Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Hypoxemia Hypoxia Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College - Weill Cornell Pulmonary Associates

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Study Group 1: Sleep Apnea

Inclusion criteria

21 years or older
Presence of intermittent hypoxemia (IH) and obstructive sleep apnea (OSA)
No diagnosis of hypertension, coronary artery disease, diabetes, stroke, or evidence of underlying vascular disease

Exclusion criteria

Smoking
Pregnancy
Known cardiovascular disease, stroke, or diabetes
Current or previous treatment for sleep apnea
Central or Cheyne-Stokes sleep apnea
Use of supplemental oxygen at night
Alcohol abuse
Regular use of sedatives
Regular use of aspirin or cholesterol lowering agents

Study Group 2: Normal Controls

Inclusion criteria

21 years or older
No diagnosis of intermittent hypoxemia (IH) or obstructive sleep apnea (OSA)
No diagnosis of hypertension, coronary artery disease, diabetes, stroke, or evidence of underlying vascular disease

Exclusion criteria

Smoking
Pregnancy
Known cardiovascular disease, stroke, or diabetes
Use of supplemental oxygen at night
Alcohol abuse
Regular use of sedatives
Regular use of aspirin or cholesterol lowering agents

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Mar 11, 2009
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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