Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Detailed description
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).
Interventions
OTHERAltitude exposure
Stay at different altitudes: 490, 1650, 2590 m
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* chronic obstructive pulmonary disease (COPD), GOLD grade 2-3 * residents at low altitude (\<800 m)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 2590 m | mean nocturnal oxygen saturation measured by pulse oximetry |
| Change in apnea/hypopnea index from baseline measured at 490 m | Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m | apnea/hypopnea index measured by polysomnography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | apnea/hypopnea measured by polysomnography |
| 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 | apnea/hypopnea index measured by polysomnography |
| Change in subjective sleep quality from baseline measured at 490 m | Change in subjective sleep quality from 490 m during 2 days at 2590 m | Visual analog scale of sleep quality |
| Change in reaction time from baseline measured at 490 m | Change in reaction time from 490 m baseline during 2 days at 2590 m | psychomotor vigilance test reaction time |
Countries
Switzerland
Outcome results
None listed