NCT06364670

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
May 2024Dec 2026

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

April 10, 2024

Last Update Submit

April 12, 2024

Conditions

Tinnitus

Keywords

acupuncturemoxibustiontinnitusfNIRSmachine learning

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Change in Tinnitus Handicap Inventory score

    at baseline (pre-treatment), after 4-week treatment

  • Change in average pure-tone threshold

    at baseline (pre-treatment), after 4-week treatment

Study Arms (1)

The acupuncture group

EXPERIMENTAL

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

Procedure: acupuncture

Interventions

acupuncturePROCEDURE

Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc.

The acupuncture group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41089742DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Hantong Hu, M.D

    The Third Affiliated hospital of Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohan Huang, M.M

CONTACT

183343347381215360683@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)