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

March 9, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Training Therapy for Chronic Subjective Tinnitus: A Multicenter, Randomized, Controlled, Open-label Trial

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
386

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: taVNS + TMNMT
transcutaneous auricular vagus nerve stimulation combined with tailor-made notched music training therapy
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-minute sessions, four times daily for 3 months.
Active Comparator: TRT
Tinnitus Retraining Therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tinnitus Improvement Response Rate
Time Frame: Before treatment and at the end of the 3-month treatment period
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%
Before treatment and at the end of the 3-month treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Self-Perceived Tinnitus Loudness assessed by Visual Analogue Scale (VAS) Score
Time Frame: Baseline, Month 3, Month 6, Month 12
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.
Baseline, Month 3, Month 6, Month 12
Change in Tinnitus Loudness Matching Threshold
Time Frame: Baseline, Month 3, Month 6, Month 12
Based on the pitch characteristics described by the patient, a test stimulus (pure tone or narrow-band noise, 0.125-8.0 kHz) is selected. Using a bracketing procedure with 2 dB steps, the loudness is matched to the patient's tinnitus perception. The outcome is measured in decibels sensation level (dB SL/HL) relative to the patient's hearing threshold.
Baseline, Month 3, Month 6, Month 12
Number of Participants with Treatment-Related Adverse Events
Time Frame: From Baseline through Month 3
Total number of participants who experience treatment-related adverse events. Events include auditory system-related reactions (e.g., burns, earache, hearing deterioration, worsening tinnitus) and non-auditory reactions (e.g., dizziness, headache, palpitations, vomiting) deemed related to the intervention.
From Baseline through Month 3
Change in Beck Anxiety Inventory (BAI) Standardized Score
Time Frame: Baseline, Month 3, Month 6, Month 12
The BAI requires patients to rate 21 anxiety symptoms. The raw score is converted to a standardized score using the formula Y = int(1.19x). Scores range from 0 to 63, with higher scores indicating more severe anxiety. The outcome is reported as the change in standardized score from Baseline.
Baseline, Month 3, Month 6, Month 12
Change in Beck Depression Inventory (BDI) Total Score
Time Frame: Baseline, Month 3, Month 6, Month 12
The BDI consists of 21 groups of items. Scores are summed to obtain a total score ranging from 0 to 63. Higher scores indicate a more severe degree of depression. The outcome is reported as the change in total score from Baseline.
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
The PSQI assesses sleep quality. The Global Score ranges from 0 to 21, where a higher score indicates poorer sleep quality. The outcome is reported as the change in Global Score from Baseline.
Baseline, Month 3, Month 6, Month 12
Percentage of Participants Achieving Minimal Clinically Important Difference in THI Score
Time Frame: Month 6, Month 12
Evaluated based on the Tinnitus Handicap Inventory (THI). A "Responder" is defined as a participant showing a reduction in THI score of >7 points from baseline (the Minimal Clinically Important Difference). Reported as the percentage of participants in each group who meet this criterion.
Month 6, Month 12
Change in Quantitative EEG (qEEG) Spectral and Connectivity Metrics (0.5-100 Hz)
Time Frame: Baseline, Month 3, Month 6
Resting-state EEG data will be recorded and analyzed across the broad frequency spectrum (0.5-100 Hz). The outcome measures include: 1) Power Spectral Density (PSD) across global and local regions; 2) Functional connectivity metrics (e.g., Coherence, Phase Lag Index); and 3) Neural network synchronization. Analysis will be performed to assess changes in cortical activity and inhibition/excitation balance.
Baseline, Month 3, Month 6
Change in Functional MRI (fMRI) BOLD Signal and Network Connectivity
Time Frame: Baseline, Month 3, Month 6
Assessed using resting-state fMRI. Metrics include: 1) Amplitude of Low-Frequency Fluctuations (ALFF) and Regional Homogeneity (ReHo) to reflect local spontaneous brain activity; and 2) Functional Connectivity (FC) strength (z-transformed correlation coefficients) within auditory and non-auditory networks (e.g., Limbic system, Salience network, Default Mode Network).
Baseline, Month 3, Month 6
Change in Structural MRI Morphometry (Gray Matter Volume and Cortical Thickness)
Time Frame: Baseline, Month 3, Month 6
Structural MRI data (T1-weighted images) will be analyzed using Voxel-Based Morphometry (VBM) and surface-based methods. Key metrics include changes in regional Gray Matter Volume (GMV) and Cortical Thickness in tinnitus-related regions (e.g., auditory cortex, prefrontal cortex, hippocampus).
Baseline, Month 3, Month 6
Change in Diffusion MRI Metrics and Glymphatic System Activity (DTI-ALPS)
Time Frame: Baseline, Month 3, Month 6
Diffusion Tensor Imaging (DTI) will be used to assess white matter integrity and glymphatic function. Metrics include: 1) Fractional Anisotropy (FA) and Mean Diffusivity (MD) of auditory pathways; and 2) The DTI-ALPS (Analysis along the Perivascular Space) index, used as a proxy for measuring glymphatic system activity and waste clearance efficiency.
Baseline, Month 3, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yuexin Cai, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYS-5010-202601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be shared due to privacy concerns and ethical restrictions related to patient confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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