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Sponsors and Collaborators: |
Weill Medical College of Cornell University National Institutes of Health (NIH) |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00859950 |
Sleep apnea is a common sleep disorder characterized by temporary stops in breathing during sleep and has been associated with the development of cardiovascular disease. This research will investigate one potential mechanism leading to the development of cardiovascular disorder, specifically, the blockage of blood vessels called "vascular occlusion", in subjects with sleep apnea. A group of healthy controls will be used for comparison.
All subjects will undergo clinical evaluation followed by an overnight sleep study and a morning blood draw. Subjects with sleep apnea will be treated according to standard clinical management and followed under the research protocol for one month. At the end of one month, a repeat blood draw will be performed on the sleep apnea subjects for comparative analysis. If a control subject is found to have any abnormality during this research study, he or she will be referred for further clinical evaluation.
Condition | Intervention |
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Obstructive Sleep Apnea Intermittent Hypoxemia |
Device: Continuous Positive Airway Pressure (CPAP) |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea |
Estimated Enrollment: | 60 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sleep Apnea: Active Comparator
Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.
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Device: Continuous Positive Airway Pressure (CPAP)
Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw.
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Normal Control: No Intervention
Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
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The importance of this project is to investigate mechanisms of vascular disease in sleep apnea and determine pathways for intervention, aiming to prevent the development of cardiovascular disease in these individuals.
This proposed research aims to evaluate both NTPDase activity in lymphocytes and levels of circulating endothelial cells (CECs) in patients with intermittent hypoxemia (IH) due to obstructive sleep apnea (OSA) and healthy controls. This is an original approach to define mechanisms which underlie the high incidence of occlusive vascular events in patients with OSA. The evaluation of such pathophysiological mechanisms will lead to a better understanding of the pathways involved and the development of therapeutic strategies targeting the reduction or avoidance of endothelial injury with the ultimate goal of reducing morbidity and mortality associated with these pathologic events in sleep apnea. The standard of care will be used in this protocol, which involves the use of CPAP (continuous positive airway pressure) for treating sleep apnea.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Study Group 1: Sleep Apnea
Inclusion Criteria:
Exclusion Criteria:
Study Group 2: Normal Controls
Inclusion Criteria:
Exclusion Criteria:
Contact: Claire Schlemme | 646-962-2672 | ces2009@med.cornell.edu |
United States, New York | |
Weill Cornell Medical College - Weill Cornell Pulmonary Associates | |
New York, New York, United States, 10021 |
Principal Investigator: | Ana C Krieger, MD, MPH | Weill Cornell Medical College |
Responsible Party: | Weill Cornell Medical College ( Ana C. Krieger, MD ) |
Study ID Numbers: | 0811010102 |
Study First Received: | March 10, 2009 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00859950 History of Changes |
Health Authority: | United States: Institutional Review Board |
Sleep Apnea Vascular Occlusion Nocturnal Polysomnography Continuous Positive Airway Pressure |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Nervous System Diseases Respiration Disorders |
Sleep Apnea, Obstructive Sleep Disorders Dyssomnias Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |