- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150616
Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep
February 5, 2020 updated by: University of Zurich
Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zurich, Switzerland, CH-8091
- University Hospital Zurich, Pulmonary Division
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Moderate altitude sojourn
Sojourn at moderate altitude (2048 m)
|
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Other Names:
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Other Names:
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Other Names:
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
Other Names:
|
EXPERIMENTAL: Low altitude sojourn
Sojourn at low altitude (490 m, baseline)
|
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Other Names:
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Other Names:
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Other Names:
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
Other Names:
|
ACTIVE_COMPARATOR: Oxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
|
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Other Names:
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Other Names:
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Other Names:
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
Other Names:
|
PLACEBO_COMPARATOR: Sham oxygen (room air)
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
|
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Other Names:
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Other Names:
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Other Names:
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean nocturnal oxygen saturation measured by pulse oximetry
Time Frame: 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.
|
Approximately 8 hours (during the first night at 2048 m)
|
Apnea/hypopnea index measured by polysomnography
Time Frame: 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.
|
Approximately 8 hours (during the first night at 2048 m)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean nocturnal oxygen saturation measured by pulse oximetry
Time Frame: 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.
|
Approximately 8 hours (during the second night at 2048 m)
|
Apnea/hypopnea index measured by polygraphy
Time Frame: 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.
|
Approximately 8 hours (during the second night at 2048 m)
|
Sleep quality visual analog scale score
Time Frame: 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.
|
Approximately 8 hours (during the first night at 2048 m)
|
Psychomotor vigilance test reaction time
Time Frame: Approximately at 10 a.m. on the second day at 2048 m
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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.
|
Approximately at 10 a.m. on the second day at 2048 m
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Severe hypoxemia
Time Frame: Approximately 72 hours, Day 1 to 3 at 2048 m
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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.
|
Approximately 72 hours, Day 1 to 3 at 2048 m
|
Subjective sleep quality visual analog scale score
Time Frame: 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.
|
Approximately 8 hours (during the second night at 2048 m)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
December 1, 2020
Study Registration Dates
First Submitted
May 18, 2014
First Submitted That Met QC Criteria
May 27, 2014
First Posted (ESTIMATE)
May 30, 2014
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Hypertension
- Lung Diseases
- Hypertension, Pulmonary
- Lung Diseases, Interstitial
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Sevoflurane
Other Study ID Numbers
- ID 2013-0088V2A3D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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