A Multicenter Cross-sectional Study on Tinnitus Subtypes and Risk Factors

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.

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Other: Observational group

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 Type: Observational
• Enrollment (Actual): 3345

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Chongqing Renpin ENT Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with any type of tinnitus from three otolaryngology specialty hospitals in China

Description

Inclusion Criteria:

• ≥18 years old；
• Patients diagnosed with various types of tinnitus；
• Patients with available electronic medical records, including demographic and clinical information.

Exclusion Criteria:

• Patients with incomplete data；
• Patients with severe neurological；
• Patients with disorders that may confound tinnitus assessment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	baseline

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Chongqing Renpin ENT. Hospital, China; Nanjing Renpin ENT. Hospital, China; Chengdu Renpin ENT. Hospital, China
• Investigators: Principal Investigator: Hongsheng Tan, Dr, Shanghai Jiao Tong University School of Medicne

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): January 16, 2026

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tinnitus
• Other Study ID Numbers: TSM-2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No