Chronic Subjective Tinnitus
Conditions
Brief summary
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.
Interventions
DEVICEtaVNS 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.
DEVICESham taVNS Combined With TMNMT
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.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with tinnitus as the primary chief complaint and the reason for seeking medical consultation. 2. Patients with chronic subjective tinnitus duration of 6 months or longer. 3. Age between 18 and 70 years. 4. Tinnitus frequency within the range of 125-8000 Hz. 5. Hearing threshold ≤ 70 dB HL. 6. Tinnitus Handicap Inventory (THI) score ≥ 38.
Exclusion criteria
1. Patients with conductive hearing loss, history of middle ear surgery, pulsatile tinnitus due to vascular malformations, or Meniere's disease-related tinnitus. 2. 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. 3. Patients unwilling or unable to comply with study protocol requirements. 4. Patients with peripheral auditory pathway or central space-occupying lesions identified by imaging, such as acoustic neuroma, middle ear cholesteatoma, or meningioma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Rate of Tinnitus Improvement at 3 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Effective Rate of Tinnitus Improvement at 6 and 12 Months | 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%. |
| Change in Visual Analog Scale (VAS) Score for Tinnitus Loudness | 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. |
| Change in Acoustic Tinnitus Match Loudness | 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. |
| Change in Beck Anxiety Inventory (BAI) Score | 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. |
| Change in Beck Depression Inventory (BDI) Score | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) Score | 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. |
| Change in Resting-State EEG Features | 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. |
| Change in MRI Features | Baseline, 3 months, and 6 months after treatment initiation | Change in MRI features from baseline to post-treatment and follow-up. |
| Safety Outcomes: Incidence of Treatment-Related Adverse Events | 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%. |
Countries
China
Contacts
CONTACTYuexin Cai, Doctor
CONTACTQianhui Xu, MD
STUDY_CHAIRYuexin Cai, Doctor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed