Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
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.
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Yuexin Cai, Doctor
- Puhelinnumero: 86+13825063663
- Sähköposti: caiyx25@mail.sysu.edu.cn
Tutki yhteystietojen varmuuskopiointi
- Nimi: Qianhui Xu, MD
- Puhelinnumero: 86+13719908396
- Sähköposti: xuqh9@mail2.sysu.edu.cn
Opiskelupaikat
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Shanghai, Kiina
- Eye & ENT Hospital, Fudan University
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Ottaa yhteyttä:
- Shan Sun
- Puhelinnumero: 86+18917786102
- Sähköposti: Shansun@fudan.edu.cn
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Guangdong
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Guangzhou, Guangdong, Kiina, 510120
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Ottaa yhteyttä:
- Qianhui Xu, MD
- Puhelinnumero: 13719908396
- Sähköposti: xuqh9@mail2.sysu.edu.cn
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Huizhou, Guangdong, Kiina
- Huizhou First People's Hospital
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Ottaa yhteyttä:
- Jia Fu
- Puhelinnumero: +86 15820715830
- Sähköposti: Jiaggfu1985@163.com
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Jieyang, Guangdong, Kiina
- Jieyang People's Hospital
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Ottaa yhteyttä:
- Jiongcong Yuan
- Puhelinnumero: +86 13480311910
- Sähköposti: jiongcongyuan@126.com
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Zhongshan, Guangdong, Kiina
- Zhongshan City People's Hospital
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Ottaa yhteyttä:
- Guoping Chen
- Puhelinnumero: 86+15019918918
- Sähköposti: cgping345@163.com
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Zhuhai, Guangdong, Kiina, 519000
- Zhuhai Integrated Traditional Chinese and Western Medicine Hospital
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Ottaa yhteyttä:
- Binbin Xiong
- Puhelinnumero: 86+13926935096
- Sähköposti: xiongbb2015@126.com
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Kokeellinen: 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.
|
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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|
Huijausvertailija: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Effective Rate of Tinnitus Improvement at 3 Months
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Effective Rate of Tinnitus Improvement at 6 and 12 Months
Aikaikkuna: 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%.
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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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Muut tulostoimenpiteet
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change From Baseline in Gut Microbiome Shannon Diversity Index
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Opintojen puheenjohtaja: Yuexin Cai, Doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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