Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in Epworth Sleepiness Scale From Baseline to End of Study
研究概览
简要总结
Many individuals with Down syndrome (DS) have breathing problems during sleep. This is called obstructive sleep apnea syndrome (OSAS). OSAS is very common in individuals with Down syndrome because of the shape of their face and tongue and because of their low muscle tone. OSAS can cause a lot of health problems including behavioral and learning problems as well as heart problems.
The purpose of this research study is to look at the effects of treating OSAS in individuals with Down syndrome with a machine called Continuous Positive Airway Pressure (CPAP). The investigators want to see if treatment of OSAS improves learning, behavior and heart problems.
详细描述
All individuals participating in the study will be evaluated for obstructive sleep apnea syndrome (OSAS) with a baseline sleep study. Based on the results of the sleep study,individuals with OSAS will be randomly assigned into two groups. One group will receive continuous positive airway pressure (CPAP) and the other intervention group will receive sham CPAP(placebo) for four months. CPAP is a machine with a mask that fits over the nose, is worn during sleep and helps keep the airway open. Sham CPAP (placebo) is a machine that looks and sounds like a CPAP machine but does not give pressure so it does not treat OSAS. Individuals with normal breathing during the sleep study will not receive a machine, and will serve as controls.
Individuals will also have baseline tests including blood tests, an echocardiogram (pictures of the heart), a walking test and learning tests. After 4 months, the baseline tests will be repeated in all participants. At the end of the study, all individuals with OSAS will get treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8-20 years
- •Down syndrome (based on the characteristic phenotype)
- •Families provide informed consent and child provides assent
排除标准
- •Subjects and families who do not speak English well enough to undergo psychometric testing.
- •Subjects living in institutions where there is no primary caregiver to participate in the neurocognitive/behavioral battery.
- •Major chronic lung disease such as chronic aspiration.
- •Previous or current CPAP therapy.
- •Participation in a weight loss program.
- •Craniofacial or neuromuscular conditions other than those associated with DS.
- •Untreated hypothyroidism. Participants with normal thyroid function tests will be included in the study.
结局指标
主要结局
Change in Epworth Sleepiness Scale From Baseline to End of Study
时间窗: 4 Months
The primary aim of the study is to assess the relationship between obstructive sleep apnea syndrome (OSAS) and the neurocognitive and behavioral outcomes of individuals with Down syndrome. Sleepiness was assessed using the pediatric version of the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person's general level of daytime sleepiness, or average sleep propensity in daily life. The ESS asks people to rate, on a 4-point scale (0, low to 3, high) their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives. The total ESS score provides an estimate of a general characteristic of each person's average level of sleepiness in daily life (0= no chance of dozing/no daytime sleepiness to 24=high chance of dozing/lots of daytime sleepiness).
次要结局
- Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months(4 Months)
- Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months(4 Months)
- Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months(4 Months)