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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: sham oxygen (room air); Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02150590

2013-0088V2A3B

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Oxygen

Active Comparator group

Description:

oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Treatment:

Drug: Oxygen

Drug: sham oxygen (room air)

Sham oxygen

Placebo Comparator group

Description:

Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Treatment:

Drug: Oxygen

Drug: sham oxygen (room air)