TinnitusNCT07383675
A Multicenter Cross-sectional Study on Tinnitus Subtypes and Risk Factors
An observational study of Tinnitus, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Tinnitus affects an estimated 10-15% of the global population and can substantially impair quality of life, yet clinically actionable approaches for subtype identification and risk stratification remain limited. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Observational group
- How many people
- 3,345 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 16 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with any type of tinnitus from three otolaryngology specialty hospitals in China
Who may be able to join
- ≥18 years old；
- Patients diagnosed with various types of tinnitus；
- Patients with available electronic medical records, including demographic and clinical information.
Who cannot join
- Patients with incomplete data；
- Patients with severe neurological；
- Patients with disorders that may confound tinnitus assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EHR-Based Risk Factors With Prediction Models for Tinnitus Subtypes: A Multicenter Cross-sectional Study
Tinnitus affects an estimated 10-15% of the global population and can substantially impair quality of life, yet clinically actionable approaches for subtype identification and risk stratification remain limited. This multicenter, cross-sectional observational study will use de-identified electronic health record (EHR) data from three otolaryngology specialty hospitals in China to address these gaps. All extracted data will be de-identified with direct identifiers removed, and privacy safeguards will be implemented in accordance with institutional policies and applicable regulations to protect patient confidentiality.
Read the detailed description
Using a prespecified, clinically informed framework, we will classify tinnitus into relevant subtypes, including somatosensory tinnitus, acute vs. chronic tinnitus, pulsatile tinnitus, and sudden hearing loss-related tinnitus. We will first describe the distribution of these subtypes and characterize their demographic, clinical, and laboratory profiles. We will then evaluate associations between candidate risk factors and subtype membership using multivariable analyses to quantify adjusted effects. Finally, we will develop and validate multivariable prediction models using both conventional statistical approaches and machine learning methods to support tinnitus subtype classification. Model performance will be assessed using discrimination, calibration, and clinical utility metrics. By integrating routine clinical data with biomarker information captured in real-world care, this study aims to provide evidence-based tools to improve tinnitus subtype diagnosis and enable more personalized clinical assessment.
- Conditions
- Tinnitus
- Being tested
- Observational group
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational groupOther
This is a multicenter, cross-sectional observational study using existing electronic health record data collected during routine clinical care.We will use retrospectively extracted electronic health record data from multiple otolaryngology specialty hospitals to identify risk factors and develop predictive models for tinnitus subtypes at a single index time point.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each Tinnitus Subtype
The number of participants classified into each predefined tinnitus subtype based on an integrated diagnosis clinical classification framework.
Measured: baseline
Secondary outcomes (2)
Adjusted odds ratios of risk factors associated with each tinnitus subtype
Multivariable logistic regression-derived odds ratios quantifying the independent association between risk factors and specific tinnitus subtypes.
Measured: baseline
Accuracy of prediction models for identifying tinnitus subtype classification
The diagnostic performance of a multimodal classification model for identifying tinnitus subtype. The model integrates clinical characteristics, laboratory parameters, and computed tomography imaging features. Tinnitus subtype, determined by physician medical diagnosis, serves as the reference standard. Model performance will be quantified using the area under the receiver operating characteristic curve (AUC). The unit of measure is Area under the ROC curve (AUC).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Mar 2022
- Primary completion30 Nov 2024
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Renpin ENT. Hospital, China, Nanjing Renpin ENT. Hospital, China, Chengdu Renpin ENT. Hospital, China
- Responsible party
- Principal investigator, Hongsheng Tan, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hongsheng Tan, Dr, Principal investigator, Shanghai Jiao Tong University School of Medicne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383675
- Sponsor's protocol ID
- TSM-2026
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHR-Based Risk Factors With Prediction Models for Tinnitus Subtypes: A Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07383675
- Acronym / sponsor ID
- TSM-2026
- Conditions
- Tinnitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,345 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Chongqing Renpin ENT. Hospital, China, Nanjing Renpin ENT. Hospital, China, Chengdu Renpin ENT. Hospital, China
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 3 Feb 2026 (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.
Tinnitus affects an estimated 10-15% of the global population and can substantially impair quality of life, yet clinically actionable approaches for subtype identification and risk stratification remain limited. This multicenter, cross-sectional observational study will use de-identified electronic health record (EHR) data from three otolaryngology specialty hospitals in China to address these gaps. All extracted data will be de-identified with direct identifiers removed, and privacy safeguards will be implemented in accordance with institutional policies and applicable regulations to protect patient confidentiality.
Detailed description
Using a prespecified, clinically informed framework, we will classify tinnitus into relevant subtypes, including somatosensory tinnitus, acute vs. chronic tinnitus, pulsatile tinnitus, and sudden hearing loss-related tinnitus. We will first describe the distribution of these subtypes and characterize their demographic, clinical, and laboratory profiles. We will then evaluate associations between candidate risk factors and subtype membership using multivariable analyses to quantify adjusted effects. Finally, we will develop and validate multivariable prediction models using both conventional statistical approaches and machine learning methods to support tinnitus subtype classification. Model performance will be assessed using discrimination, calibration, and clinical utility metrics. By integrating routine clinical data with biomarker information captured in real-world care, this study aims to provide evidence-based tools to improve tinnitus subtype diagnosis and enable more personalized clinical assessment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with any type of tinnitus from three otolaryngology specialty hospitals in China
Key inclusion criteria (3 listed)
- ≥18 years old；
- Patients diagnosed with various types of tinnitus；
- Patients with available electronic medical records, including demographic and clinical information.
Key exclusion criteria (3 listed)
- Patients with incomplete data；
- Patients with severe neurological；
- Patients with disorders that may confound tinnitus assessment.
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 |
|---|---|---|
| Observational groupThis is a multicenter, cross-sectional observational study using existing electronic health record data collected during routine clinical care.We will use retrospectively extracted electronic health record data from multiple otolaryngology specialty hospitals to identify risk factors and develop predictive models for tinnitus subtypes at a single index time point. | Other | – |
Primary outcome
Number of Patients in Each Tinnitus Subtype
Time frame: baseline
The number of participants classified into each predefined tinnitus subtype based on an integrated diagnosis clinical classification framework.
2 secondary outcomes
Adjusted odds ratios of risk factors associated with each tinnitus subtype
Time frame: baseline
Accuracy of prediction models for identifying tinnitus subtype classification
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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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. This study is not recruiting at the moment.
Hongsheng Tan, Dr principal investigator
Shanghai Jiao Tong University School of Medicne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Shanghai Jiao Tong University School of Medicine 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients in Each Tinnitus Subtype (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.