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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

28 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

444

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
      • Shanghai, China
        • Eye & ENT Hospital, Fudan University
        • Contato:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contato:
      • Huizhou, Guangdong, China
        • Huizhou First People's Hospital
        • Contato:
      • Jieyang, Guangdong, China
        • Jieyang People's Hospital
        • Contato:
      • Zhongshan, Guangdong, China
        • Zhongshan City People's Hospital
        • Contato:
      • Zhuhai, Guangdong, China, 519000
        • Zhuhai Integrated Traditional Chinese and Western Medicine Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.
Comparador Falso: 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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Effective Rate of Tinnitus Improvement at 3 Months
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Effective Rate of Tinnitus Improvement at 6 and 12 Months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Gut Microbiome Shannon Diversity Index
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

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

Investigadores

  • Cadeira de estudo: Yuexin Cai, Doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

30 de outubro de 2030

Conclusão do estudo (Estimado)

30 de dezembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

25 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de agosto de 2026

Primeira postagem (Real)

31 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • SYSKY-2025-917-02

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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