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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • University Hospital Zurich, Pulmonary Division

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Moderate altitude sojourn
Sojourn at moderate altitude (2048 m)
Behavioral: Moderate altitude sojourn
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Other Names:
  • Moderate altitude sojourn at 2048 m for 2 days
Behavioral: Low altitude sojourn
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Other Names:
  • Low altitude sojourn at 490 m (Zurich) for 1.5 days
Drug: Oxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Other Names:
  • Nocturnal nasal oxygen administration during stay at 2048 m
Drug: Sham oxygen (room air)
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:
  • Nocturnal nasal room air administration
EXPERIMENTAL: Low altitude sojourn
Sojourn at low altitude (490 m, baseline)
Behavioral: Moderate altitude sojourn
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Other Names:
  • Moderate altitude sojourn at 2048 m for 2 days
Behavioral: Low altitude sojourn
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Other Names:
  • Low altitude sojourn at 490 m (Zurich) for 1.5 days
Drug: Oxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Other Names:
  • Nocturnal nasal oxygen administration during stay at 2048 m
Drug: Sham oxygen (room air)
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:
  • Nocturnal nasal room air administration
ACTIVE_COMPARATOR: Oxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Behavioral: Moderate altitude sojourn
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Other Names:
  • Moderate altitude sojourn at 2048 m for 2 days
Behavioral: Low altitude sojourn
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Other Names:
  • Low altitude sojourn at 490 m (Zurich) for 1.5 days
Drug: Oxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Other Names:
  • Nocturnal nasal oxygen administration during stay at 2048 m
Drug: Sham oxygen (room air)
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:
  • Nocturnal nasal room air administration
PLACEBO_COMPARATOR: Sham oxygen (room air)
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
Behavioral: Moderate altitude sojourn
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
Other Names:
  • Moderate altitude sojourn at 2048 m for 2 days
Behavioral: Low altitude sojourn
Low altitude baseline evaluations will be performed during a stay at Zurich (490)
Other Names:
  • Low altitude sojourn at 490 m (Zurich) for 1.5 days
Drug: Oxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Other Names:
  • Nocturnal nasal oxygen administration during stay at 2048 m
Drug: Sham oxygen (room air)
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:
  • Nocturnal nasal room air administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
Severe hypoxemia
Time Frame: 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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings