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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

Qualifiers

Patients with tinnitus as the main complaint: the patients subjectively feel the sound in the ear or deep part of the head without internal or external sound stimulation, and therefore seek medical treatment

Chronic (≥ 6 months) and tonal tinnitus

Age 18-60

Tinnitus frequency is 125-8000 Hz

Disqualifiers

Patients with conductive deafness, history of middle ear surgery, pulsatile tinnitus caused by vascular distortion and tinnitus caused by Meniere disease

History of head trauma, central nervous system diseases, mental diseases and drug abuse

Trial design

Treatments tested in this trial

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

Treatment groups

388 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

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

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Zhongshan People's Hospital, Guangdong, China

Collaborator

Affiliated Zhuhai Hospital of Southern Medical University

Collaborator

Guangzhou Panyu Central Hospital

Collaborator

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

Collaborator

Eighth Affiliated Hospital, Sun Yat-sen University

Collaborator

Second Affiliated Hospital of Guangzhou Medical University

Collaborator

Southern Medical University, China

Collaborator