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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

NCT07794462 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2026-08-31

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Subjective Tinnitus

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Yuexin Cai, Doctor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2030-10-30
Completion
2030-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07794462 on ClinicalTrials.gov