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

NCT02150616 | Unknown Phase 4

• 1 other identifier: ID 2013-0088V2A3D
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Precapillary Pulmonary Hypertension; Interstitial Lung Disease

Keywords

Pulmonary hypertension; Interstitial lung disease; Pulmonary fibrosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Mean nocturnal oxygen saturation measured by pulse oximetry

  Approximately 8 hours (during the second night at 2048 m)

• Apnea/hypopnea index measured by polygraphy

  Approximately 8 hours (during the second night at 2048 m)

• Sleep quality visual analog scale score

  Approximately 8 hours (during the first night at 2048 m)

• Psychomotor vigilance test reaction time

  Approximately at 10 a.m. on the second day at 2048 m

• Severe hypoxemia

  Approximately 72 hours, Day 1 to 3 at 2048 m

Study Arms (4)

Moderate altitude sojourn

EXPERIMENTAL

Sojourn at moderate altitude (2048 m)

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)

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

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

Behavioral: Moderate altitude sojourn; Behavioral: Low altitude sojourn; Drug: Oxygen; Drug: Sham oxygen (room air)

Interventions

Moderate altitude sojourn BEHAVIORAL

Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days

Also known as: Moderate altitude sojourn at 2048 m for 2 days

Low altitude sojourn; Moderate altitude sojourn; Oxygen; Sham oxygen (room air)

Low altitude sojourn BEHAVIORAL

Low altitude baseline evaluations will be performed during a stay at Zurich (490)

Also known as: Low altitude sojourn at 490 m (Zurich) for 1.5 days

Low altitude sojourn; Moderate altitude sojourn; Oxygen; Sham oxygen (room air)

Oxygen DRUG

Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Also known as: Nocturnal nasal oxygen administration during stay at 2048 m

Low altitude sojourn; Moderate altitude sojourn; Oxygen; Sham oxygen (room air)

Sham oxygen (room air) DRUG

Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Also known as: Nocturnal nasal room air administration

Low altitude sojourn; Moderate altitude sojourn; Oxygen; Sham oxygen (room air)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Precapillary pulmonary hypertension, or interstitial lung disease.
• New York Heart Association class 2-3.
• Residence at low altitude (\<800m).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Hypertension, Pulmonary; Pulmonary Fibrosis

Interventions

WW Domain-Containing Oxidoreductase; Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Konrad E Bloch, MD

  University Hospital, Zürich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2014
• First Posted: May 30, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-01

Locations

CH (1)