Status:
COMPLETED
The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Apnea Syndromes
Inflammation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation and heart condit...
Detailed Description
OSA is a common sleep disorder that is characterized by a brief collapse of the upper airway during sleep. This blockage prevents air from flowing properly into the lungs and causes pauses in breathin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00371293
Start Date
September 1 2006
End Date
December 1 2013
Last Update
April 5 2017
Active Locations (2)
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1
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, United States, 19014
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19014