Status:
UNKNOWN
The Effects of Exosomes in Otitis Media With Effusion
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Conditions:
Otitis Media With Effusion
Adenoid Hypertrophy
Eligibility:
All Genders
4-10 years
Brief Summary
The particularity of adenoids, as a reservoir of bacterial pathogens and immune molecules, is known to be significantly involved in children with otitis media with effusion (OME). As an important carr...
Detailed Description
This study will explore the pathogenesis of OME by detecting the exosome in middle ear fluid, nasopharyngeal secretions and peripheral blood in order to identify areas of opportunity for future resear...
Eligibility Criteria
Inclusion
- OME-Adenoid (OA) group:
- Children aged between 4 and 10 years old.
- Diagnosis of chronic otitis media with effusion, and the course of disease is at least 3 months.
- There are varying degrees of hearing loss. PTA (The mean hearing threshold of 500Hz, 1000Hz and 2000Hz) ≥ 30dB.
- Nasopharyngeal lateral X-ray showing A/N \> 0.6 of adenoids.
- Control-Adenoid (CA) group:
- Children aged between 4 and 10 years old.
- Nasopharyngeal lateral X-ray showing A/N \> 0.6 of adenoids.
- Control-OME (CO) group:
- Children aged between 4 and 10 years old.
- Diagnosis of chronic otitis media with effusion, and the course of disease is at least 3 months.
- There are varying degrees of hearing loss. PTA (The mean hearing threshold of 500Hz, 1000Hz and 2000Hz) ≥ 30dB.
Exclusion
- Patients who have had one or more episodes of otitis media in the previous one year.
- Any immunologic diseases.
- Any intrinsic diseases of hearing system, anatomic or physiologic defect of the ear.
- Pharmacologic abnormality.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05402267
Start Date
September 1 2022
End Date
May 1 2024
Last Update
June 2 2022
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