Interstitial Lung Disease, Precapillary Pulmonary Hypertension
Conditions
Keywords
Pulmonary hypertension, Interstitial lung disease, Pulmonary fibrosis
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.
Interventions
BEHAVIORALModerate altitude sojourn
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
BEHAVIORALLow altitude sojourn
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
DRUGOxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality visual analog scale score | Approximately 8 hours (during the first night 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. |
| Psychomotor vigilance test reaction time | Approximately at 10 a.m. on the second day at 2048 m | Difference in reaction time between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2048 m. |
| 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. |
| Subjective sleep quality visual analog scale score | Approximately 8 hours (during the second night 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 sojourn at 2048 m (altitude) and 490 m (baseline); and during 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. |
Countries
Switzerland
Outcome results
None listed