Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus

NANot yet recruitingINTERVENTIONAL
Enrollment

388

Participants

Timeline

Start Date

November 23, 2023

Primary Completion Date

January 1, 2026

Study Completion Date

September 1, 2026

Conditions
Tinnitus, SubjectiveVagus Nerve StimulationMusic TherapyDouble-Blind MethodFemaleMaleHumansTreatment Outcome
Interventions
DEVICE

Transcutaneous Vagus Nerve Stimulation Paired with Tailor-Made Notched Music Therapy

The pulse frequency of vagus nerve stimulation is 25 Hz, the pulse width is 200 US, and the intensity is 1-10 mA. Tailor-made notched music is produced by filtering a frequency band of 1/2 octave width centered at the individual tinnitus frequency. When two sides of tinnitus frequencies are different, each side of music are filtered respectively, according to the different tinnitus frequency. When only have unilateral tinnitus or bilateral tinnitus in the same central frequency, both sides of music are filtered with the same tinnitus frequency. The tVNS and TMNM begin at the same time during treatment.

DEVICE

Tailor-made Notched Music Training

Tailor-made notched music is produced by filtering a frequency band of 1/2 octave width centered at the individual tinnitus frequency. When two sides of tinnitus frequencies are different, each side of music are filtered respectively, according to the different tinnitus frequency. When only have unilateral tinnitus or bilateral tinnitus in the same central frequency, both sides of music are filtered with the same tinnitus frequency. At the beginning of TMNMT, 10 seconds sham vagus nerve stimulation is output, whose parameters are as same as experimental group.

All Listed Sponsors
collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

collaborator

Affiliated Zhuhai Hospital of Southern Medical University

UNKNOWN

collaborator

Guangzhou Panyu Central Hospital

OTHER

collaborator

Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University

UNKNOWN

collaborator

Eighth Affiliated Hospital, Sun Yat-sen University

OTHER

collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

collaborator

Southern Medical University, China

OTHER

lead

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

OTHER

NCT05417711 - Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus | Biotech Hunter | Biotech Hunter