Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-20 @ 10:46 AM
Study NCT ID:
NCT02930460
Status:
TERMINATED
Last Update Posted:
2020-02-28
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2016-10-11', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance', 'timeFrame': '3 months', 'description': 'hours of usage of the device per night'}], 'secondaryOutcomes': [{'measure': 'sleepiness', 'timeFrame': '3 months', 'description': 'Epworth sleepiness score evolution'}, {'measure': 'sleep quality', 'timeFrame': '3 months', 'description': 'Pittsburgh sleep questionnaire index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM', 'detailedDescription': 'To characterize, in routine practice, non compliant patient to continuous positive airway pressure who can get a benefit of a bilevel positive airway pressure therapy as a second line treatment (Aircurve 10 VAutoTM ) To evaluate the clinical management of obstructive sleep apnea patients treated by Aircurve 10 VAutoTM , especially impact on compliance and residual apnea hypopnea Index.\n\nTo evaluate Aircurve 10 VAutoTM benefit on quality of Life and quality of sleep'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obstructive sleep apnea patient, non compliant or intolerant to Continous positive Airway Pressure therapy, treated by Bilevel Positive Airway Pressure (Aircurve 10 VAutoTM ) as second line therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Obstructive Sleep Apnea Patient previously treated by Continuous positive airway pressure non-compliant to therapy\n* Patient naive of bilevel Positive Airway Pressure therapy\n\nExclusion Criteria:\n\n* Bilevel positive airway pressure Contraindication\n* Severe respiratory disease diagnostic'}, 'identificationModule': {'nctId': 'NCT02930460', 'acronym': 'PoP IN VAuto', 'briefTitle': 'Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure, Treated With Bilevel Positive Airway Pressure (AirCurve 10 VAutoTM) as Second-line Therapy: PoP IN VAuto', 'orgStudyIdInfo': {'id': 'PoP IN VAuto'}}, 'contactsLocationsModule': {'locations': [{'city': 'Belfort', 'country': 'France', 'facility': 'CH de Belfort', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'city': 'Biarritz', 'country': 'France', 'facility': 'Clinique Aguilera', 'geoPoint': {'lat': 43.48055, 'lon': -1.55684}}, {'city': 'Blois', 'country': 'France', 'facility': 'Cabinet de Pneumologie', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'HCL - Croix-Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'APHM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Metz', 'country': 'France', 'facility': 'Centre médical du sommeil', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35706', 'city': 'Rennes', 'country': 'France', 'facility': 'Polyclinique Saint-Laurent', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Alain Palot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}