Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Percentage of patients with nocturnal desaturation and patients with OSA
研究概览
简要总结
Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC.
The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal 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
- Prevention
- 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
- •Night VOC Group:
- •night VOC ≥ 2 in the previous year
- •written informed consent
- •Daytime VOC Group:
- •VOC no nocturnal
- •diurnal VOC ≥ 2 in the previous year
- •written informed consent
- •Slightly symptomatic group:
- •no hospitalization for VOC
- •written informed consent
排除标准
- •Taking opioids
- •Taking medication that alters sleep (antidepressants, benzodiazepines ...)
- •Known history of sleep apnea syndrome
- •Known history of serious psychiatric disorder
- •Recent vaso-occlusive crisis (within 3 weeks)
- •Changes in background treatment (Hydrea or exchange transfusions) in the past 12 months
- •Inactive affiliation to social security
- •Under legal protection
- •A female who is pregnant or breastfeeding
- •Prisoners
- •Emergency situation
- •Refusing to participate in the study
研究组 & 干预措施
Nocturnal VOC
干预措施: Polysomnography and blood sample (Other)
Diurnal VOC
干预措施: Polysomnography and blood sample (Other)
Slightly symptomatic
干预措施: Polysomnography and blood sample (Other)
结局指标
主要结局
Percentage of patients with nocturnal desaturation and patients with OSA
时间窗: at 1 year
次要结局
- Apnea-Hypopnea Index(at 1 year)
- Minimum oxygen saturation level(at 1 year)
- Oxygen desaturation index(at 1 year)
- Quantitative analysis of biomarkers in plasma samples(at 1 year)
- Quantitative analysis of proinflammatory and anti-inflammatory cytokines(at 1 year)
- Minimum oxygen saturation level during rapid eye movement (REM) sleep in patients with recurrent priapism and in patients who never presented priapism(at 1 year)
- Sleep time with arterial oxygen saturation less than 90%(at 1 year)