Precapillary Pulmonary HypertensionPhase 4NCT02150616
Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep
A Phase 4 study testing Moderate altitude sojourn, Low altitude sojourn and Oxygen in people with Precapillary Pulmonary Hypertension and Interstitial Lung Disease, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Precapillary Pulmonary Hypertension, Interstitial Lung Disease
- What is being tested?
- Moderate altitude sojourn, Low altitude sojourn and Oxygen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Precapillary pulmonary hypertension, or interstitial lung disease.
- New York Heart Association class 2-3.
- Residence at low altitude (<800m).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Pulmonary Division
Zurich, CH-8091
About this study
Official title: 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.
Read the 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.
- Being tested
- Moderate altitude sojourn, Low altitude sojourn, Oxygen, Sham oxygen (room air)
- Keywords
- Pulmonary hypertension, Interstitial lung disease, Pulmonary fibrosis
- Medical subject headings
- Lung Diseases, Interstitial, Hypertension, Pulmonary, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate altitude sojournBehavioural
Also called Moderate altitude sojourn at 2048 m for 2 days
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Low altitude sojournBehavioural
Also called Low altitude sojourn at 490 m (Zurich) for 1.5 days
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
OxygenDrug
Also called Nocturnal nasal oxygen administration during stay at 2048 m
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Sham oxygen (room air)Drug
Also called Nocturnal nasal room air administration
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
| Study group | Role | What they receive |
|---|---|---|
| Moderate altitude sojourn | Experimental | Sojourn at moderate altitude (2048 m) Receives: Behavioral: Moderate altitude sojourn; Behavioral: Low altitude sojourn; Drug: Oxygen; Drug: Sham oxygen (room air) |
| Low altitude sojourn | Experimental | Sojourn at low altitude (490 m, baseline) Receives: Behavioral: Moderate altitude sojourn; Behavioral: Low altitude sojourn; Drug: Oxygen; Drug: Sham oxygen (room air) |
| Oxygen | Active comparator | Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Receives: Behavioral: Moderate altitude sojourn; Behavioral: Low altitude sojourn; Drug: Oxygen; Drug: Sham oxygen (room air) |
| Sham oxygen (room air) | Placebo comparator | Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights Receives: Behavioral: Moderate altitude sojourn; Behavioral: Low altitude sojourn; Drug: Oxygen; Drug: Sham oxygen (room air) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 8 hours (during the first night 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.
Measured: Approximately 8 hours (during the first night at 2048 m)
Secondary outcomes (6)
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.
Measured: Approximately 8 hours (during the second night 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.
Measured: Approximately 8 hours (during the second night 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.
Measured: Approximately 8 hours (during the first night 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.
Measured: Approximately at 10 a.m. on the second day 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.
Measured: Approximately 72 hours, Day 1 to 3 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.
Measured: Approximately 8 hours (during the second night at 2048 m)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precapillary Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, MD, Study chair, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150616
- Sponsor's protocol ID
- ID 2013-0088V2A3D
- Status last verified
- Jan 2020
- First submitted
- 18 May 2014
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep
- ClinicalTrials.gov ID
- NCT02150616
- Acronym / sponsor ID
- ID 2013-0088V2A3D
- Keywords
- Pulmonary hypertension, Interstitial lung disease, Pulmonary fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moderate altitude sojourn | Experimental | Behavioral: Moderate altitude sojourn, Behavioral: Low altitude sojourn, Drug: Oxygen, Drug: Sham oxygen (room air)Sojourn at moderate altitude (2048 m) |
| Low altitude sojourn | Experimental | Behavioral: Moderate altitude sojourn, Behavioral: Low altitude sojourn, Drug: Oxygen, Drug: Sham oxygen (room air)Sojourn at low altitude (490 m, baseline) |
| Oxygen | Active comparator | Behavioral: Moderate altitude sojourn, Behavioral: Low altitude sojourn, Drug: Oxygen, Drug: Sham oxygen (room air)Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m |
| Sham oxygen (room air) | Placebo comparator | Behavioral: Moderate altitude sojourn, Behavioral: Low altitude sojourn, Drug: Oxygen, Drug: Sham oxygen (room air)Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Precapillary pulmonary hypertension, or interstitial lung disease.
- New York Heart Association class 2-3.
- Residence at low altitude (<800m).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate altitude sojournAlso: Moderate altitude sojourn at 2048 m for 2 daysParticipants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days | Behavioural | Low altitude sojourn, Moderate altitude sojourn, Oxygen, Sham oxygen (room air) |
| Low altitude sojournAlso: Low altitude sojourn at 490 m (Zurich) for 1.5 daysLow altitude baseline evaluations will be performed during a stay at Zurich (490) | Behavioural | Low altitude sojourn, Moderate altitude sojourn, Oxygen, Sham oxygen (room air) |
| OxygenAlso: Nocturnal nasal oxygen administration during stay at 2048 mOxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m | Drug | Low altitude sojourn, Moderate altitude sojourn, Oxygen, Sham oxygen (room air) |
| Sham oxygen (room air)Also: Nocturnal nasal room air administrationSham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m | Drug | Low altitude sojourn, Moderate altitude sojourn, Oxygen, Sham oxygen (room air) |
Primary outcome
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.
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.
6 secondary outcomes
Mean nocturnal oxygen saturation measured by pulse oximetry
Time frame: 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)
Sleep quality visual analog scale score
Time frame: 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
Severe hypoxemia
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konrad E Bloch, MD study chair
University Hospital, Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moderate altitude sojourn, Low altitude sojourn and Oxygen in people with Precapillary Pulmonary Hypertension and Interstitial Lung Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean nocturnal oxygen saturation measured by pulse oximetry (time frame: Approximately 8 hours (during the first night at 2048 m)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.