SLEEP APNEA SYNDROME AND TRISOMY 21 : Exploration of the Predictive Factors in the Population With Trisomy 21
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects
研究概览
简要总结
The obstructive sleep apnea syndrome (OSAS) is frequently reported in subjects with trisomy 21. The consequences of this syndrome are expressed in various disorders such as cognitive and cardiovascular alterations. It is also reported a premature exhaustion with the achievement of various professional or recreational activities, as well as an increase in the frequency of daytime sleepiness. In trisomy 21, there are factors that are systematically associated with obstructive apnea. The identification of these factors would make it possible to diagnose OSAS earlier, under-diagnosed in the population with trisomy 21 even though these OSAS are associated with increased cardiovascular risks.
The aim of this study is to identify the predictive factors associated with sleep apnea in the trisomy population in order to propose early detection.
OSAS treatment in a young adult with Down syndrome could reduce physical fatigue apparition during various activities, reduce daytime sleepiness, and have a positive impact on physical fitness, and therefore more broadly on health.
详细描述
The predictive factors for OSA that will be studied are: physical activity level, dentofacial disharmonies, blood parameters, motor disabilities, heart rate variability parameters measured during sleep and during autonomic nervous stimulation by orthostatic test.
All these factors will be linked to the data obtained by:
- polysomnography
- by the joint use of seismocardiography
OSAS lead to many associated disorders, which identified early can be better supported to limit the deleterious effects of this OSAS:
(i) a sudden and repeated activation of the sympathetic nervous system triggered by sleep fragmentation (ii) intermittent hypoxia associated with OSAS may increase insulin resistance through the involvement of an inflammatory state and oxidative stress.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Subjects with Down syndrome, able to practice physical activity all participants have received information all have signed the consent form
排除标准
- •pregnant women
- •Pharmacological treatment altering autonomic nervous system (ANS)
- •Contra-indication to physical exercise, such as atlanto-axial instability
结局指标
主要结局
Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects
时间窗: 4 months
OSAS will be diagnosed with polysomnography and seismocardiography. AHI threshold will be 15 to diagnose an OSAS (score).
次要结局
- questionnaire of physical activity(15 days)
- Motor skills(15 days)
- dysautonomia role on OSAS in DS(1 day)
- Biological profile(1 day)
- anthropometric characteristics role on OSAS in DS(1 day)
- Metabolic syndrome(1 day)
- morphologic parameters(1 day)
- Investigation of autonomic nervous system(1 day)
- Oxygenation and dysautonomia(1 day)
- Investigation of dysautonomia during sleep(3 nignts)
- Quantification of physical activity(15 days)
- Sleep questionnaire(15 days)