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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 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

444

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore fittizio: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effective Rate of Tinnitus Improvement at 3 Months
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effective Rate of Tinnitus Improvement at 6 and 12 Months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Gut Microbiome Shannon Diversity Index
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Investigatori

  • Cattedra di studio: Yuexin Cai, Doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

30 ottobre 2030

Completamento dello studio (Stimato)

30 dicembre 2030

Date di iscrizione allo studio

Primo inviato

25 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 agosto 2026

Primo Inserito (Effettivo)

31 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SYSKY-2025-917-02

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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