Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.
试验速览
- 阶段
- 4 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- change in mean arterial blood pressure
研究概览
简要总结
The aim of this study is to examine how effective CPAP treatment and treatment with nebivolol are respectively on reducing blood pressure and on endothelial dysfunction in patients suffering from obstructive sleep apnea and hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male/female ≥ 18 years old
- •patient with obstructive sleep apnea (apnea-hypopnea index ≥ 20) naïve for CPAP treatment
- •patient with weak or moderate hypertension (140 <= systolic blood pressure (SBP) < 180 mmHg and 90 <= diastolic blood pressure (DBP) < 110 mmHg naïve for any antihypertensive treatment
- •negative pregnancy test
- •ambulatory patient
- •patient who have signed the informed consent form
- •patient affiliated to social security
排除标准
- •pregnant or nursing woman
- •acute hepatic failure, biliary cirrhosis, cholestasis
- •clearance of Cockcroft < 30 ml/min/1.73m2
- •sick sinus syndrome, including sino-atrial block
- •second and third degree heart block (without a pacemaker)
- •history of bronchospasm and bronchial asthma
- •bradycardia (heart rate< 60bpm prior to start therapy)
- •severe peripheral circulatory disturbances
- •acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg)
- •severe daytime sleepiness (Epworth rating scale > 15)
- •known cardiovascular pathologies
- •contraindication to CPAP
- •allergy to nebivolol
- •patient treated with antihypertensive drug(s), with class I antiarrhythmics (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone)
- •patient treated with CPAP
- •patient kept in detention, major protected by the law, hospitalised person
- •patient currently participating in another clinical trial
研究组 & 干预措施
Nebivolol then CPAP
8 weeks of Nebivolol treatment (5m/day), 6 weeks of washout, 8 weeks of CPAP and if the patient is still hypertensive 8 weeks of Nebivolol plus CPAP treatment
干预措施: Nebivolol (Drug)
Nebivolol then CPAP
8 weeks of Nebivolol treatment (5m/day), 6 weeks of washout, 8 weeks of CPAP and if the patient is still hypertensive 8 weeks of Nebivolol plus CPAP treatment
干预措施: Continuous positive airway pressure (CPAP) (Device)
CPAP then Nebivolol
8 weeks of CPAP treatment, 6 weeks of washout, 8 weeks of Nebivolol and if the patient is still hypertensive 8 weeks of Nebivolol plus CPAP treatment
干预措施: Nebivolol (Drug)
CPAP then Nebivolol
8 weeks of CPAP treatment, 6 weeks of washout, 8 weeks of Nebivolol and if the patient is still hypertensive 8 weeks of Nebivolol plus CPAP treatment
干预措施: Continuous positive airway pressure (CPAP) (Device)
结局指标
主要结局
change in mean arterial blood pressure
时间窗: measurement assessed at w8,w14,w22
次要结局
- change in endothelial function(measurement assessed at w8,w14,w22)