Exploring the Risk Factors of Otomycosis: A Case-Control Study

NCT06530069 | Recruiting

• 1 other identifier: xmzsyyky-2024-078
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore the risk factors of fungal otitis externa in the fungal otitis externa patients The main question it aims to answer is: What behaviors lead to the occurrence of fungal otitis externa? Participants will complete a detailed questionnaire survey. If there is a comparison group: Researchers will compare the healthy group and the disease group to see if there are any differences.

Conditions

Otomycosis

Keywords

Otomycosis; predisposing factor

Outcome Measures

Primary Outcomes (1)

• Odds Ratio

  The ratio of exposed to non-exposed individuals in the case group divided by the ratio of exposed to non-exposed individuals in the control group.

  1month

Study Arms (2)

Case Group

this group consists of patients who have been diagnosed with otomycosis.Observational exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.

Other: exposures

Control Group

This group includes healthy individuals who have not been diagnosed with otomycosis during medical examinations.Observational exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.

Other: exposures

Interventions

exposures OTHER

exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.

Case Group; Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Our institution is a tertiary first-class comprehensive hospital. Both the disease group and the control group are seen and screened at our facility

You may qualify if:

• Symptoms in the case group include tinnitus, ear fullness or blockage, itching, ear pain, discharge, and hearing loss. Physical examination reveals the presence of hyphae, scabs, secretions, masses, pus, red skin, erosion, swelling, or granulation in the ear canal. Laboratory fungal cultures must be positive. The control group does not have the aforementioned ear symptoms and has not sought medical attention for ear-related symptoms.

You may not qualify if:

• Patients with otitis media, tympanic membrane perforation, or post-radiotherapy.

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Zhongshan Hospital of Xiamen university

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Otomycosis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Chunsheng Ye, MD

  Zhongshan Hospital Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunsheng Ye

CONTACT

+8613400661815; 578881502@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion: August 7, 2024
• Study Completion: August 15, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available within six months after the completion of the study and will remain accessible for at least ten years.
• Access Criteria: The data will be open to peer-reviewed researchers. Researchers requesting access to the data must submit a research proposal and pass our review process. All data requestors must also adhere to a data use agreement.

Locations

CN (1)