Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06364670

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

Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2024-04-15

500

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying tinnitus, a condition involving ringing in the ears, to evaluate how well acupuncture works for patients using advanced brain imaging and machine learning. This study aims to build a model predicting acupuncture's clinical effects on patients with chronic subjective tinnitus by analyzing brain activity data collected through functional near-infrared spectroscopy (fNIRS). The research will involve 500 participants aged 18 to 60 who meet specific diagnostic criteria for tinnitus. Participants will receive acupuncture treatment three times a week for four weeks at specific acupoints, including TE17 (Yifeng), SI19 (Tinggong), and others. Brain imaging data will be collected from all detection channels using fNIRS before and after the acupuncture treatment. Based on their recovery status after treatment, participants will be grouped into "good prognosis" or "poor prognosis" categories. The collected data will be divided into training and test sets to develop the machine learning model. Throughout the study, researchers will assess changes in resting-state functional connectivity, hemoglobin signals, and tinnitus severity grading before and after treatment. Additional measures include the Tinnitus Handicap Inventory score and pure-tone hearing thresholds. Participants will be monitored for treatment response and safety during the 4-week acupuncture course, with data collected at baseline and post-treatment to evaluate outcomes and build predictive models.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

You will not qualify if you...

  • Participants with objective tinnitus.
  • Participants with nervous system or neuropsychiatric diseases affecting brain blood oxygen metabolism.
  • Participants with severe cardiovascular, cerebrovascular, malignant liver, kidney diseases, or other serious illnesses.
  • Participants with contraindications for acupuncture, such as bleeding tendencies.
  • Pregnant or lactating women.
  • Participants who received tinnitus treatment with drugs or other therapies in the last four weeks.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive acupuncture treatment 3 times a week for 4 weeks to evaluate its efficacy in treating tinnitus.

12 visits (in-person)

Trial Site Locations

Total: 1 location

1

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

X

Xiaohan Huang, M.M

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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.

Xiaohan Huang, Da Jiang, Debiao Kong...

https://pubmed.ncbi.nlm.nih.gov/41089742