Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 936
- 试验地点
- 44
- 主要终点
- Systolic blood pressure evolution by comparing baseline and 6 months measurements
研究概览
简要总结
Targeted population:
Sleep apnea patients at high cardiovascular risk newly treated by CPAP
Hypothesis:
Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.
Main goal:
To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.
详细描述
Study procedures:
The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, CPAP compliance, side effects and residual events.
Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.
An interim analysis will be performed when 300 patients will be included.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 78 years
- •Men and women
- •AHI > 30 / hour
- •Patient with high cardiovascular score (>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
- •Patient affiliated to the National health insurance
- •Willingness to use a telemonitoring system
排除标准
- •Central sleep apnea syndrome
- •Previous CPAP treatment with respiratory support for sleep respiratory trouble
- •Cardiac failure with left ventricular ejection fraction lesser than 40%
- •Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
- •Terminal disease
结局指标
主要结局
Systolic blood pressure evolution by comparing baseline and 6 months measurements
时间窗: day 0 and month 6
Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days)
次要结局
- Subjective Sleepiness(inclusion and month 6)
- Health status(inclusion and month 6)
- Objective CPAP compliance at 6 months(day 0 and month 6)
- Fatigue(inclusion and month 6)
- Quality of Life(inclusion and month 6)
- Diastolic blood pressure evolution by comparing baseline and 6 months(day 0 and month 6)
- Physical activity(inclusion and month 6)
- Cost analysis(month 6)
研究者
Jean Louis PEPIN
Professor, PhD, Hospital Grenoble France
Fédération Française de Pneumologie