Study to Investigate Sleep Apnea Patients at Altitude
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Prevalence and severity of sleep disordered breathing
研究概览
简要总结
The purpose of the study is to investigate the effect of an altitude sojourn on patients with the obstructive sleep apnea syndrome
详细描述
Previous observations do not allow to draw firm conclusions on the effect of altitude sojourn on sleep, breathing and daytime performance in patients with the obstructive sleep apnea syndrome. Furthermore, the susceptibility of sleep apnea patients to high altitude related illness is not known. Therefore, the purpose is to study untreated patients with obstructive sleep apnea syndrome living at low altitude during a sojourn of a few days at moderate altitude in order to evaluate the physiologic effects of hypobaric hypoxia in these patients. We hypothesize that: 1. Sleep and nocturnal breathing disturbances in untreated OSA patients are more pronounced at moderate altitude compared to low altitude. 2. The increase in sleep related breathing disturbances at moderate altitude is due to an increase in central apnea/hypopnea
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstructive sleep apnea syndrome based on symptoms and a sleep study
排除标准
- •Sleep disorders other than obstructive sleep apnea syndrome
- •Other than mild, stable cardiovascular disease
- •Other than mild lung disease
- •Chronic rhinitis, previous uvulopalatopharyngoplasty
- •Treatment with drugs that affect respiratory center drive
- •Internal, neurologic or psychiatric disease that interferes with sleep quality
- •Previous intolerance to moderate or low altitude < 2600m
结局指标
主要结局
Prevalence and severity of sleep disordered breathing
时间窗: during altitude sojourn
次要结局
- alterations in sleep structure and vigilance; high altitude related illness(during altitude sojourn)