An interventional study of taVNS Combined With TMNMT and Sham taVNS Combined With TMNMT in Chronic Subjective Tinnitus, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 6 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 444 is above the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
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Exclusion Criteria
Participants receive active 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.
Device: taVNS Combined With TMNMT
Participants receive sham transcutaneous auricular vagus nerve stimulation (taVNS) combined with the same Tailor-Made Notched Music therapy (TMNMT) as the experimental arm 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.
Device: Sham taVNS Combined With TMNMT
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.
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.
Effective Rate of Tinnitus Improvement at 3 Months
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%.
Time frame: Baseline and 3 months after treatment initiation
Effective Rate of Tinnitus Improvement at 6 and 12 Months
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%.
Time frame: Baseline, 6 months, and 12 months after treatment initiation
Change in Visual Analog Scale (VAS) Score for Tinnitus Loudness
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.
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Acoustic Tinnitus Match Loudness
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.
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Beck Anxiety Inventory (BAI) Score
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.
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Beck Depression Inventory (BDI) Score
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.
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Pittsburgh Sleep Quality Index (PSQI) Score
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.
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Resting-State EEG Features
Change in resting-state EEG features, including power spectrum entropy and oscillatory characteristics, from baseline to post-treatment and follow-up.
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Change in MRI Features
Change in MRI features from baseline to post-treatment and follow-up.
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Safety Outcomes: Incidence of Treatment-Related Adverse Events
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%.
Time frame: From treatment initiation through 3 months (end of treatment)
Change From Baseline in Gut Microbiome Shannon Diversity Index
Gut microbial alpha diversity will be assessed using the Shannon diversity index in stool samples collected at baseline, 3 months, and 6 months.
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Change From Baseline in Blood Metabolite Abundance
Blood metabolite abundance will be assessed at baseline, 3 months, and 6 months using metabolomic profiling.
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Change From Baseline in Blood Protein Abundance
Blood protein abundance will be assessed at baseline, 3 months, and 6 months using proteomic profiling.
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Plan to share: No
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