Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT05402267
Eligibility Criteria:
Inclusion Criteria:
OME-Adenoid (OA) group:
1. Children aged between 4 and 10 years old.
2. Diagnosis of chronic otitis media with effusion, and the course of disease is at least 3 months.
3. There are varying degrees of hearing loss. PTA (The mean hearing threshold of 500Hz, 1000Hz and 2000Hz) ≥ 30dB.
4. Nasopharyngeal lateral X-ray showing A/N \> 0.6 of adenoids.
Control-Adenoid (CA) group:
1. Children aged between 4 and 10 years old.
2. Nasopharyngeal lateral X-ray showing A/N \> 0.6 of adenoids.
Control-OME (CO) group:
1. Children aged between 4 and 10 years old.
2. Diagnosis of chronic otitis media with effusion, and the course of disease is at least 3 months.
3. There are varying degrees of hearing loss. PTA (The mean hearing threshold of 500Hz, 1000Hz and 2000Hz) ≥ 30dB.
Exclusion Criteria:
1. Patients who have had one or more episodes of otitis media in the previous one year.
2. Any immunologic diseases.
3. Any intrinsic diseases of hearing system, anatomic or physiologic defect of the ear.
4. Pharmacologic abnormality.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
10 Years
Study:
NCT05402267
Study Brief:
Protocol Section:
NCT05402267