Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-03 @ 12:11 PM
Study NCT ID:
NCT02809859
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2016-06-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CPAP In-home Assessment USA
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': 'CPAP.TRIAL@fphcare.co.nz', 'phone': '+64 9 574 0123', 'title': 'Clinical Research Scientist', 'phoneExt': '7044', 'organization': 'Fisher & Paykel Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the study period of each participant (i.e. 6 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Investigational CPAP Device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device\n\nFisher \\& Paykel Healthcare CPAP Device: Fisher \\& Paykel Healthcare CPAP Device', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 0, 'seriousNumAtRisk': 139, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Community acquired pneumonia', 'notes': 'Community acquired pneumonia assessed to be unrelated to trial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'notes': 'Atrial Fibrillation assessed to be unrelated to trial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational CPAP Device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device\n\nFisher \\& Paykel Healthcare CPAP Device: Fisher \\& Paykel Healthcare CPAP Device'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'events/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational CPAP Device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device\n\nFisher \\& Paykel Healthcare CPAP Device: Fisher \\& Paykel Healthcare CPAP Device'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Machine Reported Faults, Measured as Number of Patients With Machine Faults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational CPAP Device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device\n\nFisher \\& Paykel Healthcare CPAP Device: Fisher \\& Paykel Healthcare CPAP Device'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participant Reported Faults, Measured as Number of Participant Complaints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational CPAP Device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device\n\nFisher \\& Paykel Healthcare CPAP Device: Fisher \\& Paykel Healthcare CPAP Device'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'complaints', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational CPAP Device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device\n\nFisher \\& Paykel Healthcare CPAP Device: Fisher \\& Paykel Healthcare CPAP Device'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Investigational CPAP Device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device\n\nFisher \\& Paykel Healthcare CPAP Device: Fisher \\& Paykel Healthcare CPAP Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Investigational CPAP Device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device\n\nFisher \\& Paykel Healthcare CPAP Device: Fisher \\& Paykel Healthcare CPAP Device'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': "Age wasn't provided by one of the participants"}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-21', 'size': 696042, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-08T16:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2016-06-19', 'resultsFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2016-06-19', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-12', 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.', 'timeFrame': '6 months'}, {'measure': 'Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults', 'timeFrame': '6 months'}, {'measure': 'Machine Reported Faults, Measured as Number of Patients With Machine Faults', 'timeFrame': '6 months'}, {'measure': 'Participant Reported Faults, Measured as Number of Participant Complaints', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.', 'detailedDescription': 'Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 22 and over\n* Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)\n* For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.\n\nExclusion Criteria:\n\n* Contraindicated for PAP (CPAP or AutoCPAP) therapy\n* Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)\n* Has obesity hypoventilation syndrome or congestive heart failure\n* Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device\n* Has implanted electronic medical devices (e.g cardiac pacemakers)\n* Pregnant or think they may be pregnant\n* Not fluent in spoken and written English.'}, 'identificationModule': {'nctId': 'NCT02809859', 'briefTitle': 'CPAP In-home Assessment USA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'CPAP In-home Assessment USA', 'orgStudyIdInfo': {'id': 'CIA176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational CPAP device', 'description': 'Fisher \\& Paykel Healthcare CPAP Device', 'interventionNames': ['Device: Fisher & Paykel Healthcare CPAP Device']}], 'interventions': [{'name': 'Fisher & Paykel Healthcare CPAP Device', 'type': 'DEVICE', 'description': 'Fisher \\& Paykel Healthcare CPAP Device', 'armGroupLabels': ['Investigational CPAP device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Sleep Clinic', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Pulmonary Disease Specialists - Central Florida Sleep Centre', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '63143', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clayton Sleep Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine and Neurosciences Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}], 'overallOfficials': [{'name': 'Matt Uhles', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clayton Sleep Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}