Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension
Information source: University of Zurich
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Hypertension; Breathing-Related Sleep Disorder
Intervention: acetazolamide (Drug); Supplemental oxygen (Other); Non-invasive ventilation (Procedure); Room air (Other); Placebo tablet (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Zurich Official(s) and/or principal investigator(s): 01 Studienregister MasterAdmins, Study Director, Affiliation: UniversitaetsSpital Zuerich
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
Clinical Details
Official title: Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: exercise capacityQuality of Life
Secondary outcome: sleep related breathing disordershemodynamics measured by echocardiography venous blood analysis Nocturnal oxygen desaturation arterial blood analysis Vigilance
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Respiratory Clinic, University Hospital of Zurich, Zurich 8091, Switzerland
Additional Information
Related publications: Ulrich S, Fischler M, Speich R, Bloch KE. Sleep-related breathing disorders in patients with pulmonary hypertension. Chest. 2008 Jun;133(6):1375-80. doi: 10.1378/chest.07-3035. Epub 2008 Mar 13.
Starting date: November 2010
Last updated: December 11, 2012
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