Skip to main content
OpenTrials
Completed

NCT Number: NCT02150590

Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Breathing and Sleep

The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung disease.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Bronchial Diseases Bronchitis Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

About this study

Patients with moderate to severe chronic obstructive pulmonary disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypothesis that nocturnal breathing and sleep during nights spent at moderate altitude are improved by oxygen therapy via a nasal cannula compared to room air (sham oxygen). Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 nights each spent at moderate altitude (St. Moritz Salastrains, 2048 m) separated by a wash-out period of at least 2 weeks spent at low altitude (<800 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

Oxygen

Drug

Nocturnal nasal oxygen during stay at 2048 m

sham oxygen (room air)

Drug

Other names: Nocturnal nasal room air during stay at 2048 m

Primary outcomes

  1. Mean nocturnal oxygen saturation measured by pulse oximetry

    Time frame: Approximately 8 hours (during the first night at 2048 m)

    Difference in mean nocturnal oxygen saturation between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

  2. Apnea/hypopnea index measured by polysomnography

    Time frame: Approximately 8 hours (during the first night at 2048 m)

    Difference in apnea/hypopnea index between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

Secondary outcomes

  1. Mean nocturnal oxygen saturation measured by pulse oximetry

    Time frame: Approximately 8 hours (during the second night at 2048 m)

    Difference in mean nocturnal oxygen saturation between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

  2. Apnea/hypopnea index measured by polygraphy

    Time frame: Approximately 8 hours (during the second night at 2048 m)

    Difference in apnea/hypopnea index between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

  3. Subjective sleep quality visual analog scale score

    Time frame: Approximately 8 hours (during the first night at 2048 m)

    Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

  4. Psychomotor vigilance test reaction time

    Time frame: Approximately at 10 a.m. on the second day at 2048 m

    Difference in subjective sleep quality between visual analog scale measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

  5. Severe hypoxemia

    Time frame: Approximately 72 hours (day 1 to 3 at 2048 m)

    Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.

  6. Subjective sleep quality visual analog scale score

    Time frame: Approximately 8 hours (during the second night at 2048 m)

    Difference in subjective sleep quality visual analog scale scores between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep in

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 30, 2014
Registry last updated
Jan 29, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.