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
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