Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep

NCT ID: NCT02150616

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-12-31

Brief Summary

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

Detailed Description

Patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), breathing and sleep during a 2 day sojourn at moderate altitude are impaired in comparison to low altitude; b), breathing and sleep during a 2 day sojourn at moderate altitude are improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 days 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). The order of stays at the different altitudes and of the treatments will be randomized.

Conditions

Precapillary Pulmonary Hypertension; Interstitial Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Moderate altitude sojourn

Sojourn at moderate altitude (2048 m)

Group Type: EXPERIMENTAL

Moderate altitude sojourn

Intervention Type: BEHAVIORAL

Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days

Low altitude sojourn

Intervention Type: BEHAVIORAL

Low altitude baseline evaluations will be performed during a stay at Zurich (490)

Oxygen

Intervention Type: DRUG

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

Sham oxygen (room air)

Intervention Type: DRUG

Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Low altitude sojourn

Sojourn at low altitude (490 m, baseline)

Group Type: EXPERIMENTAL

Moderate altitude sojourn

Intervention Type: BEHAVIORAL

Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days

Low altitude sojourn

Intervention Type: BEHAVIORAL

Low altitude baseline evaluations will be performed during a stay at Zurich (490)

Oxygen

Intervention Type: DRUG

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

Sham oxygen (room air)

Intervention Type: DRUG

Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Oxygen

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

Group Type: ACTIVE_COMPARATOR

Moderate altitude sojourn

Intervention Type: BEHAVIORAL

Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days

Low altitude sojourn

Intervention Type: BEHAVIORAL

Low altitude baseline evaluations will be performed during a stay at Zurich (490)

Oxygen

Intervention Type: DRUG

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

Sham oxygen (room air)

Intervention Type: DRUG

Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Sham oxygen (room air)

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

Group Type: PLACEBO_COMPARATOR

Moderate altitude sojourn

Intervention Type: BEHAVIORAL

Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days

Low altitude sojourn

Intervention Type: BEHAVIORAL

Low altitude baseline evaluations will be performed during a stay at Zurich (490)

Oxygen

Intervention Type: DRUG

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

Sham oxygen (room air)

Intervention Type: DRUG

Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Interventions

Moderate altitude sojourn

Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days

Intervention Type: BEHAVIORAL

Low altitude sojourn

Low altitude baseline evaluations will be performed during a stay at Zurich (490)

Intervention Type: BEHAVIORAL

Oxygen

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

Intervention Type: DRUG

Sham oxygen (room air)

Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Intervention Type: DRUG

Other Intervention Names

Moderate altitude sojourn at 2048 m for 2 days; Low altitude sojourn at 490 m (Zurich) for 1.5 days; Nocturnal nasal oxygen administration during stay at 2048 m; Nocturnal nasal room air administration

Eligibility Criteria

Inclusion Criteria

• Precapillary pulmonary hypertension, or interstitial lung disease.
• New York Heart Association class 2-3.
• Residence at low altitude (<800m).

Exclusion Criteria

• Unstable or exacerbated condition
• Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4
• requirement for oxygen therapy at low altitude residence
• hypoventilation
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad E Bloch, MD

Role: STUDY_CHAIR

University Hospital, Zürich

Locations

University Hospital Zurich, Pulmonary Division

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

ID 2013-0088V2A3D

Identifier Type: -

Identifier Source: org_study_id