Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT02055027
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2014-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients.
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': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-03', 'studyFirstSubmitDate': '2014-02-03', 'studyFirstSubmitQcDate': '2014-02-03', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hours of CPAP use by night', 'timeFrame': 'Baseline', 'description': 'Analyse of the data recorded by the CPAP microchip in order to assess the adherent or non-adherent status to the patient (adherent: CPAP use \\> 4 hours per night, non-adherent: less than 4 hours)'}], 'secondaryOutcomes': [{'measure': "Lickert's scale to assess criteria of non-adherence", 'timeFrame': 'Baseline', 'description': "Evaluation of 72 criteria by a Lickert's scale in order to assess characteristics associated with non-adherence to CPAP therapy"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep Apnea, Obstructive', 'Continuous Positive Airway Pressure', 'Perioperative Period'], 'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'Prospective study designed to identify factors that would predict patient adherence to CPAP (Continuous Positive Airway Pressure) therapy.', 'detailedDescription': 'Prospective study designed to identify factors that would predict patient adherence to CPAP therapy.\n\nComparison between data recorded among patients and the data of the CPAP microchip.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sleep Study Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\> 18 patients)\n* All patients under CPAP (Continuous Positive Airway Pressure) therapy coming for annual visit in the Sart-Tilman Sleep Study Center\n\nExclusion Criteria:\n\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT02055027', 'briefTitle': 'Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Astes'}, 'officialTitle': 'Adherence to Continuous Positive Airway Pressure Among Obstructive Sleep Apnoea Patients. An Anaesthetic Algorithmic Approach to Prevent Postoperative Complications.', 'orgStudyIdInfo': {'id': 'ASTES-NCPAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adherent Patients', 'description': 'Comparison between groups', 'interventionNames': ['Other: Comparison between groups']}, {'label': 'Non-adherent patients', 'description': 'Comparison between groups', 'interventionNames': ['Other: Comparison between groups']}], 'interventions': [{'name': 'Comparison between groups', 'type': 'OTHER', 'description': 'Comparison between the two groups (adherent and non-adherent patients) in order to discover criteria of non-adherence', 'armGroupLabels': ['Adherent Patients', 'Non-adherent patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Liege', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire (CHU) Sart-Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Eric Deflandre, MD, FCCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Astes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Eric DEFLANDRE, MD, FCCP', 'investigatorFullName': 'Eric DEFLANDRE, MD, FCCP', 'investigatorAffiliation': 'Astes'}}}}