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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Nocturnal nasal oxygen during stay at 2048 m
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland
Mean nocturnal oxygen saturation measured by pulse oximetry
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.
Time frame: Approximately 8 hours (during the first night at 2048 m)
Apnea/hypopnea index measured by polysomnography
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.
Time frame: Approximately 8 hours (during the first night at 2048 m)
Mean nocturnal oxygen saturation measured by pulse oximetry
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.
Time frame: Approximately 8 hours (during the second night at 2048 m)
Apnea/hypopnea index measured by polygraphy
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.
Time frame: Approximately 8 hours (during the second night at 2048 m)
Subjective sleep quality visual analog scale score
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.
Time frame: Approximately 8 hours (during the first night at 2048 m)
Psychomotor vigilance test reaction time
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.
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Time frame: Approximately at 10 a.m. on the second day at 2048 m
Severe hypoxemia
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.
Time frame: Approximately 72 hours (day 1 to 3 at 2048 m)
Subjective sleep quality visual analog scale score
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.
Time frame: Approximately 8 hours (during the second night at 2048 m)