Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT04854694
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Product Testing of the FaceView Mask™: Usability Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeannehahne@gmail.com', 'phone': '4155188574', 'title': 'Jeanne Hahne, MSN, RN', 'organization': 'FaceView Mask, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'Exclusionary criteria were provided and the masks evaluated were not in a clinical environment', 'eventGroups': [{'id': 'EG000', 'title': 'Transparent Mask', 'description': 'Wore FaceView Mask which is the transparent mask', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 0, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Transparent Mask', 'description': 'Wore 3M N95 mask which is the non-transparent mask', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 0, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ease of Understanding Another Person', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transparent Mask', 'description': 'Wore FaceView Mask which is the transparent mask'}, {'id': 'OG001', 'title': 'Non-Transparent Mask', 'description': 'Wore 3M N95 mask which is the non-transparent mask'}], 'classes': [{'categories': [{'title': 'Difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Somewhat difficult', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'title': 'Somewhat easy', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Easy', 'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Difficult\n2. Somewhat difficult\n3. Somewhat easy\n4. Easy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fit of the Mask', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transparent Mask', 'description': 'Wore FaceView Mask which is the transparent mask'}, {'id': 'OG001', 'title': 'Non-Transparent Mask', 'description': 'Wore 3M N95 mask which is the non-transparent mask'}], 'classes': [{'categories': [{'title': 'Extremely small', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Slightly too small', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Fits well', 'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}, {'title': 'Slightly too large', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Extremely large', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Extremely small\n2. Slightly too small\n3. Fits well\n4. Slightly too large\n5. Extremely large', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comfort of the Mask', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transparent Mask', 'description': 'Wore FaceView Mask which is the transparent mask'}, {'id': 'OG001', 'title': 'Non-Transparent Mask', 'description': 'Wore 3M N95 mask which is the non-transparent mask'}], 'classes': [{'categories': [{'title': 'Not comfortable at all', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Slightly comfortable', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}, {'title': 'Very comfortable', 'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}, {'title': 'Extremely comfortable', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Not comfortable at all\n2. Slightly comfortable\n3. Very comfortable\n4. Extremely comfortable', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transparent Mask', 'description': 'Wore FaceView Mask which is the transparent mask'}, {'id': 'OG001', 'title': 'Non-Transparent Mask', 'description': 'Wore 3M N95 mask which is the non-transparent mask'}], 'classes': [{'categories': [{'title': 'Not easy at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'Slightly breathable', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}, {'title': 'Very breathable', 'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'title': 'Extremely breathable', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Not easy at all\n2. Slightly breathable\n3. Very breathable\n4. Extremely breathable', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Speaking/Communicating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transparent Mask', 'description': 'Wore FaceView Mask which is the transparent mask'}, {'id': 'OG001', 'title': 'Non-Transparent Mask', 'description': 'Wore 3M N95 mask which is the non-transparent mask'}], 'classes': [{'categories': [{'title': 'Difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Somewhat difficult', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Somewhat easy', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Easy', 'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Difficult\n2. Somewhat difficult\n3. Somewhat easy\n4. Easy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transparent Mask First, Then Non-Transparent Mask', 'description': 'Participants completed fit testing protocol using the transparent mask first, followed by the same fit testing protocol with a non-transparent mask, then completed a questionnaire.'}, {'id': 'FG001', 'title': 'Non-Transparent Mask First, Then Transparent Mask', 'description': 'Participants completed fit testing protocol using the non-transparent mask first, followed by the same fit testing protocol with a transparent mask, then completed a questionnaire.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'All participants will be fit tested for the masks to ensure that the appropriate size is used. Some participants will wear the FaceView Mask™ (first) for 5 minutes before wearing the conventional surgical N95 respirator for 5 minutes. Others will wear the conventional surgical N95 respirator (first) for 5 minutes before wearing the FaceView Mask™ for 5 minutes.