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NCT Number: NCT06364670

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Hantong Hu, M.D

CONTACT

[email protected]

18667103032 ext. 86

Hantong Hu, M.D

PRINCIPAL_INVESTIGATOR

Xiaohan Huang, M.M

CONTACT

[email protected]

18334334738 ext. 86

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in resting-state functional connectivity (RSFC)

    Time frame: at baseline (pre-treatment), after 4-week treatment

    RSFC will be measured by functional near-infrared spectroscopy (fNIRS).

  2. Change in hemoglobin signals

    Time frame: at baseline (pre-treatment), after 4-week treatment

    Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).

  3. Change in Tinnitus Severity Grading

    Time frame: at baseline (pre-treatment), after 4-week treatment

    Tinnitus Severity Grading is based on relevant expert consensus.

Secondary outcomes

  1. Change in Tinnitus Handicap Inventory score

    Time frame: 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.

  2. Change in average pure-tone threshold

    Time frame: at baseline (pre-treatment), after 4-week treatment

    The average pure-tone threshold will be assessed by pure-tone audiometry.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaohan Huang, M.M

CONTACT

[email protected]

18334334738 ext. 86

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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