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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06401993
Other study ID # ZSLL-KY-2024-038-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date December 2026

Study information

Verified date May 2024
Source The Third Affiliated hospital of Zhejiang Chinese Medical University
Contact Da Jiang, M.M
Phone 18890261521
Email jddyx2023@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 87
Est. completion date December 2026
Est. primary completion date August 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria: - Inclusion criteria for patients with chronic tinnitus 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; 6. Normal expression and understanding ability. Inclusion criteria for healthy subjects 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
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.

Locations

Country Name City State
China The Third Affiliated Hospital of Zhejiang Chinese Medical University Hangzhou

Sponsors (1)

Lead Sponsor Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 at baseline (pre-treatment), procedure
Secondary Auditory Brainstem Response (ABR) Auditory Brainstem Response is based on relevant expert consensus at baseline (pre-treatment), procedure
Secondary Functional Near-Infrared Spectroscopy (Fnirs) Functional Near-Infrared Spectroscopy is based on relevant expert consensus at baseline (pre-treatment), procedure
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