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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT01695967
Eligibility Criteria:
Inclusion Criteria:
* ages 3-16
* obstructive sleep apnea warranting adenotonsillectomy
* history of daytime nasal obstruction and or mouth breathing
* failed medical treatment with either oral anti-histamine or nasal steroid spray.
* turbinate hypertrophy on Physical Exam defined by \>50% obstruction
Exclusion Criteria:
* \<3 or \>16
* unwillingness to comply with study procedures
* congenital head and neck malformations, genetic syndromes, craniofacial anomalies
* no evidence of turbinate hypertrophy or symptoms of nasal obstruction
* pregnancy or breastfeeding
* bleeding disorders
* current therapy with coumadin or Pradaxa
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
16 Years
Study:
NCT01695967
Study Brief:
Protocol Section:
NCT01695967