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NCT Number: NCT07383675

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

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chongqing Renpin ENT Hospital

Chongqing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational Group

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adjusted odds ratios of risk factors associated with each tinnitus subtype

    Time frame: baseline

    Multivariable logistic regression-derived odds ratios quantifying the independent association between risk factors and specific tinnitus subtypes.

  2. Accuracy of prediction models for identifying tinnitus subtype classification

    Time frame: baseline

    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).

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Chengdu Renpin ENT. Hospital, China
  • Chongqing Renpin ENT. Hospital, China
  • Nanjing Renpin ENT. Hospital, China

Registry information

Official study title

EHR-Based Risk Factors With Prediction Models for Tinnitus Subtypes: A Multicenter Cross-sectional Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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