Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep in
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean nocturnal oxygen saturation measured by pulse oximetry
研究概览
简要总结
The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung disease.
详细描述
Patients with moderate to severe chronic obstructive pulmonary disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypothesis that nocturnal breathing and sleep during nights spent at moderate altitude are improved by oxygen therapy via a nasal cannula compared to room air (sham oxygen). Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 nights each spent at moderate altitude (St. Moritz Salastrains, 2048 m) separated by a wash-out period of at least 2 weeks spent at low altitude (<800 m).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
Oxygen
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: Oxygen (Drug)
Oxygen
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: sham oxygen (room air) (Drug)
Sham oxygen
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: Oxygen (Drug)
Sham oxygen
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: sham oxygen (room air) (Drug)
结局指标
主要结局
Mean nocturnal oxygen saturation measured by pulse oximetry
时间窗: Approximately 8 hours (during the first night at 2048 m)
Difference in mean nocturnal oxygen saturation between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.
Apnea/hypopnea index measured by polysomnography
时间窗: Approximately 8 hours (during the first night at 2048 m)
Difference in apnea/hypopnea index between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.
次要结局
- Mean nocturnal oxygen saturation measured by pulse oximetry(Approximately 8 hours (during the second night at 2048 m))
- Psychomotor vigilance test reaction time(Approximately at 10 a.m. on the second day at 2048 m)
- Apnea/hypopnea index measured by polygraphy(Approximately 8 hours (during the second night at 2048 m))
- Severe hypoxemia(Approximately 72 hours (day 1 to 3 at 2048 m))
- Subjective sleep quality visual analog scale score(Approximately 8 hours (during the second night at 2048 m))