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

N/ACompletedNCT05089487

University of Zurich28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

High Altitude Pulmonary Hypertension Sleep

Interventions

Nocturnal rest (sleep study)PROCEDURE

Proportion of patients free of severe hypoxemia without oxygen therapy during nocturnal rest .

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Proportion of patients free of severe hypoxemia

Proportion of patients free of severe hypoxemia (defined as oxygenation (SpO2)\<80% for \>30 min) without oxygen therapy during nocturnal rest at 2500 m vs. 490 m

Time frame: 30 hours

Secondary Outcomes

Nocturnal oxygenation

Difference in mean nocturnal oxygenation (SpO2) 2500 m of high altitude vs 490 m low altitude

Time frame: 30 hours

Oxygen desaturation index

Difference in oxygen desaturation index sleeping at 2500 m high altitude vs 490 m low altitude

Time frame: 30 hours

Periodic breathing

Difference in time spent with periodic breathing in patients sleeping at 2500 m of high altitude vs 490 m low altitude

Time frame: 30 hours

Nocturnal transcutaneous carbon dioxide tension

Difference in nocturnal transcutaneous carbon dioxide tension in patients sleeping at 2500 m of high altitude vs 490 m low altitude

Time frame: 30 hours

Visual Analogue Scale

Subjective sleep quality Visual Analogue Scale score 2500 m high altitude vs 490 m low altitude

Time frame: 30 hours

Time spent awake during the night

Subjective time spent awake during the night high altitude vs 490 m low altitude

Time frame: 30 hours

Cerebral tissue deoxygenation

Data from ClinicalTrials.gov

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