NCT02150616

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

Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Moderate altitude sojourn	Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
BEHAVIORAL	Low altitude sojourn	Low altitude baseline evaluations will be performed during a stay at Zurich (490)
DRUG	Oxygen	Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
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

Timeline

• Start date: 2014-05-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2014-05-30
• Last updated: 2020-02-06

Locations

1 site across 1 country: Switzerland