

Change in Self-Perceived Tinnitus Loudness assessed by Visual Analogue Scale (VAS) Score

Patients rate their current perception of tinnitus loudness on a Visual Analogue Scale (VAS) ranging from 0 to 10. A score of 0 represents "extremely faint/imperceptible" tinnitus, and 10 represents "extremely loud/intolerable" tinnitus. The outcome is reported as the change in score from Baseline.