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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT03546751
Eligibility Criteria:
Inclusion Criteria:
* Otherwise healthy children and young adults with a diagnosis of obstructive sleep apnea based on polysomnography criteria of an obstructive apnea hypopnea index \> 10 events/hr.
* For children a BMI range up to 99.7% and for adults BMI up to 32 kg/m2 is used.
Exclusion Criteria:
* The presence of elevated blood pressure
* The presence of diabetes or pre-diabetes
* The presence of craniofacial anomalies
* The presence of neuromuscular disorders
* The presence of syndromic or defined genetic abnormalities
* Pregnancy
* History of smoking (any smoking within the prior 6 mos or \>5 pack years total)
* The presence of infectious disease (e.g. including hepatitis B, C, HIV etc.)
* The presence of collagen vascular disease (e.g. lupus, arthritis, scleroderma, polymyositis, mixed-connective tissue disease, vasculitis etc)
* The presence of hepatic disease (including hepatitis fatty liver or cirrhosis)
* The presence of renal disease (including azotemia or clinical proteinuria)
* The presence of cardiopulmonary disease (e.g. known asthma, cystic fibrosis, congenital heart disease)
* Individuals using medications which could affect sleep or breathing (including hypnotics)
* Individuals using chronic anti-inflammatory therapy
* Individuals with any subjects with acute or chronic illness.
* Individuals using anti-hypertensive therapies
* Children with a a BMI \> 99.7%
* Adults with a BMI \> 32 kg/m2
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
21 Years
Study:
NCT03546751
Study Brief:
Protocol Section:
NCT03546751