Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus

Not Applicable

Recruiting

• Conditions: Tinnitus
• Interventions: Procedure: acupuncture

• Registration Number: NCT06364670
• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Study Start: 2024-05
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus.
• Male and female, aged between 18 and 60 years.
• Right-handed subjects who are able to comply with the study protocol and sign written informed consent.
• Not participating in other clinical trials concurrently.

Exclusion Criteria

• Participants with objective tinnitus.
• Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by fNIRS.
• Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases.
• Participants have any contraindications for acupuncture (such as a bleeding tendency).
• Pregnant or lactating women.
• Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The acupuncture group	acupuncture	Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Tinnitus Severity Grading	at baseline (pre-treatment), after 4-week treatment	Tinnitus Severity Grading is based on relevant expert consensus.
Change in hemoglobin signals	at baseline (pre-treatment), after 4-week treatment	Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
Change in resting-state functional connectivity (RSFC)	at baseline (pre-treatment), after 4-week treatment	RSFC will be measured by functional near-infrared spectroscopy (fNIRS).

Secondary Outcome Measures

Name	Time	Method
Change in Tinnitus Handicap Inventory score	at baseline (pre-treatment), after 4-week treatment	Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus.
Change in average pure-tone threshold	at baseline (pre-treatment), after 4-week treatment	The average pure-tone threshold will be assessed by pure-tone audiometry.

Trial Locations

Locations (1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China