Effects of Obstructive Sleep Apnea on the Frequency of Vaso-occlusive Crises Events and Bio-physical Markers in Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- number of VOC crises required hospitalization in the previous two years
研究概览
简要总结
Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell population, studies focusing on the associations of the two diseases and their common pathophysiological mechanisms are scarce. OSA is one of the most common conditions responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients, could increase the risk for complications. Finally, OSA is accompanied by impaired vascular function and autonomic nervous system dysfunction in the general population. Indeed, the presence of OSA in SCD could increase the clinical severity of patients and the frequency of VOC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Homozygous HbS (Hemoglobin S) (SS) patients,
- •aged between 15 and 3 months and 50 years old,
- •in steady state (i.e. without vaso-occlusive crisis or recent blood transfusion),
- •followed by the sickle cell center of the Hospices Civils de Lyon,
- •and showing symptoms of OSA.
排除标准
- •Patients receiving treatment of OSA,
- •recent blood transfusion (less than 2 months),
- •patients not at steady state (VOC or acute chest syndrome less than 2 months),
- •pregnancy.
结局指标
主要结局
number of VOC crises required hospitalization in the previous two years
时间窗: day 1
Calculated over a 2 years period before inclusion. VOC requiring hospitalizations will be recorded. Measured at day 1
次要结局
- Markers of blood coagulation(Day 365)
- Vascular function (microvascular reactivity to skin heating test)(Day 365)
- Blood inflammatory markers(Day 365)
- Blood cell counts and markers of hemolysis(Day 365)
- Markers of nitric oxide metabolism(Day 365)
- Hemorheological parameters(Day 365)
- Frequency of VOC(Day 365)
- Oxidative stress markers(Day 365)
- Arterial blood gases(Day 365)
- autonomic nervous system activity (measured by heart rate variability analysis)(Day 365)