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

This study is currently recruiting participants.
Verified May 2017 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT02150590
First Posted: May 30, 2014
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Oxygen Drug: sham oxygen (room air) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patients With Chronic Obstructive Pulmonary Disease Staying at Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep in

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxygen
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Drug: Oxygen
Nocturnal nasal oxygen during stay at 2048 m
Drug: sham oxygen (room air)
Other Name: Nocturnal nasal room air during stay at 2048 m
Placebo Comparator: Sham oxygen
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Drug: Oxygen
Nocturnal nasal oxygen during stay at 2048 m
Drug: sham oxygen (room air)
Other Name: Nocturnal nasal room air during stay at 2048 m

Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • pregnant or nursing patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150590


Contacts
Contact: Konrad E Bloch, MD +41 44 255 3828 konrad.bloch@usz.ch
Contact: Tsogyal D Latshang, MD +41 44 255 3828 tsogyal.latshang@usz.ch

Locations
Switzerland
University Hospital Zurich, Pulmonary Division Recruiting
Zurich, Switzerland, CH-8091
Contact: Konrad E Bloch, MD    +41 33 255 3828    konrad.bloch@usz.ch   
Contact: Tsogyal D Latshang, MD    +41 33 255 3828    tsogyal.latshang@usz.ch   
Principal Investigator: Konrad E Bloch, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Study Chair: Konrad E Bloch, MD University Hospital, Zürich
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02150590     History of Changes
Other Study ID Numbers: 2013-0088V2A3B
First Submitted: May 18, 2014
First Posted: May 30, 2014
Last Update Posted: May 25, 2017
Last Verified: May 2017

Keywords provided by University of Zurich:
airway disease
bronchitis
emphysema
lung

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases