Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-02-23 @ 8:30 PM
Study NCT ID:
NCT02809794
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2016-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPAP In-home Assessment Australia
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2016-06-19', 'studyFirstSubmitQcDate': '2016-06-19', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea Hypopnea Index (AHI), measured as number of events/hour', 'timeFrame': '6 months', 'description': 'Obtained from the device'}, {'measure': 'Log of safety-related events, measured as number of safety-related faults', 'timeFrame': '6 months', 'description': 'Obtained from the device'}, {'measure': 'Machine reported faults, measured as number of machine faults', 'timeFrame': '6 months', 'description': 'Obtained from the device'}, {'measure': 'Participant reported faults, measured as number of participant complaints', 'timeFrame': '6 months', 'description': 'Obtained from the follow up visits'}], 'secondaryOutcomes': [{'measure': 'Perception of the device, measured through questionnaire', 'timeFrame': '6 months', 'description': 'Impression of the device during the follow up visits'}]}, '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': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 and over.\n* Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.\n\nExclusion Criteria:\n\n* Persons contraindicated for Continuous Positive Airway Pressure (CPAP) therapy.\n* Persons with other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea).\n* Persons with obesity hypoventilation syndrome or congestive heart failure.\n* Persons that require supplemental oxygen with their CPAP device.\n* Persons with implanted electronic medical devices (e.g. cardiac pacemakers).\n* Persons who are pregnant or think they might be pregnant.\n* Persons whose primary language is other than English.\n* Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.\n* Persons highly dependent on medical care.\n* People with cognitive impairment, an intellectual disability or a mental illness'}, 'identificationModule': {'nctId': 'NCT02809794', 'briefTitle': 'CPAP In-home Assessment Australia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'CPAP In-home Assessment Australia', 'orgStudyIdInfo': {'id': 'CIA175'}}, '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': '3105', 'city': 'Bulleen', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Sleep Matters', 'geoPoint': {'lat': -37.76667, 'lon': 145.08333}}, {'zip': '6230', 'city': 'Bunbury', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sleep & Snore Solutions', 'geoPoint': {'lat': -33.32711, 'lon': 115.64137}}, {'zip': '6056', 'city': 'Midland', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'St John of God Midland Public Hospital', 'geoPoint': {'lat': -31.88909, 'lon': 116.0107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}