Efficacy of Acupuncture on Chronic Tinnitus and Its Association With Auditory Brainstem Response Measures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture.
- Who it may be relevant to
- Registry conditions: Tinnitus, Acupuncture, Auditory Brainstem Response. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Other Acupuncture
The 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 t
Primary outcome measures
- ABR testing [Time frame: Enrolment, Week 5]
- Tinnitus Handicap Inventory [Time frame: Enrolment, Week 5, Week 13]
Secondary outcome measures (1)
- Tinnitus effects questionnaire [Time frame: Enrolment, Week 5, Week 13]
Eligibility criteria
Inclusion criteria
- Aged between 18 and 60 years, inclusive, any sex;
- No previous chronic functional or organic diseases, no head injury;
- No history of any psychiatric or neurological family genetic disease;
- Signed a paper version of the informed consent form and volunteered to participate in this trial.
Exclusion criteria
- Pregnant or breastfeeding women, and those who have a request for childbearing within the last six months;
- History of head trauma;
- Presence of metallic implants in the body or any other contraindication to ABR testing;
- Current participation in any other interventional clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07522567 · ZSLL-KY-2025-032-01