Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Drug-resistant Hypertension : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- mean systolic blood pressure
研究概览
简要总结
The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).
详细描述
Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes. Resistant hypertension is defined in order to identify patients who are at risk of having secondary causes of hypertension, and who may benefit from specific diagnostic and therapeutic applications. Despite the fact that OSA is listed as one of the causes of resistant HT , paucity of works has demonstrated the magnitude of problems of untreated OSA in subjects with resistant HT. There is so far two study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though both studies were flawed by not including the control group, no randomization and limited sample size. We aim at conducting a randomized controlled study to explore the beneficial effect of CPAP treatment in subjects with OSA and resistant hypertension.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 65
- •known hypertension on ≧ 3 anti-hypertensive drugs
- •Apnea-hypopnea index ≧15
- •able to give informed written consent
排除标准
- •moderate renal impairment (glomerular filtration rate <30 mL/min/m2 )
- •endocrine/renal/cardiac causes of secondary HT
- •congestive heart failure and clinically fluid overloaded
- •On drugs that elevates BP e.g. NSAID, steroid
- •Non-compliance to anti-hypertensive medications
- •Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months
- •Active inflammatory/infective conditions e.g. rheumatoid arthritis
- •Excessive sleepiness that can be risky e.g. occupational driver, machine operator
- •Modification/changes of anti-hypertensive regimen within 8 weeks
研究组 & 干预措施
continuous positive airway pressure
干预措施: continuous positive airway pressure (Device)
observation
结局指标
主要结局
mean systolic blood pressure
时间窗: 8 weeks
次要结局
- mean arterial blood pressure(8 weeks)
- mean diastolic blood pressure(8 weeks)
- high sensitivity C-reactive protein(8 weeks)
- cardiac injury marker(8 weeks)
- oxidative stress marker(8 weeks)