Systematic Evaluation of Sleep Respiratory Disorders During Sleep in Children With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Vaso-occlusive and cerebral complications frequency
研究概览
简要总结
In Sickle cell disease children, sleep respiratory abnormalities are risk factors for vaso-occlusive complications, as well as cerebral vasculopathy.
A 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems frequency and etiology, as well as their influence on sickle cell disease complications.
详细描述
- Inclusion visit with physical examination. A 2.9 ml blood sample will be necessary, if not done within the framework of care within 6 months for: CBC (Cell Blood Count), reticulocytes counts (1.2 ml of blood), liver enzymes, electrolytes, urea, creatininemia (1,2 ml of blood) and fetal hemoglobin (0.5 ml of blood). - A complete standardized examination including nasopharynx endoscopy, if not yet done in usual care, to identified upper airway obstruction
- A standardized pneumology evaluation to identified obstructive lung symptomatology
- An ambulatory polysomnography will be performed within days following inclusion, during sleep and will allow electroencephalogram recording, oculomotricity, muscles (mentalis muscles and tibialis anterior) movements, electrocardiogram and respiratory activity recording.
The steering committee will classify the children in three populations based on their exam results:
- Group 1: no abnormality in polysomnography
- Group 2: obstructive sleep-related disorder
- Group 3: isolated sleep hypoxemia for group3, patients will have a new ambulatory polysomnography.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sickle cell disease children with either sickle cell anemia, compound heterozygozity SB0-thalassemia, or SDPunjab,
- •no prior transfusion program within 3 months,
- •no prior treatment with hydroxycarbamide within 3 months,
- •Aged 2 to 6 years,
- •Parents or tutors signed informed consent,
- •Prior physical examination,
- •Social security insurance.
- •Exclusion criteria:
- •Encephalopathy
- •Other disease that could interfere with protocol exams realization
- •Nitrous oxide analgesia contre-indication
- •Conventional hospitalization in the past 3 weeks
排除标准
- 未提供
结局指标
主要结局
Vaso-occlusive and cerebral complications frequency
时间窗: 18 months
Vaso-occlusive complications frequency and abnormal transcranial doppler (TCD) during the 18 months of follow up (cohort study) 3 subpopulations will be identified upon polysomnographic results: * Group 1: normal polysomnography * Group 2: sleep abnormalities related to obstructive upper airway disease or bronchial disease * Group 3: sleep abnormalities associated with non-obstructive pattern and isolated hypoxemia identified. The therapeutic trial will be done on this group.
次要结局
- Relationship between sleep abnormalities and transcranial doppler abnormalities(2 months)
- Polysomnography relevance compared to sleep ventilatory polygraphy(2 months)
- Respiratory sleep abnormalities frequency(18 months)