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This trial aims to use machine learning to analyze fNIRS imaging data of specific brain regions of tinnitus patients, thereby constructing a predictive model of the clinical efficacy of acupuncture for SNT.
This study will recruit 500 subjects with tinnitus. Functional near-infrared spectroscopy (fNIRS) will be employed to examine specific brain regions, and the corresponding fNIRS imaging data from all detection channels will be extracted. Subsequently, the subjects will undergo a course of acupuncture treatment. Based on the recovery status of tinnitus at the conclusion of the acupuncture course, all subjects will be categorized into a "good prognosis group" and a "poor prognosis group" according to relevant efficacy criteria. The entire dataset will then be randomly divided into a training set (70%) and a test set (30%) following a 7:3 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The acupuncture group | Experimental | Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Procedure | Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in resting-state functional connectivity (RSFC) | RSFC will be measured by functional near-infrared spectroscopy (fNIRS). | at baseline (pre-treatment), after 4-week treatment |
| Change in hemoglobin signals | Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS). | at baseline (pre-treatment), after 4-week treatment |
| Change in Tinnitus Severity Grading | Tinnitus Severity Grading is based on relevant expert consensus. | at baseline (pre-treatment), after 4-week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tinnitus Handicap Inventory score | Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus. | at baseline (pre-treatment), after 4-week treatment |
| Change in average pure-tone threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohan Huang, M.M | Contact | 18334334738 | 86 | 1215360683@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Hantong Hu, M.D | The Third Affiliated hospital of Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third Affiliated Hospital of Zhejiang Chinese Medical University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41089742 | Derived | Huang X, Jiang D, Kong D, Liu H, Chen L, Li Y, Zhou J, Gao H, Hu H. Predicting Individual Response to Acupuncture in Sensorineural Tinnitus Using Integrated Functional Near-Infrared Spectroscopy and Machine Learning: Protocol for a Model Development and Validation Study. J Multidiscip Healthc. 2025 Oct 9;18:6579-6593. doi: 10.2147/JMDH.S550296. eCollection 2025. |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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The average pure-tone threshold will be assessed by pure-tone audiometry. |
| at baseline (pre-treatment), after 4-week treatment |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |