Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-11 @ 11:39 AM
Study NCT ID:
NCT02540603
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
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': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-18', 'studyFirstSubmitDate': '2015-08-28', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with average system leak >60L/min', 'timeFrame': 'Two weeks in-home use', 'description': 'Average system leak will be recorded through downloading of the data from the PAP device in L/min.'}], 'secondaryOutcomes': [{'measure': 'Insights into mask fitting and removal.', 'timeFrame': 'Two weeks use', 'description': 'Observations of the action of fitting the mask and removing the mask will be noted.'}, {'measure': 'Number of participants that found the mask comfortable.', 'timeFrame': 'Two weeks in-home use', 'description': 'Subjective feedback on comfort will be measured through questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': "This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.", 'detailedDescription': "A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. Participants will be on the trial for three weeks, using the prototypes at home for two weeks. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for one week prior to mask fitting with the full face trial mask."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18+ years of age\n* Diagnosed with OSA by a practicing physician\n* Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))\n* Existing full face users\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Patients who are in a coma or decreased level of consciousness\n* Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)\n* Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)\n* Current diagnosis of CO2 retention\n* Pregnant or think they may be pregnant'}, 'identificationModule': {'nctId': 'NCT02540603', 'briefTitle': 'Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ', 'orgStudyIdInfo': {'id': 'CIA-179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full Face Mask', 'description': 'F\\&P Jupiter Full Face Mask with Headgear', 'interventionNames': ['Device: F&P Jupiter Full Face Mask']}], 'interventions': [{'name': 'F&P Jupiter Full Face Mask', 'type': 'DEVICE', 'otherNames': ['Jupiter Mask'], 'description': 'Investigative F\\&P Jupiter full face mask to be used for OSA therapy', 'armGroupLabels': ['Full Face Mask']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared to any other parties.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}