Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension
NCT ID: NCT01427192
Last Updated: 2012-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2010-11-30
2012-12-31
Brief Summary
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* Trial with medicinal product
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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acetazolamide
1 week therapy, cross-over design
acetazolamide
250 mg bid
Placebo tablet
One week, cross-over design
Placebo tablet
Placebo tablet (Mannitol) similar to acetazolamide
supplemental oxygen during nights
One week, cross-over design
Supplemental oxygen
Oxygen deliverded by nasal cannula
Non-invasive ventilation
One week, cross-over design
Non-invasive ventilation
Bi-level non-invasive ventilation via nasal mask
room air
room air applied via sham-oxygen-concentrator
Room air
Room air applied via sham oxygen concentrator
Interventions
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acetazolamide
250 mg bid
Supplemental oxygen
Oxygen deliverded by nasal cannula
Non-invasive ventilation
Bi-level non-invasive ventilation via nasal mask
Room air
Room air applied via sham oxygen concentrator
Placebo tablet
Placebo tablet (Mannitol) similar to acetazolamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* sleep disordered breathing with apnea/hypopnea index \> 10 events/h and/or median nocturnal oxygen saturation \<90%
Exclusion Criteria
* severe daytime hypoxemia (PaO2 \< 7.2 kPA)
* patients with predominantly obstructive sleep apnea.
20 Years
80 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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01 Studienregister MasterAdmins
Role: STUDY_DIRECTOR
UniversitaetsSpital Zuerich
Locations
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Respiratory Clinic, University Hospital of Zurich
Zurich, Canton of Zurich, Switzerland
Countries
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References
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Ulrich S, Fischler M, Speich R, Bloch KE. Sleep-related breathing disorders in patients with pulmonary hypertension. Chest. 2008 Jun;133(6):1375-1380. doi: 10.1378/chest.07-3035. Epub 2008 Mar 13.
Schumacher DS, Muller-Mottet S, Hasler ED, Hildenbrand FF, Keusch S, Speich R, Bloch KE, Ulrich S. Effect of oxygen and acetazolamide on nocturnal cardiac conduction, repolarization, and arrhythmias in precapillary pulmonary hypertension and sleep-disturbed breathing. Chest. 2014 Nov;146(5):1226-1236. doi: 10.1378/chest.14-0495.
Ulrich S, Keusch S, Hildenbrand FF, Lo Cascio C, Huber LC, Tanner FC, Speich R, Bloch KE. Effect of nocturnal oxygen and acetazolamide on exercise performance in patients with pre-capillary pulmonary hypertension and sleep-disturbed breathing: randomized, double-blind, cross-over trial. Eur Heart J. 2015 Mar 7;36(10):615-23. doi: 10.1093/eurheartj/eht540. Epub 2013 Dec 23.
Other Identifiers
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CSRPH
Identifier Type: -
Identifier Source: org_study_id