Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-11 @ 9:07 PM
Study NCT ID:
NCT01748656
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2012-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Target Volume in Noninvasive Positive Pressure Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}], 'ancestors': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-13', 'studyFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)', 'timeFrame': '1 night', 'description': 'transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.'}], 'secondaryOutcomes': [{'measure': 'Mean transcutaneous CO2 pressure during REM Sleep', 'timeFrame': '1 Night'}, {'measure': 'Mean nocturnal SpO2', 'timeFrame': '1 night'}, {'measure': 'Awake arterial PaCO2 after 1 hour of NIPPV withdrawal', 'timeFrame': 'After 1 night'}, {'measure': 'Micro-arousals/hour of sleep', 'timeFrame': '1 night'}, {'measure': 'Sleep Quality assess by Visual analogic scale (100mm)', 'timeFrame': '1 night'}, {'measure': 'Respiratory residual events detected by NIPPV built-in softwares', 'timeFrame': '1 Night'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Noninvasive ventilation', 'Obesity Hypoventilation Syndrome'], 'conditions': ['Obesity Hypoventilation Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option', 'detailedDescription': 'RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation)\n* 18 to 75 years old\n* In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).\n\nExclusion Criteria:\n\n* patient treated with additional long term Oxygen therapy\n* Patient previously treated by AVAPS mode or IVAPS mode'}, 'identificationModule': {'nctId': 'NCT01748656', 'acronym': 'CIBLE', 'briefTitle': 'Target Volume in Noninvasive Positive Pressure Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'AGIR à Dom'}, 'officialTitle': 'Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial', 'orgStudyIdInfo': {'id': '12-AGIR-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AVAPS', 'description': 'AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night', 'interventionNames': ['Device: IVAPS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IVAPS', 'description': 'IVAPS mode(STELAR 150-RESMED)1 night', 'interventionNames': ['Device: AVAPS']}], 'interventions': [{'name': 'IVAPS', 'type': 'DEVICE', 'description': 'IVAPS mode (RESMED Stelar 150) during 1 night', 'armGroupLabels': ['AVAPS']}, {'name': 'AVAPS', 'type': 'DEVICE', 'description': 'AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night', 'armGroupLabels': ['IVAPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38900', 'city': 'Grenoble', 'country': 'France', 'facility': 'Sleep Laboratory, Grenoble Univeristy Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean Louis Pepin, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Grenoble France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGIR à Dom', 'class': 'OTHER'}, 'collaborators': [{'name': 'ResMed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}