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

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.

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Key information

Conditions

Tinnitus Acupuncture Auditory Brainstem Response Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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 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.

Primary outcomes

ABR testing

Time frame: Enrolment, Week 5
Tinnitus Handicap Inventory

Time frame: Enrolment, Week 5, Week 13

Secondary outcomes

Tinnitus effects questionnaire

Time frame: Enrolment, Week 5, Week 13

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyu Zhang

CONTACT

[email protected]

86 18357140530

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 13, 2026
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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