Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Breathing and Sleep
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: sham oxygen (room air)
- Registration Number
- NCT02150590
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- residents at low altitude (<800 m)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oxygen sham oxygen (room air) oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Sham oxygen sham oxygen (room air) Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Oxygen Oxygen oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Sham oxygen Oxygen Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
- Primary Outcome Measures
Name Time Method Mean nocturnal oxygen saturation measured by pulse oximetry 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 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.
- Secondary Outcome Measures
Name Time Method Mean nocturnal oxygen saturation measured by pulse oximetry Approximately 8 hours (during the second 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.
Psychomotor vigilance test reaction time Approximately at 10 a.m. on the second day at 2048 m Difference in subjective sleep quality between visual analog scale 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 polygraphy Approximately 8 hours (during the second 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.
Severe hypoxemia Approximately 72 hours (day 1 to 3 at 2048 m) Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.
Subjective sleep quality visual analog scale score Approximately 8 hours (during the second night at 2048 m) Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.
Trial Locations
- Locations (1)
University Hospital Zurich, Pulmonary Division
🇨ðŸ‡Zurich, Switzerland