Status:
NOT_YET_RECRUITING
Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Zhongshan People's Hospital, Guangdong, China
Conditions:
Tinnitus, Subjective
Vagus Nerve Stimulation
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 ...
Detailed Description
Unified rules for filling in case report forms： * All case report forms must be completed by designated and trained researchers. * Two data managers independently input and proofread the data in dupl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT05417711
Start Date
November 23 2023
End Date
September 1 2026
Last Update
November 27 2023
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