Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-04-22 @ 5:09 PM
Study NCT ID:
NCT02331992
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2015-01-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Positive Airway Pressure Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cpaptrial@fphcare.co.nz', 'phone': '+64 9 5740123', 'title': 'Clinical Research Scientist', 'organization': 'Fisher & Paykel Healthcare'}, 'certainAgreement': {'otherDetails': 'The PI agrees to supply the sponsor with any proposed publications or presentation. Any information that affect the sponsor IP, or information that is commercially sensitive, may be delayed, deleted or amended.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Positive Airway Pressure Adherence Program', 'description': 'Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.\n\nAdherence program: Participants will receive supportive messages while enrolled in the program.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 1, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participant Providing Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Airway Pressure Adherence Program', 'description': 'Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.\n\nAdherence program: Participants will receive supportive messages while enrolled in the program.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Participants will be provided questionnaires so as to provide program feedback.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Healthcare Provider Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Airway Pressure Adherence Program', 'description': 'Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.\n\nAdherence program: Participants will receive supportive messages while enrolled in the program.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Healthcare providers will be provided questionaires so as to provide program feedback.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Positive Airway Pressure Adherence Program', 'description': 'Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.\n\nAdherence program: Participants will receive supportive messages while enrolled in the program.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Positive Airway Pressure Adherence Program', 'description': 'Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.\n\nAdherence program: Participants will receive supportive messages while enrolled in the program.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-04', 'studyFirstSubmitDate': '2015-01-04', 'resultsFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-04', 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Providing Feedback', 'timeFrame': '1 month', 'description': 'Participants will be provided questionnaires so as to provide program feedback.'}], 'secondaryOutcomes': [{'measure': 'Healthcare Provider Feedback', 'timeFrame': '1 month', 'description': 'Healthcare providers will be provided questionaires so as to provide program feedback.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Continuous Positive Airway Pressure'], 'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting around 2-4% of the middle aged population and is characterized by periodic collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal.\n\nOver the past decade, considerable research has focused on determining the factors responsible for poor CPAP adherence. Two key areas have been identified: patient-reported symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the importance of patient education and support. In addition we know that the patient experience during the crucial first days and weeks of their journey predicts longer term adherence.\n\nThis study investigates the ability of an automated program that assists patients towards continuous positive airway pressure (CPAP) therapy adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18years of age\n* Diagnosed with OSA (AHI \\>5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements\n* Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years\n* Own a mobile phone, and has reliable mobile network coverage at their home.\n* Either: the participant will use a modem; OR the participant has access to a home internet connection (either their own, or a neighbours or friend etc) and is willing to perform a home upload.\n\nExclusion Criteria:\n\n* Contraindicated for CPAP therapy\n* Medically unstable condition/diagnosis that is not yet under control\n* Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)\n* Periodic Limb Movement Arousal Index (PLMA) greater than 15/hr during the diagnostic study'}, 'identificationModule': {'nctId': 'NCT02331992', 'briefTitle': 'Positive Airway Pressure Program', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'Positive Airway Pressure Program', 'orgStudyIdInfo': {'id': 'CIA-146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive airway pressure adherence program', 'description': 'Participants will be enrolled in the automated adherence program and will receive supportive messages while they use CPAP as prescribed by their healthcare provider. These messages are designed to aid the participant towards therapy adherence.', 'interventionNames': ['Behavioral: Adherence program']}], 'interventions': [{'name': 'Adherence program', 'type': 'BEHAVIORAL', 'description': 'Participants will receive supportive messages while enrolled in the program.', 'armGroupLabels': ['Positive airway pressure adherence program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Sleep Clinic', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '62223', 'city': 'Belleville', 'state': 'Illinois', 'country': 'United States', 'facility': 'IV Care & Respiratory', 'geoPoint': {'lat': 38.52005, 'lon': -89.98399}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'SleepMed of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Hamish Collie, MHlthSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Fisher & Paykel Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}