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NCT Number: NCT07794462

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

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.

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Key information

Conditions

Chronic Subjective Tinnitus

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with conductive hearing loss, history of middle ear surgery, pulsatile tinnitus due to vascular malformations, or Meniere's disease-related tinnitus.
  • 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.
  • Patients unwilling or unable to comply with study protocol requirements.
  • Patients with peripheral auditory pathway or central space-occupying lesions identified by imaging, such as acoustic neuroma, middle ear cholesteatoma, or meningioma.

Treatment and study plan

taVNS Combined With TMNMT

Device

Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) combined with Tailor-Made Notched Music Therapy (TMNMT) for 3 months. taVNS is administered at 0.1 Hz, with a pulse width of 250-1000 ms and an intensity of 0-0.5 mA.

Sham taVNS Combined With TMNMT

Device

Participants receive sham transcutaneous auricular vagus nerve stimulation (sham taVNS) combined with Tailor-Made Notched Music Therapy (TMNMT) for 3 months. The initial sham stimulation parameters are 0.1 Hz, a pulse width of 250-1000 ms, and an intensity of 0-0.5 mA.

Primary outcomes

  1. Effective Rate of Tinnitus Improvement at 3 Months

    Time frame: Baseline and 3 months after treatment initiation

    Treatment response was defined as a reduction of ≥7 points in the THI score from baseline after 3 months of treatment (based on the internationally recognized minimal clinically important difference threshold). Effective rate (%) = (Number of responders / Total number of patients in the corresponding group) x 100%.

Secondary outcomes

  1. Effective Rate of Tinnitus Improvement at 6 and 12 Months

    Time frame: Baseline, 6 months, and 12 months after treatment initiation

    Treatment response was defined as a reduction of ≥7 points in the THI score from baseline after 6 and 12 months of treatment (based on the internationally recognized minimal clinically important difference threshold). Effective rate (%) = (Number of responders / Total number of patients in the corresponding group) x 100%.

  2. Change in Visual Analog Scale (VAS) Score for Tinnitus Loudness

    Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation

    Change in tinnitus loudness assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 (barely perceptible) to 10 (unbearably loud). The change score (ΔVAS) is calculated as the difference between post-treatment/follow-up scores and baseline. Higher scores indicate greater perceived loudness; a decrease in VAS score indicates improvement in loudness perception.

  3. Change in Acoustic Tinnitus Match Loudness

    Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation

    Change in acoustic tinnitus match loudness assessed using a calibrated audiometer in a standard sound-proof environment. The change in loudness threshold is calculated relative to baseline. Assessment method: audiologist-assessed.

  4. Change in Beck Anxiety Inventory (BAI) Score

    Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation

    Change in anxiety symptoms assessed using the Beck Anxiety Inventory (BAI), a 21-item self-reported questionnaire measuring the severity of anxiety symptoms over the past week. Higher scores indicate greater anxiety severity. The change score (ΔBAI) is calculated as the difference between post-treatment/follow-up scores and baseline. Assessment method: self-reported.

  5. Change in Beck Depression Inventory (BDI) Score

    Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation

    Change in depressive symptoms assessed using the Beck Depression Inventory (BDI). The change score (ΔBDI) is calculated as the difference between post-treatment/follow-up scores and baseline.

  6. Change in Pittsburgh Sleep Quality Index (PSQI) Score

    Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation

    Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The change score (ΔPSQI) is calculated as the difference between post-treatment/follow-up scores and baseline. Assessment method: self-reported.

  7. Change in Resting-State EEG Features

    Time frame: Baseline, 3 months, and 6 months after treatment initiation

    Change in resting-state EEG features, including power spectrum entropy and oscillatory characteristics, from baseline to post-treatment and follow-up.

  8. Change in MRI Features

    Time frame: Baseline, 3 months, and 6 months after treatment initiation

    Change in MRI features from baseline to post-treatment and follow-up.

  9. Safety Outcomes: Incidence of Treatment-Related Adverse Events

    Time frame: From treatment initiation through 3 months (end of treatment)

    Incidence of treatment-related adverse events, including auditory system-related events (e.g., ear canal or auricle burns, otalgia, hearing loss, tinnitus worsening) and non-auditory system-related events (e.g., dizziness, headache, palpitations, vomiting) occurring during the treatment period. Adverse event rate (%) = (Number of patients experiencing treatment-related adverse events / Total number of patients receiving treatment) × 100%.

Other outcomes

  1. Change From Baseline in Gut Microbiome Shannon Diversity Index

    Time frame: Baseline, 3 months, and 6 months after treatment initiation

    Gut microbial alpha diversity will be assessed using the Shannon diversity index in stool samples collected at baseline, 3 months, and 6 months.

  2. Change From Baseline in Blood Metabolite Abundance

    Time frame: Baseline, 3 months, and 6 months after treatment initiation

    Blood metabolite abundance will be assessed at baseline, 3 months, and 6 months using metabolomic profiling.

  3. Change From Baseline in Blood Protein Abundance

    Time frame: Baseline, 3 months, and 6 months after treatment initiation

    Blood protein abundance will be assessed at baseline, 3 months, and 6 months using proteomic profiling.

Study contacts

Contact information is provided by the study sponsor or research team.

Qianhui Xu, MD

CONTACT

[email protected]

86+13719908396

Yuexin Cai, Doctor

CONTACT

[email protected]

86+13825063663

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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