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

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Jun 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for people suffering from chronic tinnitus, which is the perception of sound, like ringing or buzzing, in the ears without any external noise. The trial involves 388 participants who will receive either transcutaneous vagus nerve stimulation combined with personalized music therapy or just the personalized music training alone for three months. The goal is to see which treatment is more effective in reducing the symptoms of tinnitus and to evaluate how well patients stick to the treatment and its safety over time.

To be eligible for the study, participants must be between 18 and 60 years old, have had tinnitus for at least six months, and experience a specific type of sound frequency. However, individuals with certain ear conditions, mental health issues, or a history of head trauma are not eligible. Participants will be closely monitored throughout the study, and their progress will be evaluated before and after treatment, as well as a year later, to determine the lasting effects of the therapies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Hearing threshold at each frequency shall not exceed 70 dB HL
• Exclusion Criteria:
• • 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