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:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT06100159
Eligibility Criteria:
Inclusion Criteria:
* Age 1-4 years with chronic otitis media with effusion and subjective hearing loss
* 1\. time ventilation tube insertion
* At least three months with middle ear fluid in both ears before inclusion
* ASA group 1 and 2
Exclusion Criteria:
* Recurrent AOM
* Concomitant adenoidectomy or adenotonsillectomy
* Lip-gum-cleft anomalies or other craniofacial malformations
* Downs syndrome
* Existing sleep apnea
* Asthmatic bronchitis or other chronic lung diseases like CF or other sleep disorders
* ASA \> 2
* Children with hyperkinetic syndrome
* Present breastfeeding during night
* Not fluent in Danish language
* Other systemic diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
4 Years
Study:
NCT06100159
Study Brief:
Protocol Section:
NCT06100159