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NCT Number: NCT06401993

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"

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, 310000, China

Location status: Recruiting

Location contact

Jie Zhou, M.D

CONTACT

[email protected]

15968895450

Jie Zhou, M.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria for patients with chronic tinnitus
  • 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

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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.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Tinnitus Handicap Inventory (THI)

    Time frame: at baseline (pre-treatment),procedure

    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

Secondary outcomes

  1. Tinnitus Evaluation Questionnaire (TEQ)

    Time frame: at baseline (pre-treatment), procedure

    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

  2. Auditory Brainstem Response (ABR)

    Time frame: at baseline (pre-treatment), procedure

    Auditory Brainstem Response is based on relevant expert consensus

  3. Functional Near-Infrared Spectroscopy (Fnirs)

    Time frame: at baseline (pre-treatment), procedure

    Functional Near-Infrared Spectroscopy is based on relevant expert consensus

Study contacts

Contact information is provided by the study sponsor or research team.

Da Jiang, M.M

CONTACT

[email protected]

18890261521

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 7, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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