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

2026年8月28日更新者：Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

研究概览

地位

尚未招聘

条件

慢性主观性耳鸣

干预/治疗

研究类型

介入性

注册 (估计的)

444

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Yuexin Cai, Doctor
电话号码：86+13825063663
邮箱：caiyx25@mail.sysu.edu.cn

研究联系人备份

姓名：Qianhui Xu, MD
电话号码：86+13719908396
邮箱：xuqh9@mail2.sysu.edu.cn

学习地点

中国
- - Shanghai、中国
    - Eye & ENT Hospital, Fudan University
    - 接触：
      
      Shan Sun
      
      电话号码：86+18917786102
      
      邮箱：Shansun@fudan.edu.cn
- Guangdong
  - Guangzhou、Guangdong、中国、510120
    - Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    - 接触：
      
      Qianhui Xu, MD
      
      电话号码：13719908396
      
      邮箱：xuqh9@mail2.sysu.edu.cn
  - Huizhou、Guangdong、中国
    - Huizhou First People's Hospital
    - 接触：
      
      Jia Fu
      
      电话号码：+86 15820715830
      
      邮箱：Jiaggfu1985@163.com
  - Jieyang、Guangdong、中国
    - Jieyang People's Hospital
    - 接触：
      
      Jiongcong Yuan
      
      电话号码：+86 13480311910
      
      邮箱：jiongcongyuan@126.com
  - Zhongshan、Guangdong、中国
    - Zhongshan City People's Hospital
    - 接触：
      
      Guoping Chen
      
      电话号码：86+15019918918
      
      邮箱：cgping345@163.com
  - Zhuhai、Guangdong、中国、519000
    - Zhuhai Integrated Traditional Chinese and Western Medicine Hospital
    - 接触：
      
      Binbin Xiong
      
      电话号码：86+13926935096
      
      邮箱：xiongbb2015@126.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：四人间

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：taVNS + TMNMT Group 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.	设备：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.
假比较器：Sham taVNS + TMNMT Group 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.	设备：Sham 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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Effective Rate of Tinnitus Improvement at 3 Months 大体时间：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%.	Baseline and 3 months after treatment initiation

次要结果测量

结果测量	措施说明	大体时间
Effective Rate of Tinnitus Improvement at 6 and 12 Months 大体时间：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%.	Baseline, 6 months, and 12 months after treatment initiation
Change in Visual Analog Scale (VAS) Score for Tinnitus Loudness 大体时间：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.	Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Acoustic Tinnitus Match Loudness 大体时间：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.	Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Beck Anxiety Inventory (BAI) Score 大体时间：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.	Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Beck Depression Inventory (BDI) Score 大体时间：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.	Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Pittsburgh Sleep Quality Index (PSQI) Score 大体时间：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.	Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Resting-State EEG Features 大体时间：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.	Baseline, 3 months, and 6 months after treatment initiation
Change in MRI Features 大体时间：Baseline, 3 months, and 6 months after treatment initiation	Change in MRI features from baseline to post-treatment and follow-up.	Baseline, 3 months, and 6 months after treatment initiation
Safety Outcomes: Incidence of Treatment-Related Adverse Events 大体时间：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%.	From treatment initiation through 3 months (end of treatment)

其他结果措施

结果测量	措施说明	大体时间
Change From Baseline in Gut Microbiome Shannon Diversity Index 大体时间：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.	Baseline, 3 months, and 6 months after treatment initiation
Change From Baseline in Blood Metabolite Abundance 大体时间：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.	Baseline, 3 months, and 6 months after treatment initiation
Change From Baseline in Blood Protein Abundance 大体时间：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.	Baseline, 3 months, and 6 months after treatment initiation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

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

调查人员

学习椅：Yuexin Cai, Doctor、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2030年10月30日

研究完成 (估计的)

2030年12月30日

研究注册日期

首次提交

2026年8月25日

首先提交符合 QC 标准的

2026年8月28日

首次发布 (实际的)

2026年8月31日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月28日

最后验证

2026年8月1日

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