Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-30 @ 7:08 AM
Study NCT ID:
NCT01427192
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}, {'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-11', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-08-31', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise capacity', 'timeFrame': '1 week', 'description': 'Assessment by the 6 minute walk distance'}, {'measure': 'Quality of Life', 'timeFrame': '1 week', 'description': 'Assessment by the short form of the SF 36 questionnaire'}], 'secondaryOutcomes': [{'measure': 'sleep related breathing disorders', 'timeFrame': '1 week', 'description': 'assessed by polysomnography according to standard techniques'}, {'measure': 'hemodynamics measured by echocardiography', 'timeFrame': '1 week', 'description': 'right ventricular dimension right ventricular over right atrial pressure'}, {'measure': 'venous blood analysis', 'timeFrame': '1 week', 'description': 'C reactive protein NT-proBNP IL-6'}, {'measure': 'Nocturnal oxygen desaturation', 'timeFrame': '1 week', 'description': 'Assessed by fingertip puleoxymetry'}, {'measure': 'arterial blood analysis', 'timeFrame': '1 week', 'description': 'oxygenation electrolytes'}, {'measure': 'Vigilance', 'timeFrame': '1 week', 'description': 'Assessed by the MURT test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breathing-Related Sleep Disorder', 'Pulmonary Hypertension'], 'conditions': ['Pulmonary Hypertension', 'Breathing-Related Sleep Disorder']}, 'referencesModule': {'references': [{'pmid': '18339776', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24991933', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '24366914', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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\n\n* Trial with medicinal product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* percapillary pulmonary hypertension diagnosed by right heart catheterisation -- stable therapy and clinical condition for at least 4 weeks\n* sleep disordered breathing with apnea/hypopnea index \\> 10 events/h and/or median nocturnal oxygen saturation \\<90%\n\nExclusion criteria:\n\n* Pregnancy\n* severe daytime hypoxemia (PaO2 \\< 7.2 kPA)\n* patients with predominantly obstructive sleep apnea.'}, 'identificationModule': {'nctId': 'NCT01427192', 'acronym': 'CSRPH', 'briefTitle': 'Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)', 'orgStudyIdInfo': {'id': 'CSRPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'acetazolamide', 'description': '1 week therapy, cross-over design', 'interventionNames': ['Drug: acetazolamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tablet', 'description': 'One week, cross-over design', 'interventionNames': ['Drug: Placebo tablet']}, {'type': 'EXPERIMENTAL', 'label': 'supplemental oxygen during nights', 'description': 'One week, cross-over design', 'interventionNames': ['Other: Supplemental oxygen']}, {'type': 'EXPERIMENTAL', 'label': 'Non-invasive ventilation', 'description': 'One week, cross-over design', 'interventionNames': ['Procedure: Non-invasive ventilation']}, {'type': 'SHAM_COMPARATOR', 'label': 'room air', 'description': 'room air applied via sham-oxygen-concentrator', 'interventionNames': ['Other: Room air']}], 'interventions': [{'name': 'acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox'], 'description': '250 mg bid', 'armGroupLabels': ['acetazolamide']}, {'name': 'Supplemental oxygen', 'type': 'OTHER', 'otherNames': ['Oxygen concentrator'], 'description': 'Oxygen deliverded by nasal cannula', 'armGroupLabels': ['supplemental oxygen during nights']}, {'name': 'Non-invasive ventilation', 'type': 'PROCEDURE', 'description': 'Bi-level non-invasive ventilation via nasal mask', 'armGroupLabels': ['Non-invasive ventilation']}, {'name': 'Room air', 'type': 'OTHER', 'description': 'Room air applied via sham oxygen concentrator', 'armGroupLabels': ['room air']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'description': 'Placebo tablet (Mannitol) similar to acetazolamide', 'armGroupLabels': ['Placebo tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Respiratory Clinic, University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': '01 Studienregister MasterAdmins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UniversitaetsSpital Zuerich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}