Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients With Sleep Apnea and Without Daytime Sleepiness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Incidence of hypertension
研究概览
简要总结
The objective of the study is to evaluate the effect of CPAP over the incidence of cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.
The hypothesis of the study is the following: The existence of sleep disordered breathing in the general population is associated to an increased incidence of arterial hypertension and to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular complications.
The end points of the study are new diagnosis of arterial hypertension and new cardiovascular events.
All patients, after randomization, will be followed for three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epworth <10
- •Apnea-Hypopnea Index ≥20
排除标准
- •Presence of any chronic disease
- •Presence of cardiovascular disease
- •Refusal to sign informed consent
- •Drug addiction and/or alcoholism
结局指标
主要结局
Incidence of hypertension
Incidence of cardiovascular events
次要结局
- Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity
- Relationship between cardiovascular events and SAHS severity