Back to resultsPatients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep
Primary Purpose
Precapillary Pulmonary Hypertension, Interstitial Lung Disease
Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Moderate altitude sojourn
Low altitude sojourn
Oxygen
Sham oxygen (room air)
Sponsored by
About this trial
This is an interventional treatment trial for Precapillary Pulmonary Hypertension focused on measuring Pulmonary hypertension, Interstitial lung disease, Pulmonary fibrosis
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
Sites / Locations
- University Hospital Zurich, Pulmonary Division
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Moderate altitude sojourn
Low altitude sojourn
Oxygen
Sham oxygen (room air)
Arm Description
Sojourn at moderate altitude (2048 m)
Sojourn at low altitude (490 m, baseline)
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
Outcomes
Primary Outcome Measures
Mean nocturnal oxygen saturation measured by pulse oximetry
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
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 Outcome Measures
Mean nocturnal oxygen saturation measured by pulse oximetry
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 polygraphy
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.
Sleep quality visual analog scale score
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
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.
Severe hypoxemia
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.
Subjective sleep quality visual analog scale score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02150616
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precapillary Pulmonary Hypertension, Interstitial Lung Disease
Keywords
Pulmonary hypertension, Interstitial lung disease, Pulmonary fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderate altitude sojourn
Arm Type
Experimental
Arm Description
Sojourn at moderate altitude (2048 m)
Arm Title
Low altitude sojourn
Arm Type
Experimental
Arm Description
Sojourn at low altitude (490 m, baseline)
Arm Title
Oxygen
Arm Type
Active Comparator
Arm Description
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Arm Title
Sham oxygen (room air)
Arm Type
Placebo Comparator
Arm Description
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
Intervention Type
Behavioral
Intervention Name(s)
Moderate altitude sojourn
Other Intervention Name(s)
Moderate altitude sojourn at 2048 m for 2 days
Intervention Description
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Intervention Type
Behavioral
Intervention Name(s)
Low altitude sojourn
Other Intervention Name(s)
Low altitude sojourn at 490 m (Zurich) for 1.5 days
Intervention Description
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
Nocturnal nasal oxygen administration during stay at 2048 m
Intervention Description
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Intervention Type
Drug
Intervention Name(s)
Sham oxygen (room air)
Other Intervention Name(s)
Nocturnal nasal room air administration
Intervention Description
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
Primary Outcome Measure Information:
Title
Mean nocturnal oxygen saturation measured by pulse oximetry
Description
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.
Time Frame
Approximately 8 hours (during the first night at 2048 m)
Title
Apnea/hypopnea index measured by polysomnography
Description
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.
Time Frame
Approximately 8 hours (during the first night at 2048 m)
Secondary Outcome Measure Information:
Title
Mean nocturnal oxygen saturation measured by pulse oximetry
Description
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.
Time Frame
Approximately 8 hours (during the second night at 2048 m)
Title
Apnea/hypopnea index measured by polygraphy
Description
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.
Time Frame
Approximately 8 hours (during the second night at 2048 m)
Title
Sleep quality visual analog scale score
Description
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.
Time Frame
Approximately 8 hours (during the first night at 2048 m)
Title
Psychomotor vigilance test reaction time
Description
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.
Time Frame
Approximately at 10 a.m. on the second day at 2048 m
Title
Severe hypoxemia
Description
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.
Time Frame
Approximately 72 hours, Day 1 to 3 at 2048 m
Title
Subjective sleep quality visual analog scale score
Description
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.
Time Frame
Approximately 8 hours (during the second night at 2048 m)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Zurich, Pulmonary Division
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
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Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep
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