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RecruitingNCT06530069Updated Aug 9, 2024

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

An observational study in Otomycosis, sponsored by Zhongshan Hospital Xiamen University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by Zhongshan Hospital Xiamen University · Observational

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study 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.

02

Conditions studied

  • Otomycosis

Keywords

  • Otomycosis
  • predisposing factor
03

In context

Lead sponsor

Zhongshan Hospital Xiamen University is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with otitis media, tympanic membrane perforation, or post-radiotherapy.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherexposures

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

06

What researchers measure

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.

    Time frame: 1month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.

Data sharing details ↗ · www.medresman.org

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06530069
Lead sponsor
Zhongshan Hospital Xiamen University
Responsible party
Sponsor
First posted
Jul 31, 2024
Start date
Aug 1, 2024
Primary completion
Aug 7, 2024
Completion
Aug 15, 2024 (estimated)
Last update
Aug 9, 2024

Study contacts

Chunsheng Ye
Contact
578881502@qq.com
+8613400661815
Chunsheng Ye, MD
principal investigator · Zhongshan Hospital Xiamen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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