TinnitusNCT07522567
Efficacy of Acupuncture on Chronic Tinnitus and Its Association With Auditory Brainstem Response Measures
A study testing Acupuncture in people with Tinnitus and Acupuncture, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Acupuncture, Auditory Brainstem Response
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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)?
Read more
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
- Tinnitus, Acupuncture, Auditory Brainstem Response
- Being tested
- Acupuncture
- Keywords
- tinnitus, acupuncture, auditory brainstem response
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Not described Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABR testing
Measured: Enrolment, Week 5
Tinnitus Handicap Inventory
Measured: Enrolment, Week 5, Week 13
Secondary outcomes (1)
Tinnitus effects questionnaire
Measured: Enrolment, Week 5, Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyu Zhang, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522567
- Sponsor's protocol ID
- ZSLL-KY-2025-032-01
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang S, Zhao M, Chen K, Xu S, Ye K, Fang L, Gao H. Acupuncture for chronic tinnitus: study protocol for a clinical trial with auditory brainstem response outcomes. Front Neurol. 2026 Sep 10;17:1928456. doi: 10.3389/fneur.2026.1928456. eCollection 2026.
PubMed 42787075
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07522567
- Acronym / sponsor ID
- ZSLL-KY-2025-032-01
- Conditions
- Tinnitus, Acupuncture, Auditory Brainstem Response
- Keywords
- tinnitus, acupuncture, auditory brainstem response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupuncture |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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. | Other | Acupuncture group |
Primary outcome
ABR testing
Time frame: Enrolment, Week 5
Tinnitus Handicap Inventory
Time frame: Enrolment, Week 5, Week 13
1 secondary outcome
Tinnitus effects questionnaire
Time frame: Enrolment, Week 5, Week 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42787075Zhang S, Zhao M, Chen K, Xu S, Ye K, Fang L, Gao H. Acupuncture for chronic tinnitus: study protocol for a clinical trial with auditory brainstem response outcomes. Front Neurol. 2026 Sep 10;17:1928456. doi: 10.3389/fneur.2026.1928456. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Tinnitus and Acupuncture, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyu Zhang (86 18357140530, zsy001026zsy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABR testing (time frame: Enrolment, Week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.