Clinical trial NCT06364670: Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus
Official title: Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: acupuncture
moxibustion
tinnitus
fNIRS
machine learning
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in resting-state functional connectivity (RSFC)
timeFrame: at baseline (pre-treatment), after 4-week treatment
measure: Change in hemoglobin signals
timeFrame: at baseline (pre-treatment), after 4-week treatment
measure: Change in Tinnitus Severity Grading
timeFrame: at baseline (pre-treatment), after 4-week treatment
Secondary outcomes:
measure: Change in Tinnitus Handicap Inventory score
timeFrame: at baseline (pre-treatment), after 4-week treatment
measure: Change in average pure-tone threshold
timeFrame: at baseline (pre-treatment), after 4-week treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Hantong Hu, M.D
role: PRINCIPAL_INVESTIGATOR
References: