Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
2026년 8월 28일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
444
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yuexin Cai, Doctor
- 전화번호: 86+13825063663
- 이메일: caiyx25@mail.sysu.edu.cn
연구 연락처 백업
- 이름: Qianhui Xu, MD
- 전화번호: 86+13719908396
- 이메일: xuqh9@mail2.sysu.edu.cn
연구 장소
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Shanghai, 중국
- Eye & ENT Hospital, Fudan University
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연락하다:
- Shan Sun
- 전화번호: 86+18917786102
- 이메일: Shansun@fudan.edu.cn
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Guangdong
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Guangzhou, Guangdong, 중국, 510120
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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연락하다:
- Qianhui Xu, MD
- 전화번호: 13719908396
- 이메일: xuqh9@mail2.sysu.edu.cn
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Huizhou, Guangdong, 중국
- Huizhou First People's Hospital
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연락하다:
- Jia Fu
- 전화번호: +86 15820715830
- 이메일: Jiaggfu1985@163.com
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Jieyang, Guangdong, 중국
- Jieyang People's Hospital
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연락하다:
- Jiongcong Yuan
- 전화번호: +86 13480311910
- 이메일: jiongcongyuan@126.com
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Zhongshan, Guangdong, 중국
- Zhongshan City People's Hospital
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연락하다:
- Guoping Chen
- 전화번호: 86+15019918918
- 이메일: cgping345@163.com
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Zhuhai, Guangdong, 중국, 519000
- Zhuhai Integrated Traditional Chinese and Western Medicine Hospital
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연락하다:
- Binbin Xiong
- 전화번호: 86+13926935096
- 이메일: xiongbb2015@126.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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가짜 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effective Rate of Tinnitus Improvement at 3 Months
기간: Baseline and 3 months after treatment initiation
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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%.
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Baseline and 3 months after treatment initiation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effective Rate of Tinnitus Improvement at 6 and 12 Months
기간: Baseline, 6 months, and 12 months after treatment initiation
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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%.
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Baseline, 6 months, and 12 months after treatment initiation
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Change in Visual Analog Scale (VAS) Score for Tinnitus Loudness
기간: Baseline, 3 months, 6 months, and 12 months after treatment initiation
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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.
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Baseline, 3 months, 6 months, and 12 months after treatment initiation
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Change in Acoustic Tinnitus Match Loudness
기간: Baseline, 3 months, 6 months, and 12 months after treatment initiation
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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.
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Baseline, 3 months, 6 months, and 12 months after treatment initiation
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Change in Beck Anxiety Inventory (BAI) Score
기간: Baseline, 3 months, 6 months, and 12 months after treatment initiation
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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.
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Baseline, 3 months, 6 months, and 12 months after treatment initiation
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Change in Beck Depression Inventory (BDI) Score
기간: Baseline, 3 months, 6 months, and 12 months after treatment initiation
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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.
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Baseline, 3 months, 6 months, and 12 months after treatment initiation
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Change in Pittsburgh Sleep Quality Index (PSQI) Score
기간: Baseline, 3 months, 6 months, and 12 months after treatment initiation
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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.
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Baseline, 3 months, 6 months, and 12 months after treatment initiation
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Change in Resting-State EEG Features
기간: Baseline, 3 months, and 6 months after treatment initiation
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Change in resting-state EEG features, including power spectrum entropy and oscillatory characteristics, from baseline to post-treatment and follow-up.
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Baseline, 3 months, and 6 months after treatment initiation
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Change in MRI Features
기간: Baseline, 3 months, and 6 months after treatment initiation
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Change in MRI features from baseline to post-treatment and follow-up.
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Baseline, 3 months, and 6 months after treatment initiation
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Safety Outcomes: Incidence of Treatment-Related Adverse Events
기간: From treatment initiation through 3 months (end of treatment)
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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%.
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From treatment initiation through 3 months (end of treatment)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Gut Microbiome Shannon Diversity Index
기간: Baseline, 3 months, and 6 months after treatment initiation
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Gut microbial alpha diversity will be assessed using the Shannon diversity index in stool samples collected at baseline, 3 months, and 6 months.
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Baseline, 3 months, and 6 months after treatment initiation
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Change From Baseline in Blood Metabolite Abundance
기간: Baseline, 3 months, and 6 months after treatment initiation
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Blood metabolite abundance will be assessed at baseline, 3 months, and 6 months using metabolomic profiling.
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Baseline, 3 months, and 6 months after treatment initiation
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Change From Baseline in Blood Protein Abundance
기간: Baseline, 3 months, and 6 months after treatment initiation
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Blood protein abundance will be assessed at baseline, 3 months, and 6 months using proteomic profiling.
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Baseline, 3 months, and 6 months after treatment initiation
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수사관
- 연구 의자: Yuexin Cai, Doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2030년 10월 30일
연구 완료 (추정된)
2030년 12월 30일
연구 등록 날짜
최초 제출
2026년 8월 25일
QC 기준을 충족하는 최초 제출
2026년 8월 28일
처음 게시됨 (실제)
2026년 8월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 31일
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2026년 8월 28일
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2026년 8월 1일
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- SYSKY-2025-917-02
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아니요
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