Clinical trial NCT01870830: Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude
Official title: Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean nocturnal oxygen saturation from baseline measured at 490 m
timeFrame: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 2590 m
measure: Change in apnea/hypopnea index from baseline measured at 490 m
timeFrame: Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m
Secondary outcomes:
measure: Change in mean nocturnal oxygen saturation from baseline measured at 490 m
timeFrame: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 1650 m
measure: Change in apnea/hypopnea index from baseline measured at 490 m
timeFrame: Change in apnea/hypopnea index from 490 m baseline during stay at 1650 m
measure: Change in subjective sleep quality from baseline measured at 490 m
timeFrame: Change in subjective sleep quality from 490 m during 2 days at 2590 m
measure: Change in subjective sleep quality from baseline measured at 490 m
timeFrame: Change in subjective sleep quality from 490 m baseline during 2 days at 1650 m
measure: Change in reaction time from baseline measured at 490 m
timeFrame: Change in reaction time from 490 m baseline during 2 days at 2590 m
measure: Change in reaction time from baseline measured at 490 m
timeFrame: Change in reaction time from 490 m baseline during 2 days at 1650 m
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University Hsopital Zurich, Switzerland
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: University Hospital, Zürich
name: Tsogyal D Latshang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Latshang TD, Tardent RPM, Furian M, Flueck D, Segitz SD, Mueller-Mottet S, Kohler M, Ulrich S, Bloch KE. Sleep and breathing disturbances in patients with chronic obstructive pulmonary disease traveling to altitude: a randomized trial. Sleep. 2019 Jan 1;42(1). doi: 10.1093/sleep/zsy203.