Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

NCT01427192 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-12-12

No results posted yet for this study

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

Conditions

  • Pulmonary Hypertension
  • Breathing-Related Sleep Disorder

Interventions

DRUG

acetazolamide

250 mg bid

OTHER

Supplemental oxygen

Oxygen deliverded by nasal cannula

PROCEDURE

Non-invasive ventilation

Bi-level non-invasive ventilation via nasal mask

OTHER

Room air

Room air applied via sham oxygen concentrator

DRUG

Placebo tablet

Placebo tablet (Mannitol) similar to acetazolamide

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • 01 Studienregister MasterAdmins · UniversitaetsSpital Zuerich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01427192 on ClinicalTrials.gov