Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in mean nocturnal oxygen saturation from baseline measured at 490 m
研究概览
简要总结
The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude.
详细描述
This randomized cross-over trial evaluates the hypothesis that patients with chronic obstructive pulmonary disease experience nocturnal hypoxemia, periodic breathing and sleep disturbances when staying at moderate altitude. Sleep studies and clinical evaluations will be performed during 2 days in Zurich (490 m, low altitude baseline) and during 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- •residents at low altitude (<800 m)
排除标准
- •Unstable condition, COPD exacerbation
- •Mild (GOLD 1) or very severe COPD (GOLD 4)
- •requirement for oxygen therapy at low altitude residence
- •hypoventilation
- •pulmonary hypertension
- •more than mild or unstable cardiovascular disease
- •use of drugs that affect respiratory center drive
- •internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.
- •previous intolerance to moderate altitude (<2600m).
- •Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study.
- •Pregnant or nursing patients
研究组 & 干预措施
A: low-intermediate-high altitude
Altitude exposure sequence A, 490-1650-2590m
干预措施: Altitude exposure (Other)
B: low-high-intermediate altitude
Altitude exposure sequence B, 490-2590-1650m
干预措施: Altitude exposure (Other)
C: intermediate-high-low altitude
Altitude exposure sequence C, 1650-2590-490m
干预措施: Altitude exposure (Other)
D: high-intermediate-low altitude
Altitude exposure sequence D, 2590-1650-490m
干预措施: Altitude exposure (Other)
结局指标
主要结局
Change in mean nocturnal oxygen saturation from baseline measured at 490 m
时间窗: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 2590 m
mean nocturnal oxygen saturation measured by pulse oximetry
Change in apnea/hypopnea index from baseline measured at 490 m
时间窗: Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m
apnea/hypopnea index measured by polysomnography
次要结局
- Change in mean nocturnal oxygen saturation from baseline measured at 490 m(Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 1650 m)
- Change in apnea/hypopnea index from baseline measured at 490 m(Change in apnea/hypopnea index from 490 m baseline during stay at 1650 m)
- Change in subjective sleep quality from baseline measured at 490 m(Change in subjective sleep quality from 490 m baseline during 2 days at 1650 m)
- Change in reaction time from baseline measured at 490 m(Change in reaction time from 490 m baseline during 2 days at 1650 m)