NCT07522567

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Dec 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

December 31, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 4, 2026

Last Update Submit

April 4, 2026

Conditions

AcupunctureAuditory Brainstem ResponseTinnitus

Keywords

tinnitusacupunctureauditory brainstem response

Outcome Measures

Primary Outcomes (2)

  • ABR testing

    Enrolment, Week 5

  • Tinnitus Handicap Inventory

    Enrolment, Week 5, Week 13

Secondary Outcomes (1)

  • Tinnitus effects questionnaire

    Enrolment, Week 5, Week 13

Study Arms (1)

Acupuncture group

EXPERIMENTAL
Other: Acupuncture

Interventions

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.

Acupuncture group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tinnitus

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Shiyu Zhang

CONTACT

86 18357140530zsy001026zsy@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident physician

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start (Estimated)

December 31, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04