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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Altitude exposure

• Registration Number: NCT01870830
• Lead Sponsor: University of Zurich

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
• residents at low altitude (<800 m)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C: intermediate-high-low altitude	Altitude exposure	Altitude exposure sequence C, 1650-2590-490m
A: low-intermediate-high altitude	Altitude exposure	Altitude exposure sequence A, 490-1650-2590m
B: low-high-intermediate altitude	Altitude exposure	Altitude exposure sequence B, 490-2590-1650m
D: high-intermediate-low altitude	Altitude exposure	Altitude exposure sequence D, 2590-1650-490m

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 reaction time from baseline measured at 490 m	Change in reaction time from 490 m baseline during 2 days at 1650 m	Psychomotor vigilance test reaction time
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 baseline during 2 days at 1650 m	Visual analog scale of sleep quality

Trial Locations

Locations (1)

University Hospital Zurich, Pulmonary Division; 🇨🇭 Zurich, Switzerland