Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-28 @ 7:30 AM
Study NCT ID:
NCT02741635
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2016-04-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
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': 'christine.lambert@fphcare.co.nz', 'phone': '+64 9 574 0123', 'title': 'Christine Lambert', 'phoneExt': '7172', 'organization': 'Fisher & Paykel Healthcare Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Toffee Nasal Pillows Mask', 'description': 'Participants to use nasal pillows mask one night in lab overnight polysomnography.\n\nToffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Toffee Nasal Pillows Mask', 'description': 'Participants to use nasal pillows mask one night in lab overnight polysomnography.\n\nNew Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Toffee Nasal Pillows Mask', 'description': 'Participants to use nasal pillows mask one night in lab overnight polysomnography.\n\nNew Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Toffee Nasal Pillows Mask', 'description': 'Participants to use nasal pillows mask one night in lab overnight polysomnography.\n\nToffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Toffee Nasal Pillows Mask', 'description': 'Participants to use nasal pillows mask one night in lab overnight polysomnography.\n\nNew Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Toffee Nasal Pillows Mask', 'description': 'Participants to use nasal pillows mask one night in lab overnight polysomnography.\n\nToffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18+ years of age', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2016-04-06', 'resultsFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2016-04-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-04', 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks', 'timeFrame': '12 hours'}], 'secondaryOutcomes': [{'measure': 'Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask', 'timeFrame': '12 hours'}, {'measure': 'Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask', 'timeFrame': '12 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': "This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy.\n\nA total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \\& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).\n\nParticipants will undergo an overnight polysomnography session at the Fisher \\& Paykel Healthcare sleep lab.\n\nThe participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18+ years of age)\n* Able to give consent\n* AHI ≥ 5 on diagnostic night\n* Prescribed a CPAP device after successful OSA diagnosis\n* Existing nasal pillows mask user\n\nExclusion Criteria:\n\n* Inability to give consent\n* Patients who are in a coma or a decreased level of consciousness.\n* Anatomical or physiological conditions making APAP therapy inappropriate\n* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)\n* Current diagnosis of CO2 retention\n* Pregnant or may think they are pregnant.'}, 'identificationModule': {'nctId': 'NCT02741635', 'briefTitle': 'The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ', 'orgStudyIdInfo': {'id': 'CIA-190'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New Nasal Pillows Mask', 'description': 'Participants to use nasal pillows mask one night in lab overnight polysomnography.', 'interventionNames': ['Device: New Nasal Pillows Mask']}], 'interventions': [{'name': 'New Nasal Pillows Mask', 'type': 'DEVICE', 'description': 'Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)', 'armGroupLabels': ['New Nasal Pillows Mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2013', 'city': 'Auckland', 'state': 'East Tamaki', 'country': 'New Zealand', 'facility': 'Fisher & Paykel Healthcare Ltd', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Bhavi Ogra, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sponsor Employee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'For product development purposes only. Data will be de-identified.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}