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Completed

NCT Number: NCT01870830

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Altitude exposure

Other

Stay at different altitudes: 490, 1650, 2590 m

Primary outcomes

  1. 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

  2. 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

  1. 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 1650 m

    apnea/hypopnea measured by polysomnography

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

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

    apnea/hypopnea index measured by polysomnography

  3. Change in subjective sleep quality from baseline measured at 490 m

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

    Visual analog scale of sleep quality

  4. Change in subjective sleep quality from baseline measured at 490 m

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

    Visual analog scale of sleep quality

  5. Change in reaction time from baseline measured at 490 m

    Time frame: Change in reaction time from 490 m baseline during 2 days at 2590 m

    psychomotor vigilance test reaction time

  6. Change in reaction time from baseline measured at 490 m

    Time frame: Change in reaction time from 490 m baseline during 2 days at 1650 m

    Psychomotor vigilance test reaction time

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2013
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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