Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Apnea/hypopnea index measured by polysomnography
研究概览
简要总结
The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with pulmonary hypertension or with interstitial lung disease.
详细描述
Patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), breathing and sleep during a 2 day sojourn at moderate altitude are impaired in comparison to low altitude; b), breathing and sleep during a 2 day sojourn at moderate altitude are improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 days 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). The order of stays at the different altitudes and of the treatments will be randomized.
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
- •Precapillary pulmonary hypertension, or interstitial lung disease.
- •New York Heart Association class 2-
- •Residence at low altitude (<800m).
排除标准
- •Unstable or exacerbated condition
- •Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4
- •requirement for oxygen therapy at low altitude residence
- •hypoventilation
- •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
Low altitude sojourn
Sojourn at low altitude (490 m, baseline)
干预措施: Sham oxygen (room air) (Drug)
Moderate altitude sojourn
Sojourn at moderate altitude (2048 m)
干预措施: Moderate altitude sojourn (Behavioral)
Moderate altitude sojourn
Sojourn at moderate altitude (2048 m)
干预措施: Low altitude sojourn (Behavioral)
Moderate altitude sojourn
Sojourn at moderate altitude (2048 m)
干预措施: Oxygen (Drug)
Moderate altitude sojourn
Sojourn at moderate altitude (2048 m)
干预措施: Sham oxygen (room air) (Drug)
Low altitude sojourn
Sojourn at low altitude (490 m, baseline)
干预措施: Moderate altitude sojourn (Behavioral)
Low altitude sojourn
Sojourn at low altitude (490 m, baseline)
干预措施: Low altitude sojourn (Behavioral)
Low altitude sojourn
Sojourn at low altitude (490 m, baseline)
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: Moderate altitude sojourn (Behavioral)
Oxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: Low altitude sojourn (Behavioral)
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 (room air)
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
干预措施: Moderate altitude sojourn (Behavioral)
Sham oxygen (room air)
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
干预措施: Low altitude sojourn (Behavioral)
Sham oxygen (room air)
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
干预措施: Oxygen (Drug)
Sham oxygen (room air)
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
干预措施: Sham oxygen (room air) (Drug)
结局指标
主要结局
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.
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.
次要结局
- 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))
- Apnea/hypopnea index measured by polygraphy(Approximately 8 hours (during the second night at 2048 m))
- Mean nocturnal oxygen saturation measured by pulse oximetry(Approximately 8 hours (during the second night at 2048 m))
- Sleep quality visual analog scale score(Approximately 8 hours (during the first night at 2048 m))
- Psychomotor vigilance test reaction time(Approximately at 10 a.m. on the second day at 2048 m)