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Clinical Trials/NCT01870830
NCT01870830
Completed
Not Applicable

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

University of Zurich1 site in 1 country50 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
University of Zurich
Enrollment
50
Locations
1
Primary Endpoint
Change in mean nocturnal oxygen saturation from baseline measured at 490 m
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 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

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

apnea/hypopnea index measured by polysomnography

Secondary Outcomes

  • 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)
  • 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)
  • 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)
  • Change in reaction time from baseline measured at 490 m(Change in reaction time from 490 m baseline during 2 days at 1650 m)

Study Sites (1)

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