Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT00859950|
Recruitment Status : Completed
First Posted : March 11, 2009
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Hypoxemia||Device: Continuous Positive Airway Pressure (CPAP)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: Sleep Apnea
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.
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.
No Intervention: Normal Control
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.
- ODI [ Time Frame: Day 1 (all subjects) ]The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859950
|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 Medical College of Cornell University|