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The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), October 2006
First Received: September 1, 2006   Last Updated: October 4, 2006   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00371293
  Purpose

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 conditions, but it is unknown whether this risk is related to the effects of OSA or obesity. This study will evaluate whether OSA or obesity plays the primary role in inflammation related to heart disease. The study will also determine the independent effects of OSA and obesity on insulin resistance and blood vessel function.


Condition Intervention
Sleep Apnea Syndromes
Inflammation
Behavioral: Weight Loss Program
Device: CPAP

MedlinePlus related topics: Heart Diseases Obesity Sleep Apnea
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Inflammatory Response to Sleep Apnea in Obese Subjects: The Cardiovascular Effects of Obstructive Sleep Apnea (COSA) Study

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Inflammation (measured at Week 24)

Secondary Outcome Measures:
  • Insulin resistance
  • HDL cholesterol levels
  • Triglyceride levels
  • LDL cholesterol levels (all measured at Week 24)

Estimated Enrollment: 195
Study Start Date: September 2006
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 breathing. If left untreated, OSA can cause high blood pressure, memory problems, weight gain, impotency, and headaches. It is also associated with an increased risk of inflammation-related heart conditions. Obesity is common among individuals with OSA and it may also be associated with inflammation. It is not known, however, whether the increased risk of heart problems is caused primarily by the inflammatory effects of OSA or obesity.

The most common treatment for OSA is continuous positive airway pressure (CPAP) therapy, in which a mask is worn over the nose during sleep. Air flows through the mask to maintain a level of pressure that keeps the throat open. The most common treatment for obesity is weight loss. This study will determine the primary cause of heart-related inflammation by evaluating the individual and combined effects of CPAP therapy and a weight loss program in treating obese individuals with OSA. The study will also determine the independent effects of these therapies on insulin resistance and blood vessel function.

This study will enroll obese individuals with moderate to severe OSA for a total of 24 weeks. Potential participants will first take part in an overnight sleep study at the University of Pennsylvania sleep lab. Sensors will monitor body functions during the night, including brain and muscle activity, eye movement, heart rate, breathing effort, air flow, and blood oxygen levels. Eligible participants will then be randomly assigned to CPAP therapy, a weight loss program, or a combination of the two. Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity. Participants receiving CPAP therapy will use a CPAP machine each night while they sleep. Study visits for all participants will occur at baseline and Weeks 6, 12, and 24. Blood will be collected to measure levels of triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and levels of C-reactive protein (CRP), which is an inflammation biomarker.

Insulin resistance will be evaluated using a glucose tolerance test, and blood vessel function will be evaluated using a brachial artery reactivity test in which artery size and blood flow will be measured with an ultrasound.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, as defined by a fasting glucose result greater than 125 mg/dL or use of hypoglycemic drugs
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371293

Contacts
Contact: Frederick F. Samaha, MD 215-823-6324 Rick.samaha@va.gov
Contact: Jessica C. Giesler, MA 215-823-7809 jcartier4@gmail.com

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19014
Principal Investigator: Frederick F. Samaha, MD            
Philadelphia Veterans Affairs Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19014
Sponsors and Collaborators
Investigators
Principal Investigator: Frederick F. Samaha, MD University of Pennsylvania, Philadelphia Veterans Affairs Medical Center
  More Information

No publications provided

Study ID Numbers: 442, R01 HL080076-01A1
Study First Received: September 1, 2006
Last Updated: October 4, 2006
ClinicalTrials.gov Identifier: NCT00371293     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Sleep Apnea
C-Reactive Protein
Obesity
Insulin Resistance

Study placed in the following topic categories:
Obesity
Sleep Apnea Syndromes
Heart Diseases
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Dyssomnias
Sleep Disorders
Insulin
Inflammation
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Insulin Resistance

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Disease
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Dyssomnias
Sleep Disorders
Inflammation
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on May 07, 2009