Down Syndrome, Physical Activity and Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- phenotyping of sleep in a population with Down's syndrome, its determinants, and the consequences of these disorders, with a specific focus on sleep apnea syndrome, whose origin is multisystemic
研究概览
简要总结
To realize a sleep phenotyping in a population with Down syndrome, its determinants, and the consequences of these disorders, with a specific focus on sleep apnea syndrome.
详细描述
Sleep disorders are widely observed in the Down's syndrome population, due to a number of risk factors, and can become established in early childhood. Diagnosis of sleep disorders in Down's syndrome is difficult and often delayed, which can contribute to poor health in children with Down's syndrome. Phenotyping sleep characteristics in this Down Syndrome population will enable early identification of the consequences of these disorders, with a specific focus on sleep apnea syndrome, whose origin is multisystemic.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total autosomal trisomy caused by the presence of a third copy (partial or total) of chromosome 21
排除标准
- •People with abnormal electrocardiographic tracings,
- •Existence of heart failure or cardiovascular disease, as determined by any abnormalities in cardiovascular adaptations to exercise.
- •Existence of a declared or uncontrolled progressive disease.
- •pregnant or breast-feeding women.
结局指标
主要结局
phenotyping of sleep in a population with Down's syndrome, its determinants, and the consequences of these disorders, with a specific focus on sleep apnea syndrome, whose origin is multisystemic
时间窗: Visite 2: 2 nights
Diagnosis of Sleep Apnea Syndrome using calculation of apnea hypopnea index (AHI)\>15 events/h
次要结局
- Sleep-disordered breathing associated with dysautonomia(Visite 2: up to 3 nights)
- Sleep-disordered breathing associated with a specific cranial structure(Day 0)
- Sleep-disordered breathing associated with inadequate physical activity(Visite 1: up to 1 hour)
- Sleep-disordered breathing associated with specific abnormalities of the biological work-up(Visite 1: the morning before the physical activity)
- Sleep-disordered breathing associated with specific neurobehavioral disorders(Day 0)