TinnitusNCT06364670
Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus
A study testing acupuncture in people with Tinnitus, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Hantong Hu, M.D, 18667103032 ext. 86, 413351308@qq.com
Xiaohan Huang, M.M, 18334334738 ext. 86, 1215360683@qq.com
About this study
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- acupuncture
- Keywords
- acupuncture, moxibustion, tinnitus, fNIRS, machine learning
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc.
| Study group | Role | What they receive |
|---|---|---|
| The acupuncture group | Experimental | Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks. Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting-state functional connectivity (RSFC)
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
Measured: at baseline (pre-treatment), after 4-week treatment
Change in hemoglobin signals
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
Measured: at baseline (pre-treatment), after 4-week treatment
Change in Tinnitus Severity Grading
Tinnitus Severity Grading is based on relevant expert consensus.
Measured: at baseline (pre-treatment), after 4-week treatment
Secondary outcomes (2)
Change in Tinnitus Handicap Inventory score
Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus.
Measured: at baseline (pre-treatment), after 4-week treatment
Change in average pure-tone threshold
The average pure-tone threshold will be assessed by pure-tone audiometry.
Measured: at baseline (pre-treatment), after 4-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startMay 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hantong Hu, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Hantong Hu, M.D, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364670
- Sponsor's protocol ID
- ZSLL-KY-2023-011-01
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41089742
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus
- ClinicalTrials.gov ID
- NCT06364670
- Acronym / sponsor ID
- ZSLL-KY-2023-011-01
- Conditions
- Tinnitus
- Keywords
- acupuncture, moxibustion, tinnitus, fNIRS, machine learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The acupuncture group | Experimental | Procedure: acupunctureSubjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAcupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc. | Procedure or surgery | The acupuncture group |
Primary outcome
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).
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).
Change in Tinnitus Severity Grading
Time frame: at baseline (pre-treatment), after 4-week treatment
Tinnitus Severity Grading is based on relevant expert consensus.
2 secondary outcomes
Change in Tinnitus Handicap Inventory score
Time frame: at baseline (pre-treatment), after 4-week treatment
Change in average pure-tone threshold
Time frame: at baseline (pre-treatment), after 4-week treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 41089742Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hantong Hu, M.D principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Tinnitus, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohan Huang, M.M (18334334738 ext. 86, 1215360683@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting-state functional connectivity (RSFC) (time frame: at baseline (pre-treatment), after 4-week treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06364670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.