Long Term Effects of Positive Airway Pressure Therapies on Vascular Function in Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Long term evolution in arterial stiffness by pulse wave velocity
研究概览
简要总结
Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a independent cardio-vascular risk factor.
Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study measurements of arterial stiffness, and are strong predictors of late cardiovascular events.
This study will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.
详细描述
Obstructive sleep apnea (OSA) syndrome is responsible of vascular damage. Intermittent hypoxia causes oxidative stress and low-grade inflammation. By the way of increased sympathetic outflow, it's resulting endothelial dysfunction, atherosclerosis and an increase of arterial stiffness.
Finally these mechanisms are responsible of cardiovascular comorbidities: hypertension, cardiac arrhythmias or Left ventricular dysfunction. This patients presented coronary diseases or Strokes.
OSA characterized by intermittent hypoxia, is associated with atherosclerosis and vascular inflammation. Polymorphonuclear leukocytes (PMNs) are implicated in vascular inflammation by producing oxidizing radicals and proteolytic enzymes during PMN-endothelium interactions.
Reactive oxygen species (ROS) production is increased in activated cells and after attachment, PMNs release additional ROS inducing endothelial cell injury.
Continuous positive airway pressure (CPAP) is the current "gold standard" treatment for OSA, Use of CPAP restored the respiratory flow, prevents nocturnal respiratory events and daytime symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with a initial visit there is 4-7 years for the VNI-SOH protocol (Réf CPP Sud-Est V: 38/2006/2)
- •Male or female patient, aged 20-75 years at the initial visit there is 4 to 7 years;
- •Patients with a BMI> 30kg / m2 at diagnostic;
- •Patient affiliated to a social security;
- •Having given its written consent to participate in the study.
排除标准
- •Person private of liberty by judicial or administrative decision, person under legal protection measure (pregnant or nursing, patient under guardianship) Article L1121-8
- •Exclusion period for further studies
- •Patient died or lost sight since the initial visit there 4-7 years
结局指标
主要结局
Long term evolution in arterial stiffness by pulse wave velocity
时间窗: 4 to 7 years from baseline assessment
次要结局
- Endothelial dysfunction by peripheral arterial tone(4 to 7 years from baseline assessment)
- Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling(4 to 7 years from baseline assessment)
- Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin(4 to 7 years from baseline assessment)