Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 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
Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep related breathing disturbances in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.
详细描述
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 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 1-2
- •Living at low altitude (<800m)
排除标准
- •COPD exacerbation
- •severe COPD, GOLD grade 3 or 4
- •arterial oxygen saturation <92% at low altitude (<800 m)
- •Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea.
- •Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day).
- •pregnant or nursing patients
研究组 & 干预措施
Dexamethasone
Dexamethasone 4 mg capsules, twice per day, orally
干预措施: Dexamethasone (Drug)
Placebo
Placebo capsules twice per day, orally
干预措施: Placebo (Drug)
结局指标
主要结局
Mean nocturnal oxygen saturation measured by pulse oximetry
时间窗: night 1 at 3200 m
Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group
次要结局
- Oxygen desaturation index(night 1 at 700 m)
- Mean nocturnal oxygen saturation measured by pulse oximetry(night 1 at 700 m)
- Apnea/hypopnea index(night 1 at 700 m)
- Psychomotor vigilance test reaction time(day 2 at 700 m)
- Subjective sleepiness(day 2 at 3200 m)