Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-03 @ 10:18 PM
Study NCT ID:
NCT02323035
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigative Headgear With CPAP Mask
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005115', 'term': 'Extraoral Traction Appliances'}], 'ancestors': [{'id': 'D009968', 'term': 'Orthodontic Appliances, Removable'}, {'id': 'D009967', 'term': 'Orthodontic Appliances'}, {'id': 'D009970', 'term': 'Orthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants perception of the headgear on mask performance', 'timeFrame': '2-4 weeks', 'description': 'Assess if the headgear with mask changes the perception of the performance of the mask.'}], 'secondaryOutcomes': [{'measure': 'Number of participants that choose this Headgear over their usual.', 'timeFrame': '2-4 weeks', 'description': 'Assess the acceptability of the headgear with mask.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.', 'detailedDescription': 'Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AHI≥5 from the diagnostic night\n* ≥18 years of age\n* Prescribed CPAP or Bilevel therapy for OSA\n* Existing CPAP mask users\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Patient intolerant to PAP\n* Anatomical or physiological conditions making PAP therapy inappropriate\n* History of respiratory disease or CO2 retention.\n* Pregnant or think they may be pregnant\n* Investigated by Land Transport Safety Authority'}, 'identificationModule': {'nctId': 'NCT02323035', 'briefTitle': 'Investigative Headgear With CPAP Mask', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'Investigative Headgear With CPAP Mask', 'orgStudyIdInfo': {'id': 'CIA150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Headgear', 'description': 'Investigative Headgear with CPAP Mask.', 'interventionNames': ['Device: Headgear']}], 'interventions': [{'name': 'Headgear', 'type': 'DEVICE', 'description': 'Investigative Headgear with CPAP Mask.', 'armGroupLabels': ['Headgear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2013', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Fisher & Paykel Healthcare', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Bhavi Ogra, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Scientist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}