Clinical trial NCT02150616: Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep
Official title: Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Precapillary Pulmonary Hypertension
Interstitial Lung Disease
Keywords: Pulmonary hypertension
Interstitial lung disease
Pulmonary fibrosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: Approximately 8 hours (during the first night at 2048 m)
measure: Apnea/hypopnea index measured by polysomnography
timeFrame: Approximately 8 hours (during the first night at 2048 m)
Secondary outcomes:
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: Approximately 8 hours (during the second night at 2048 m)
measure: Apnea/hypopnea index measured by polygraphy
timeFrame: Approximately 8 hours (during the second night at 2048 m)
measure: Sleep quality visual analog scale score
timeFrame: Approximately 8 hours (during the first night at 2048 m)
measure: Psychomotor vigilance test reaction time
timeFrame: Approximately at 10 a.m. on the second day at 2048 m
measure: Severe hypoxemia
timeFrame: Approximately 72 hours, Day 1 to 3 at 2048 m
measure: Subjective sleep quality visual analog scale score
timeFrame: Approximately 8 hours (during the second night at 2048 m)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References: