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

Summary

This clinical study is a prospective, multicenter, randomized, controlled, double-blind clinical study. Sun Yat Sen Memorial Hospital of Sun Yat sen University was the central unit, and Nanjing First Hospital, Sun Yat Sen people's Hospital, Guanfzhou Panyu central Hospital and Zhuhai integrated traditional Chinese and Western medicine hospital were the cooperative units. In this study, 388 patients with chronic subjective tinnitus were recruited. In view of chronic subjective tinnitus, a common ear disease, the study gave the patients three months of treatment with transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy or tailor-made notched music training alone. By comparing the changes of subjective scale scores related to tinnitus before and after treatment in patients receiving two different therapies, such as THI, VAS, BAI, BDI, PSQI, to evaluate the efficacy of the two therapies, so as to judge whether transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy is better than tailor-made notched music training alone. In addition, the study will continue to follow up the patients after the treatment for one year to observe the difference in the long-term sustained efficacy of the two therapies. This clinical study will also evaluate the two therapies from the perspective of compliance and safety, and explore the factors that affect the efficacy of the two therapies.

Conditions

• Tinnitus, Subjective
• Vagus Nerve Stimulation
• Music Therapy
• Double-Blind Method
• Female
• Male
• Humans
• Treatment 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Affiliated Zhuhai Hospital of Southern Medical University

  collaborator UNKNOWN

• Guangzhou Panyu Central Hospital

  collaborator OTHER

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

  collaborator UNKNOWN

• Eighth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Yuexin Cai Cai · 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

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-23

Primary Completion

2026-01-01

Completion

2026-09-01