Effects of Continuous Positive Airway Pressure (CPAP) on Early Signs of Atherosclerosis in Patients With Obstructive Sleep Apnea: a Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Intima media thickness (IMT)
研究概览
简要总结
Obstructive sleep apnea (OSA) is associated with adverse cardiovascular outcomes, including acute myocardial infarction and stroke. Atherosclerosis is an important step for these events. Recent studies demonstrated the independent association between OSA and validated markers of atherosclerosis. However, the impact of treatment with continuous positive airway pressure (CPAP) on these markers is unknown.
The purpose of this study is to determine whether CPAP therapy can reverses early signs of atherosclerosis in apparently healthy OSA patients.
详细描述
Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete obstruction of the upper airway during sleep resulting in oxygen desaturation and arousals from sleep. OSA is recognized as an important public health problem, affecting 9 and 24 % of middle-aged females and males, respectively. There is now compelling evidence that severe OSA is associated with increased cardiovascular morbidity and mortality, mainly due to acute myocardial infarction and stroke. Moreover, the current standard treatment with application of continuous positive airway pressure (CPAP) during the night was associated with decreased non-fatal and fatal cardiovascular events.
There are several mechanisms associated with OSA that are potentially harmful to the cardiovascular system, including sympathetic activation, systemic inflammation, production of reactive oxygen species, and endothelial dysfunction. Together, all these factors could contribute to atherosclerosis progression, a key mechanism involved in the genesis of myocardial infarction and stroke. For instance, we recently described the presence of early signs of atherosclerosis in otherwise healthy OSA subjects as characterized by alterations in validated markers of atherosclerosis, including increased arterial stiffness, evaluated by pulse wave velocity (PWV), as well as intima-media thickness (IMT) and carotid diameter (CD). All theses vascular abnormalities correlated significantly with the severity of the OSA.
In this study, we will perform a randomized study to evaluate the impact of CPAP therapy on PWV, IMT and CD as well as in catecholamine and C reactive protein. We made the hypothesis that CPAP promotes beneficial effects on atherosclerosis, independent of the other factors, such as blood pressure and cholesterol levels. To this end, we only will study young OSA patients that were free of co-morbidities. Patients will be randomized to no treatment (Control) or CPAP for 4 months. Evalutations will be performed at baseline and after 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males with recent sleep study (<1 month) showing severe obstructive sleep apnea, defined as at least 30 events of apnea and hypopnea per hour of sleep.
排除标准
- •Age >60 years old, body mass index (BMI) >35 kg/m2, diabetes mellitus, hypertension, cerebrovascular, aortic, heart, and valvar heart diseases, renal failure, arrhythmias, smoking habit, and chronic use of medications, including statins.
结局指标
主要结局
Intima media thickness (IMT)
Carotid diameter (CD)
Arterial stiffness (evaluated by PWV)
次要结局
- C-reactive protein (CRP)
- 24h blood pressure monitoring
- plasma catecholamine