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

StatusUnknown
PhaseNot applicable
Started2023-11-23
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 27, 2023 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Not Yet Recruiting → Unknown
2023-11-22
minor
Study Status v2
Trial statusNot Yet Recruiting→Unknown
Start date2023-01-01→2023-11-23
2022-11-17
minor
Study Status, Sponsor/Collaborators v1
Primary completion date2025-07-01→2026-01-01
Completion date2027-07-01→2026-09-01
Start date2022-07-01→2023-01-01
Collaborators4 to 7 entries
Eighth Affiliated Hospital, Sun Yat-sen University Second Affiliated Hospital of Guangzhou Medical University Southern Medical University, China
2022-06-09
minor
Original filing
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.
Trial Details
NCT Number NCT05417711
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: The First Affiliated Hospital with Nanjing Medical University, Zhongshan People's Hospital, Guangdong, China, Affiliated Zhuhai Hospital of Southern Medical University, Guangzhou Panyu Central Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Second Affiliated Hospital of Guangzhou Medical University, Southern Medical University, China
Conditions Tinnitus, Subjective, Vagus Nerve Stimulation, Music Therapy, Double-Blind Method, Female, Male, Humans, Treatment Outcome
Enrollment 388 participants
Start Date 2023-11-23
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2023-11-27