Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 1:33 PM
Study NCT ID:
NCT01064258
Status:
COMPLETED
Last Update Posted:
2010-02-16
First Post:
2010-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Auto Continuous Positive Airway Pressure (CPAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-15', 'studyFirstSubmitDate': '2010-02-04', 'studyFirstSubmitQcDate': '2010-02-05', 'lastUpdatePostDateStruct': {'date': '2010-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained', 'timeFrame': 'one night'}], 'secondaryOutcomes': [{'measure': 'reasons for pressure increase and consequences of the increase on sleep continuity', 'timeFrame': 'one night'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treatment', 'CPAP', 'sleep apnea'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '21632834', 'type': 'DERIVED', 'citation': 'Mwenge GB, Dury M, Delguste P, Rodenstein D. Response of automatic continuous positive airway pressure devices in a normal subject. Eur Respir J. 2011 Jun;37(6):1530-3. doi: 10.1183/09031936.00139510. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Background: In patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autoCPAP) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. Once breathing becomes normal, pressure slowly declines. AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.', 'detailedDescription': "Material and Methods: We will submit one normal (confirmed with two polysomnographies, PSG) subject to a double blind study. Pairs of PSG will be performed on successive days once a week, one night with a 4 cm water fixed pressure CPAP device, previously shown not to disturb the subject's sleep and breathing, the other night with one of five well known autoCPAP devices programmed to work between 4 and 15 cm H2O pressure. The same mask and headgear will be used throughout the study. The subject and the physicians reading the tracings will ignore which device is being used on which night."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal subject\n* male and female\n* age 18 to 65 years old\n\nExclusion Criteria:\n\n* obstructive sleep apnea\n* unable to sleep with a CPAP device'}, 'identificationModule': {'nctId': 'NCT01064258', 'briefTitle': 'Trial of Auto Continuous Positive Airway Pressure (CPAP)', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study', 'orgStudyIdInfo': {'id': '2007/30MARS/67'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fixed CPAP', 'description': 'subject will sleep with a fixed CPAP device at minimal pressure', 'interventionNames': ['Device: CPAP']}, {'type': 'EXPERIMENTAL', 'label': 'autoCPAP', 'description': 'the subject will sleep connected to an autoCPAP device', 'interventionNames': ['Device: autoCPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'CPAP at 4 cm H2O', 'armGroupLabels': ['fixed CPAP']}, {'name': 'autoCPAP', 'type': 'DEVICE', 'description': 'autoCPAP working between 4 and 15 cm H2O', 'armGroupLabels': ['autoCPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Daniel Rodenstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Daniel Rodenstein MD', 'oldOrganization': 'Cliniques universitaires Saint-Luc'}}}}