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Not Yet RecruitingNCT07522567

Efficacy of Acupuncture on Chronic Tinnitus and Its Association With Auditory Brainstem Response Measures

Efficacy of Acupuncture on Chronic Tinnitus and Its Association With Auditory Brainstem Response Measures: A Study Protocol for a Matched Case-Control and Self-Controlled Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
72 (estimated)
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

The goal of this clinical trial is to learn if acupuncture works to treat chronic tinnitus in adults. It will also learn about the neurophysiological effects of acupuncture on auditory conduction pathway function. The main questions it aims to answer are: Does acupuncture lower tinnitus-related disability and severity, as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Effects Questionnaire (TEQ)? What changes in auditory brainstem response (ABR) parameters-such as wave I amplitude and wave V latency-occur after acupuncture treatment, and do these changes correlate with clinical improvement? Researchers will compare ABR parameters and clinical outcomes between chronic tinnitus patients and age- and sex-matched healthy controls to characterize tinnitus-related abnormalities. Additionally, the study will evaluate changes within the patient group before and after a 10-session acupuncture course to assess treatment efficacy and explore its neurophysiological mechanisms.

Conditions

Interventions

TypeNameDescription
OTHERAcupunctureThe acupoint prescription for this study was developed based on the clinical experience of senior acupuncturists and findings from previous related studies. The selected acupoints are as follow: Yifeng(both sides)、Tinggong(both sides)、Tinghui(both sides)、Zhongwan、Xiawan、Qihai、Guanyuan、Yindu(both sides),Shangqu(both sides)、Huaroumen(both sides). The aforementioned acupoints will be needled on both sides because all recruited individuals have bilateral tinnitus. Licensed acupuncturists with over ten years of clinical experience in acupuncture and moxibustion will perform all treatments. All chronic tinnitus patients will receive a total of 10 acupuncture sessions, administered once every two days (three times per week) over a period of four weeks. Based on our prior research and clinical experience using acupuncture to treat tinnitus, we decided 10 acupuncture sessions in total.

Timeline

Start date
2026-12-31
Primary completion
2027-06-01
Completion
2027-07-31
First posted
2026-04-13
Last updated
2026-04-13

Source: ClinicalTrials.gov record NCT07522567. Inclusion in this directory is not an endorsement.