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

Interstitial Lung Disease Clinical Trial

Official title:

Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Breathing and Sleep

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02150616
• Other study ID #: ID 2013-0088V2A3D
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Precapillary Pulmonary Hypertension

Intervention

Behavioral:
• Moderate altitude sojourn
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
• Low altitude sojourn
Low altitude baseline evaluations will be performed during a stay at Zurich (490)

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)