"Reversibility of Cardiovascular Injury With Continuous Positive Airway Pressure (CPAP) Use: Mechanisms Involved"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy
研究概览
简要总结
The purpose of this study is to determine the factors that are associated with improved cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to severe obstructive sleep apnea.
详细描述
We will monitor non-invasively changes in arterial stiffness, cardiac mass, pulmonary pressures, endothelial function, etc. We will also assess the reversibility of these changes after only 5-7 days of not using the CPAP mask. In a subgroup of subjects we will explore changes in coronary flow response after 12 weeks of CPAP use compared with baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects naïve of CPAP therapy just recently diagnosed with moderate to severe obstructive sleep apnea (OSA). The degree of OSA is defined by results of a comprehensive polysomnogram requiring an apnea hypopnea index (AHI) >15 events/hour and Epworth score >10, or an AHI >20 events/hour
- •either sex
- •between 21-50 years old.
排除标准
- •Systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg
- •Changes in antihypertensive medications in the last 6 weeks
- •Restless leg syndrome
- •Average overnight oxygen saturation below 80%
- •Current use of beta-blockers
- •History of coronary artery disease
- •History of Stroke
- •Atrial fibrillation
- •Peripheral vascular disease
- •Suspected cardiac valve abnormality
- •Ejection fraction <50%
- •Type I and type II Diabetes Mellitus (DM)
- •Asthma or confirmed Chronic Obstructive Pulmonary Disease
- •Cigarette smoking in the last 6 months
- •Raynaud's disease
- •Pregnancy (the normal hormonal changes that occur in pregnancy affect greatly arterial stiffness parameters) If a subject becomes pregnant we will discontinue data collection.
- •Physically incapable of resting on left lateral decubitus for 40 minutes.
- •Mastectomy with lymph node removal that might preclude us to monitor blood pressures on both arms
结局指标
主要结局
Changes in endothelium mediated response to brachial artery reactivity test between baseline and 4 and 12 weeks after CPAP therapy
时间窗: 14 weeks
Ultrasound based brachial artery reactivity tests will be performed at entry before CPAP therapy and at 4, 12 weeks post CPAP use and 5-7 days after CPAP withdrawal
次要结局
- Changes in coronary artery flow under a cold pressor test(13 weeks)
- Changes in arterial stiffness between baseline and after CPAP treatment(14 weeks)