Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 107
- 试验地点
- 20
- 主要终点
- Home Arterial Blood Pressure
研究概览
简要总结
The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the telemedicine system will enhance compliance and thus reduce self-measured blood pressure.
详细描述
The obstructive sleep apnea syndrome (OSAS) corresponds to repeated epochs of complete or incomplete pharynx collapses occurring during sleep. The Continuous Positive Airway Pressure is the gold standard treatment for OSAS. It consists of air insufflation in upper airways with a pressure of about 5 to 15 cm of water with a facial or nasal mask. CPAP treatment reduces cardiovascular morbi-mortality.
OSAS is associated with cardiovascular mortality. A dose response effect exists between severity and arterial blood pressure. A recent meta-analysis has shown in unselected OSAS patients with or without hypertension, treated or non-treated for hypertension, CPAP reduces 24 h ambulatory blood pressure of approximately 2 mmHg. This decrease corresponds to a significant reduction in cardiovascular risk.
The aim of the present study is to include OSAS patients with a high cardiovascular risk and to measure the effect of CPAP on home measurements of arterial blood pressure. This controlled randomized trial will compare the effect CPAP on arterial blood pressure in a group with a telemedicine system versus a group with standard home care CPAP treatment.
An interim analysis will be carried out when 100 patients have been included in the study.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years old men and women
- •stable patient
- •BMI<40kg/m²
- •OSA patients diagnosed with polysomnography or polygraphy
- •SCORE>5% and/or cardiovascular disease pas history :
- •transient ischemic attack, stroke, cerebral haemorrhagy
- •myocardial infraction, angor, coronary revascularization, arteriopathy, aortic aneurism
排除标准
- •central sleep apnea syndrome
- •SCORE<5%
- •cardiac failure
- •past history of hypercapnic chronic respiratory failure
- •past history of severe or intercurrent pathology which can not allow the patient follow-up
- •Incapacitated patients in accordance with article L 1121-6 of the public health code
- •patients taking part in another clinical trial
结局指标
主要结局
Home Arterial Blood Pressure
时间窗: Home arterial Blood Pressure is assessed at week 16
the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group.
次要结局
- CPAP compliance(week 16)
- Sleepiness(week 16)
- Physical Activity(week 16)
- Quality of Life(week 1)
- Cardiovascular risk SCORE(Week 16)