Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease (copd)?

You may be eligible to participate in a chronic obstructive pulmonary disease (copd) clinical trial.

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease (copd)? You may be eligible to participate in a chronic obstructive pulmonary disease (copd) clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial in Zurich

NCT02150590 | Phase 4 | Interventional

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease (copd)?

You may be eligible to participate in a chronic obstructive pulmonary disease (copd) clinical trial.

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease (copd)? You may be eligible to participate in a chronic obstructive pulmonary disease (copd) clinical trial.

Completed

Male & Female

18 - 75

Years old

This study has recruited 32 Participants

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.

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Details for the study

Brief Title

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

Official Title

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

Brief Summary

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

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).

Treatments and/or Procedures

Oxygen

Nocturnal nasal oxygen during stay at 2048 m

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Apnea/hypopnea index measured by polysomnography

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.

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

Primary

Mean nocturnal oxygen saturation measured by pulse oximetry

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.

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

Secondary

Subjective sleep quality visual analog scale score

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.

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

Secondary

Severe hypoxemia

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.

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

Secondary

Subjective sleep quality visual analog scale score

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.

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

Secondary

Apnea/hypopnea index measured by polygraphy

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.

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

Secondary

Mean nocturnal oxygen saturation measured by pulse oximetry

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.

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

Secondary

Psychomotor vigilance test reaction time

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.

Approximately at 10 a.m. on the second day at 2048 m

Study 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