Nocturnal Breathing and Sleep in Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude

University of Zurich50 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Altitude exposureOTHER

Stay at different altitudes: 490, 1650, 2590 m

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Zurich, Pulmonary Division

Zurich, Switzerland

Outcomes

Primary Outcomes

Change in mean nocturnal oxygen saturation from baseline measured at 490 m

mean nocturnal oxygen saturation measured by pulse oximetry

Time frame: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 2590 m

Change in apnea/hypopnea index from baseline measured at 490 m

apnea/hypopnea index measured by polysomnography

Time frame: Change in apnea/hypopnea index from 490 m baseline during 2 days at 2590 m

Secondary Outcomes

Change in mean nocturnal oxygen saturation from baseline measured at 490 m

apnea/hypopnea measured by polysomnography

Time frame: Change in mean nocturnal oxygen saturation from 490 m baseline during 2 days at 1650 m

Change in apnea/hypopnea index from baseline measured at 490 m

apnea/hypopnea index measured by polysomnography

Time frame: Change in apnea/hypopnea index from 490 m baseline during stay at 1650 m

Change in subjective sleep quality from baseline measured at 490 m

Visual analog scale of sleep quality

Time frame: Change in subjective sleep quality from 490 m during 2 days at 2590 m

Change in subjective sleep quality from baseline measured at 490 m

Visual analog scale of sleep quality

Time frame: Change in subjective sleep quality from 490 m baseline during 2 days at 1650 m

Change in reaction time from baseline measured at 490 m

psychomotor vigilance test reaction time

Data from ClinicalTrials.gov

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