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TinnitusNCT06401993

Peripheral-central Correlation Study on the Treatment of Chronic Tinnitus With "Dao qi Tong Luo" Based on the Theory of "Connecting the Two Ears to the Brain"

A study testing The "dao qi tong luo" group and The acupuncture group in people with Tinnitus, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

By comparing the clinical manifestations, ABR parameters and cerebral cortex blood oxygen levels of chronic tinnitus patients and healthy subjects under two different body states, the peripheral-central correlation of chronic tinnitus patients was explored, and the modern scientific significance of the theory of "two… Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Tinnitus
What is being tested?
The "dao qi tong luo" group and The acupuncture group
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
1 siteChina
Study dates
4 May 2024to Dec 2026
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 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chronic tinnitus patients, that is, the course of disease ≥6 months;
  • No contraindications of fNIRS scanning;
  • The age of 20 years ≤55 years old, gender is not limited, right-handed;
  • The external ear canal is unobstructed and the eardrum is intact
  • The average hearing threshold of both ears is <35dB;
  • Normal expression and understanding ability. Inclusion criteria for healthy subjects
Show all 13Show fewer
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  • No tinnitus, no hearing disorders and other ear diseases;
  • Good health condition, no history of mental disease and nervous system disease;
  • No contraindications of fNIRS scanning;
  • The age of 20 years ≤55 years old, gender is not limited, right-handed;
  • The external ear canal is unobstructed, and the tympanic membrane is complete;
  • Normal expression and understanding ability.

Who cannot join

  • 1.A history of drug dependence or alcohol addiction; 2.Serious central system diseases or other systemic diseases such as cardiovascular and cerebrovascular diseases; 3. Patients with organic diseases such as craniocerebral trauma; 4. Sudden deafness, Meniere's disease, otosclerosis, acoustic neuroma and other inner ear or auditory nerve diseases; 5.External otitis, acute/chronic otitis media and other external ear middle-ear related diseases; 6. Patients with auditory hypersensitivity; 7. Pregnancy, preparation for pregnancy, breastfeeding population; 8. There are metal implants in the body, fNIRS detection contraindicated.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Da Jiang, M.M contact

18890261521

jddyx2023@163.com

China1 site, 1 recruiting

  • The Third Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, 310000

    Jie Zhou, M.D, 15968895450, zhoujie0111@yeah.net

    Jie Zhou, M.D

    Recruiting

Other trials in China

About this study

By comparing the clinical manifestations, ABR parameters and cerebral cortex blood oxygen levels of chronic tinnitus patients and healthy subjects under two different body states, the peripheral-central correlation of chronic tinnitus patients was explored, and the modern scientific significance of the theory of "two ears connecting the brain" was initially expounded. On this basis, the immediate and cumulative effects and peripheral-central correlation of "dao qi tong luo" intervention in chronic tinnitus were observed, and the effective mechanism of "dao qi tong luo" treatment was explored.

Read the detailed description

The study will enroll 15 healthy subjects and 72 subjects with chronic tinnitus. Functional near infrared spectroscopy (fNIRS) will be used to examine specific brain regions, and ABR techniques will record auditory brainstem responses in chronic tinnitus patients and healthy subjects. Lateral comparison was made between chronic tinnitus patients and healthy subjects on the parameters of auditory brainstem response and the level of oxygen outside the cerebral cortex, and the data of the two were integrated to conduct correlation analysis and correlation analysis with clinical manifestations, so as to compare the correlation between peripheral and central auditory function in different body states. Subsequently, the chronic tinnitus subjects will undergo a course of acupuncture treatment. At the end of acupuncture and moxibustion treatment, the immediate and cumulative effects and peripheral - central correlation of "dao qi tong luo" intervention in chronic tinnitus were observed, and the effective mechanism of "dao qi tong luo" treatment was explored.

Conditions
Tinnitus
Being tested
The "dao qi tong luo" group, The acupuncture group
Keywords
Acupuncture, Fnirs, Tinnitus, ABR
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The "dao qi tong luo" groupProcedure or surgery

    The "dao qi tong luo" group will accept acpuncture. Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu) and etc. Among them, the "dao qi tong luo" group will make patients feel qi.

  • The acupuncture groupProcedure or surgery

    The acupuncture group will accept acpuncture. Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu) and etc. The acupuncture group will not feel qi.

Study groups in NCT06401993
Study groupRoleWhat they receive
The "dao qi tong luo" groupExperimentalSubjects in the "dao qi tong luo" group will undergo acupuncture treatment, which is administered 10 times
Receives: Procedure: The "dao qi tong luo" group
The acupuncture groupSham comparatorSubjects in the acupuncture group will undergo acupuncture treatment, which is administered 10 times
Receives: Procedure: The acupuncture group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tinnitus Handicap Inventory (THI)

    Tinnitus Handicap Inventory is based on relevant expert consensus. THI scores range from 0 to 100, with the higher the score, the more severe the condition

    Measured: at baseline (pre-treatment),procedure

Secondary outcomes (3)

  1. Tinnitus Evaluation Questionnaire (TEQ)

    Tinnitus Evaluation Questionnaire is based on relevant expert consensus. TEQ scores range from 0 to 21, with the higher the score, the more severe the condition

    Measured: at baseline (pre-treatment), procedure

  2. Auditory Brainstem Response (ABR)

    Auditory Brainstem Response is based on relevant expert consensus

    Measured: at baseline (pre-treatment), procedure

  3. Functional Near-Infrared Spectroscopy (Fnirs)

    Functional Near-Infrared Spectroscopy is based on relevant expert consensus

    Measured: at baseline (pre-treatment), procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start4 May 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401993
Sponsor's protocol ID
ZSLL-KY-2024-038-01
Status last verified
Nov 2024
First submitted
30 Apr 2024
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jiang D, Huang XH, Fang K, Zhao MH, Li Y, Hu HT, Fang LQ, Gao H, Zhou J. Peripheral-central correlation study of acupuncture for chronic tinnitus study protocol for a randomized controlled trial. Front Med (Lausanne). 2025 Feb 13;12:1543023. doi: 10.3389/fmed.2025.1543023. eCollection 2025.

    PubMed 40018352

Questions about this trial

What is this clinical trial studying?

A study testing The "dao qi tong luo" group and The acupuncture group in people with Tinnitus, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.

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 13 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Da Jiang, M.M (18890261521, jddyx2023@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tinnitus Handicap Inventory (THI) (time frame: at baseline (pre-treatment),procedure). 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 NCT06401993, 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 3 Dec 2024.

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