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

T

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status

Enrolling

Conditions

Tinnitus

Treatments

Procedure: acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06364670
ZSLL-KY-2023-011-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

The acupuncture group
Experimental group
Description:
Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.
Treatment:
Procedure: acupuncture

Trial contacts and locations

1

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Central trial contact

Xiaohan Huang, M.M

Data sourced from clinicaltrials.gov

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