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

University of Zurich (UZH)

Status and phase: Unknown; Phase 4

Conditions: Precapillary Pulmonary Hypertension; Interstitial Lung Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02150616

ID 2013-0088V2A3D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

50 participants in 4 patient groups, including a placebo group

Moderate altitude sojourn

Experimental group

Description:

Sojourn at moderate altitude (2048 m)

Treatment:

Drug: Sham oxygen (room air)

Drug: Oxygen

Behavioral: Low altitude sojourn

Behavioral: Moderate altitude sojourn

Low altitude sojourn

Experimental group

Description:

Sojourn at low altitude (490 m, baseline)

Treatment:

Drug: Sham oxygen (room air)

Drug: Oxygen

Behavioral: Low altitude sojourn

Behavioral: Moderate altitude sojourn

Oxygen

Active Comparator group

Description:

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

Treatment:

Drug: Sham oxygen (room air)

Drug: Oxygen

Behavioral: Low altitude sojourn

Behavioral: Moderate altitude sojourn

Sham oxygen (room air)

Placebo Comparator group

Description:

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

Treatment:

Drug: Sham oxygen (room air)

Drug: Oxygen

Behavioral: Low altitude sojourn

Behavioral: Moderate altitude sojourn