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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01403194
Eligibility Criteria:
Inclusion Criteria:
1. Body mass index greater than 95th percentile for age and gender
2. Moderate to severe obstructive sleep apnea (OSA) (as defined by an apnea-hypopnea index (AHI) score of ≥5 events per hour).
Only patients who provide informed assent or consent and also have consent from a parent will be included.
Exclusion Criteria:
1. Predominant central sleep apnea
2. Type 1 Diabetes
3. Type 2 Diabetes
4. Requires use of supplemental oxygen
5. Active infection, cancer, or chronic inflammatory disorder
6. Use of systemic steroids
7. Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT01403194
Study Brief:
Protocol Section:
NCT01403194