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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"

ConditionTinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • The "dao qi tong luo" group

    Procedure/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 group

    Procedure/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.

Treatment groups

87 Participants
are divided into 2 treatment groups
Group A: The "dao qi tong luo" groupExperimental treatment 1 intervention
Group B: The acupuncture groupSham comparator 1 intervention

Trial outcomes

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

Time frame
at baseline (pre-treatment),procedure

Secondary outcomes

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

Time frame
at baseline (pre-treatment), procedure
2

Auditory Brainstem Response (ABR)

Auditory Brainstem Response is based on relevant expert consensus

Time frame
at baseline (pre-treatment), procedure
3

Functional Near-Infrared Spectroscopy (Fnirs)

Functional Near-Infrared Spectroscopy is based on relevant expert consensus

Time frame
at baseline (pre-treatment), procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Third Affiliated hospital of Zhejiang Chinese Medical University

Lead sponsor

Source ClinicalTrials.gov
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