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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT00238069
Eligibility Criteria:
Inclusion Criteria:
* Adult (\>18yrs at the time of recruitment)
* Body mass index (BMI) ≥ 30
* Symptoms suggestive of sleep apnea
* Epworth Sleepiness Score (ESS) within range
* Positive sleep study for sleep apnea
Exclusion Criteria:
* Tobacco use within the last 3 months.
* Presence of other significant comorbid heart or lung disease
* Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
* Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
* Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
* Presence of severe or uncontrolled sinusitis, such that CPAP therapy will be difficult or uncomfortable.
* History of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of CPAP therapy.
* Night shift workers, or other subjects with significantly altered sleep-wake cycles.
* Baseline post-bronchodilator FEV1 \< 70% predicted.
* Severe gastroesophageal reflux disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00238069
Study Brief:
Protocol Section:
NCT00238069