Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Training Therapy for Chronic Subjective Tinnitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous auricular vagus nerve stimulation combined with tailor-made notched music training therapy, tinnitus retraining therapy.
- Who it may be relevant to
- Registry conditions: Chronic Subjective Tinnitus. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Training Therapy for Chronic Subjective Tinnitus: A Multicenter, Randomized, Controlled, Open-label Trial
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.
Interventions
- Device transcutaneous auricular vagus nerve stimulation combined with tailor-made notched music training therapy
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-m - Device tinnitus retraining therapy
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.
Primary outcome measures
- Tinnitus Improvement Response Rate [Time frame: Before treatment and at the end of the 3-month treatment period]
Secondary outcome measures (11)
- Change in Self-Perceived Tinnitus Loudness assessed by Visual Analogue Scale (VAS) Score [Time frame: Baseline, Month 3, Month 6, Month 12]
- Change in Tinnitus Loudness Matching Threshold [Time frame: Baseline, Month 3, Month 6, Month 12]
- Number of Participants with Treatment-Related Adverse Events [Time frame: From Baseline through Month 3]
- Change in Beck Anxiety Inventory (BAI) Standardized Score [Time frame: Baseline, Month 3, Month 6, Month 12]
- Change in Beck Depression Inventory (BDI) Total Score [Time frame: Baseline, Month 3, Month 6, Month 12]
- Change in Pittsburgh Sleep Quality Index (PSQI) Global Score [Time frame: Baseline, Month 3, Month 6, Month 12]
- Percentage of Participants Achieving Minimal Clinically Important Difference in THI Score [Time frame: Month 6, Month 12]
- Change in Quantitative EEG (qEEG) Spectral and Connectivity Metrics (0.5-100 Hz) [Time frame: Baseline, Month 3, Month 6]
- Change in Functional MRI (fMRI) BOLD Signal and Network Connectivity [Time frame: Baseline, Month 3, Month 6]
- Change in Structural MRI Morphometry (Gray Matter Volume and Cortical Thickness) [Time frame: Baseline, Month 3, Month 6]
- Change in Diffusion MRI Metrics and Glymphatic System Activity (DTI-ALPS) [Time frame: Baseline, Month 3, Month 6]
Eligibility criteria
Inclusion criteria
- Patients whose primary complaint is tinnitus and who seek medical care for this reason
- Patients diagnosed with chronic tinnitus for more than 6 months
- Age between 18 and 70 years
- Tinnitus frequency within the range of 125-8000 Hz
- Hearing threshold not exceeding 70 dB HL
- Tinnitus Handicap Inventory (THI) score ≥ 38 points.
Exclusion criteria
- Patients with conductive hearing loss, history of middle ear surgery, pulsatile tinnitus due to vascular malformations, or tinnitus associated with Meniere's disease
- History of head trauma, central nervous system disorders, psychiatric disorders, or substance abuse/dependence
- Patients unwilling or unable to comply with the study protocol requirements
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07469969 · SYS-5010-202601