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

Sponsor

University of Zurich (Other)

Overall Status

Completed

CT.gov ID

NCT02150590

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

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

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Oct 31, 2014

Actual Study Completion Date :

Oct 31, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Nocturnal nasal room air during stay at 2048 m

Arm

Intervention/Treatment

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 Names:

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 Names:

Nocturnal nasal room air during stay at 2048 m

Outcome Measures

Primary Outcome Measures

Mean nocturnal oxygen saturation measured by pulse oximetry [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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