Mechanisms of Endothelial Cell Dysfunction in Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- ODI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
- •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
研究组 & 干预措施
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.
干预措施: Continuous Positive Airway Pressure (CPAP) (Device)
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.
结局指标
主要结局
ODI
时间窗: 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.
次要结局
未报告次要终点
研究者
Ana C. Krieger
Dr. Ana Krieger, MD. MPH
Weill Medical College of Cornell University