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"

NCT06401993 | Recruiting

• 1 other identifier: ZSLL-KY-2024-038-01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Tinnitus

Keywords

Acupuncture; Fnirs; Tinnitus; ABR

Outcome Measures

Primary Outcomes (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

  at baseline (pre-treatment),procedure

Secondary Outcomes (3)

• Tinnitus Evaluation Questionnaire (TEQ)

  at baseline (pre-treatment), procedure

• Auditory Brainstem Response (ABR)

  at baseline (pre-treatment), procedure

• Functional Near-Infrared Spectroscopy (Fnirs)

  at baseline (pre-treatment), procedure

Study Arms (2)

The "dao qi tong luo" group

EXPERIMENTAL

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

Procedure: The "dao qi tong luo" group

The acupuncture group

SHAM COMPARATOR

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

Procedure: The acupuncture group

Interventions

The "dao qi tong luo" group 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 "dao qi tong luo" group

The acupuncture group 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.

The acupuncture group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
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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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40018352 DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jie Zhou, M.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Da Jiang, M.M

CONTACT

18890261521; jddyx2023@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 7, 2024
• Study Start: May 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)