Nocturnal Oxygenation and Sleep-related Breathing Disorders During the First Night of a Stay at 2500m of High Altitude in Patients With Precapillary Pulmonary Hypertension

University of Zurich (UZH)

Status: Completed

Conditions: Sleep; High Altitude Pulmonary Hypertension

Treatments: Procedure: Nocturnal rest (sleep study)

Study type: Interventional

Funder types: Other

Identifiers

NCT05089487

OVERALP II E

Details and patient eligibility

About

The impact of hypoxia at 2500m of high altitude on sleep in patients with precapillary pulmonary hypertension

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent as documented by signature (Appendix Informed Consent Form)
• PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion criteria

• resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
• exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
• inability to follow the procedures of the study
• other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

High altitude 2500 m above sea level

Experimental group

Treatment:

Procedure: Nocturnal rest (sleep study)

Low altitude 470 m above sea level

Active Comparator group

Treatment:

Procedure: Nocturnal rest (sleep study)