Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

Phase 2

Completed

• Conditions: Pulmonary Hypertension; Breathing-Related Sleep Disorder
• Interventions: Drug: Placebo tablet; Drug: acetazolamide; Other: Supplemental oxygen; Procedure: Non-invasive ventilation; Other: Room air

• Registration Number: NCT01427192
• Lead Sponsor: University of Zurich

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-14
• Status Verified: 2011-08
• Study First Submitted QC: 2011-08-31
• Study First Posted: 2011-09-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo tablet	Placebo tablet	One week, cross-over design
acetazolamide	acetazolamide	1 week therapy, cross-over design
supplemental oxygen during nights	Supplemental oxygen	One week, cross-over design
Non-invasive ventilation	Non-invasive ventilation	One week, cross-over design
room air	Room air	room air applied via sham-oxygen-concentrator

Primary Outcome Measures

Name	Time	Method
exercise capacity	1 week	Assessment by the 6 minute walk distance
Quality of Life	1 week	Assessment by the short form of the SF 36 questionnaire

Secondary Outcome Measures

Name	Time	Method
sleep related breathing disorders	1 week	assessed by polysomnography according to standard techniques
hemodynamics measured by echocardiography	1 week	right ventricular dimension right ventricular over right atrial pressure
venous blood analysis	1 week	C reactive protein NT-proBNP IL-6
Nocturnal oxygen desaturation	1 week	Assessed by fingertip puleoxymetry
arterial blood analysis	1 week	oxygenation electrolytes
Vigilance	1 week	Assessed by the MURT test

Trial Locations

Locations (1)

Respiratory Clinic, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland