Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep

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
• Conditions: Interstitial Lung Disease; Precapillary Pulmonary Hypertension
• Intervention / Treatment: Behavioral: Moderate altitude sojourn; Behavioral: Low altitude sojourn; Drug: Oxygen; Drug: Sham oxygen (room air)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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	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	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	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	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

• Sponsor: University of Zurich

Study record dates

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

• Keywords: Pulmonary hypertension; Interstitial lung disease; Pulmonary fibrosis
• 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