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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01276860
Eligibility Criteria:
Inclusion Criteria:
* Healthy pediatric patients ages 6-18 years old
* with symptoms of OSA (snoring, pauses in sleep breathing, restless sleep, frequent arousals, excellive daytime sleepiness, morning headaches)
* with physical exam findings consistent with adenotonsillar hypertrophy
* those identified as good candidates for adenotonsillectomy
* who are to undergo a polysomnogram as part of their preoperative work-up
Exclusion Criteria:
* History of attention deficit disorder, developmental delay, or mental retardation
* Children taking any neurotropic medications (including antiepileptics, antidepressives, and stimulants)
* Children previously treated for OSA (surgically or medically)
* Children with significant comorbidities including other sleep-related disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT01276860
Study Brief:
Protocol Section:
NCT01276860