Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

University of Zurich23 enrolled

Overview

The purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders * Trial with medicinal product

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pulmonary Hypertension Breathing-Related Sleep Disorder

Interventions

acetazolamideDRUG

250 mg bid

Supplemental oxygenOTHER

Oxygen deliverded by nasal cannula

Non-invasive ventilationPROCEDURE

Bi-level non-invasive ventilation via nasal mask

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: * percapillary pulmonary hypertension diagnosed by right heart catheterisation -- stable therapy and clinical condition for at least 4 weeks * sleep disordered breathing with apnea/hypopnea index \> 10 events/h and/or median nocturnal oxygen saturation \<90% Exclusion criteria: * Pregnancy * severe daytime hypoxemia (PaO2 \< 7.2 kPA) * patients with predominantly obstructive sleep apnea.

Locations (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

exercise capacity

Assessment by the 6 minute walk distance

Time frame: 1 week

Quality of Life

Assessment by the short form of the SF 36 questionnaire

Time frame: 1 week

Secondary Outcomes

sleep related breathing disorders

assessed by polysomnography according to standard techniques

Time frame: 1 week

hemodynamics measured by echocardiography

right ventricular dimension right ventricular over right atrial pressure

Time frame: 1 week

venous blood analysis

C reactive protein NT-proBNP IL-6

Time frame: 1 week

Nocturnal oxygen desaturation

Assessed by fingertip puleoxymetry

Time frame: 1 week

arterial blood analysis

oxygenation electrolytes

Time frame: 1 week

Vigilance

Assessed by the MURT test

Time frame: 1 week

Data from ClinicalTrials.gov

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