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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00371293
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe OSA (as defined by an apnea-hypopnea index \[AHI\] score greater than 15 events per hour)
* Body mass index greater than 30 kg/m
* Baseline CRP greater than 1.0 mg/dL
Exclusion Criteria:
* Predominant central sleep apnea
* Type 1 Diabetes
* Type 2 Diabetes associated with either: (a) unstable anti-diabetic therapy (anti-diabetic medication changes within past 3 months); (b) Hemoglobin A1C levels \> 7%; (c) Inability to perform home blood glucose monitoring (fingerstick checks).
* Requires use of supplemental oxygen
* Acute coronary syndrome or stroke in the 3 months prior to study entry
* A high-risk occupation or motor vehicle driving record, as defined by a score of 10 points or higher on an occupational and driving habits questionnaire
* Blood pressure greater than 160/95 mm Hg (may be re-screened after blood pressure control is obtained)
* Active infection, cancer, or chronic inflammatory disorder
* Use of systemic steroids
* Currently on an unstable dose of statin therapy (participants taking statins must be on a stable dose for at least 8 weeks prior to study entry)
* Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)
* Consumes more than 14 alcoholic drinks per week
* History of surgery in the 3 months prior to study entry
* Sustained ventricular or supraventricular tachycardia greater than 30 seconds during overnight sleep study
* Known left ventricular ejection fraction less than 30% or decompensated congestive heart failure requiring hospitalization in the year prior to study entry
* Any episode of decompensated respiratory function requiring hospitalization in the year prior to study entry
* Severe restless leg syndrome or chronic pain syndrome that gives rise to frequent awakenings at night, as determined during the overnight sleep study (individuals may still be enrolled if these sleep-disrupting disorders can be resolved prior to study entry)
* Pregnant or likely to become pregnant (i.e., pre-menopausal and not using a form of birth control)
* Severe depression, as defined by a score of 29 or higher on the Beck Depression Index, or suicidal ideation
* Serious medical or psychological condition that may compromise the participant's safety or successful participation in the study, in the opinion of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00371293
Study Brief:
Protocol Section:
NCT00371293