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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"

NCT ID: NCT06401993

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-04

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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The "dao qi tong luo" group

Subjects in the "dao qi tong luo" group will undergo acupuncture treatment, which is administered 10 times

Group Type EXPERIMENTAL

The "dao qi tong luo" group

Intervention Type PROCEDURE

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 group

Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 10 times

Group Type SHAM_COMPARATOR

The acupuncture group

Intervention Type PROCEDURE

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.

Interventions

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The "dao qi tong luo" group

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.

Intervention Type PROCEDURE

The acupuncture group

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Chronic tinnitus patients, that is, the course of disease ≥6 months;
2. No contraindications of fNIRS scanning;
3. The age of 20 years ≤55 years old, gender is not limited, right-handed;
4. The external ear canal is unobstructed and the eardrum is intact
5. The average hearing threshold of both ears is \<35dB;

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1. No tinnitus, no hearing disorders and other ear diseases;
2. Good health condition, no history of mental disease and nervous system disease;
3. No contraindications of fNIRS scanning;
4. The age of 20 years ≤55 years old, gender is not limited, right-handed;
5. The external ear canal is unobstructed, and the tympanic membrane is complete;
6. Normal expression and understanding ability.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jie Zhou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Zhou, M.D

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Locations

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The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Da Jiang, M.M

Role: CONTACT

[email protected]
18890261521

Facility Contacts

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Jie Zhou, M.D

Role: primary

[email protected]
15968895450

References

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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.

Reference Type DERIVED
PMID: 40018352 (View on PubMed)

Other Identifiers

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ZSLL-KY-2024-038-01

Identifier Type: -

Identifier Source: org_study_id