\n\nAll subjects will complete the study survey after exposure to the interventions.\n\nFaceView Mask™: transparent surgical N95 respirator designed to improve communication\n\nconventional surgical N95 respirator: standard N95 respirator'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '198', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Intersex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Prefer Not to Say', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Female, Male, Intersex, Prefer Not to Say', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '173', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'At the outset of the study, we permitted participants to select male, female, intersex, or prefer not to say.', 'unitOfMeasure': 'Participants', 'populationDescription': 'One participant identified as Intersex'}, {'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': '2023-01-13', 'size': 181408, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-07T13:54', 'hasProtocol': True}, {'date': '2023-01-13', 'size': 385206, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-07T10:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2021-04-16', 'resultsFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-24', 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ease of Understanding Another Person', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Difficult\n2. Somewhat difficult\n3. Somewhat easy\n4. Easy'}], 'secondaryOutcomes': [{'measure': 'Fit of the Mask', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Extremely small\n2. Slightly too small\n3. Fits well\n4. Slightly too large\n5. Extremely large'}, {'measure': 'Comfort of the Mask', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Not comfortable at all\n2. Slightly comfortable\n3. Very comfortable\n4. Extremely comfortable'}, {'measure': 'Ease of Breathing', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Not easy at all\n2. Slightly breathable\n3. Very breathable\n4. Extremely breathable'}, {'measure': 'Ease of Speaking/Communicating', 'timeFrame': '1 day', 'description': 'As recorded on the survey\n\n1. Difficult\n2. Somewhat difficult\n3. Somewhat easy\n4. Easy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['lip reading', 'face mask'], 'conditions': ['Hearing Disability']}, 'descriptionModule': {'briefSummary': "The study aims to gather participants' perceptions of the novel transparent surgical N95 respirator vs. a conventional surgical N95 respirator. Following fitting of the masks, participants will complete a questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to communication.", 'detailedDescription': "The investigators will recruit adult participants to complete a usability survey on a transparent surgical N95 respirator (i.e., FaceView mask) designed to improve communication. The study aims to gather participants' perceptions of the novel transparent surgical N95 respirator vs. a conventional surgical N95 respirator. Following fitting of the masks (5 minutes wear time each), the participants will complete a questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to communication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A goal of 200 participants is desired with a minimum of 125 to meet study targets. We will be contacting known persons (not cold contacts) with ability to share study brochure by e-mail:\n\n1. across the UAMS campus (e.g., College Deans, Center Directors, Program Directors);\n2. surrounding clinics;\n3. American Sign Language interpreter education at the University of Arkansas at Little Rock (Program Director)\n4. Arkansas School for the Deaf (Superintendent and/or Assistant to the Superintendent); and\n5. Communications Plus+ Interpreter Services, Inc. (owner and operator)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years old\n* have no health conditions that would prevent them from safely wearing an N95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease)\n* read in English and communicate in English or American Sign Language\n* be able to provide or arrange their own transportation to the study location\n\nExclusion Criteria:\n\n* Children are to be excluded from the proposed research project because the current FaceView Mask™ is designed for adults\n* Adults who are non-English communicators\n* Any adult with health conditions that would prevent them from safely wearing an N95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease)'}, 'identificationModule': {'nctId': 'NCT04854694', 'briefTitle': 'Product Testing of the FaceView Mask™: Usability Survey', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Product Testing of the FaceView Mask™: Usability Survey', 'orgStudyIdInfo': {'id': '262478'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Subjects', 'description': 'All participants will be fit tested for the masks to ensure that the appropriate size is used. Some participants will wear the FaceView Mask™ (first) for 5 minutes before wearing the conventional surgical N95 respirator for 5 minutes. Others will wear the conventional surgical N95 respirator (first) for 5 minutes before wearing the FaceView Mask™ for 5 minutes.\n\nAll subjects will complete the study survey after exposure to the interventions.', 'interventionNames': ['Device: FaceView Mask™', 'Device: conventional surgical N95 respirator']}], 'interventions': [{'name': 'FaceView Mask™', 'type': 'DEVICE', 'description': 'transparent surgical N95 respirator designed to improve communication', 'armGroupLabels': ['All Subjects']}, {'name': 'conventional surgical N95 respirator', 'type': 'DEVICE', 'description': 'standard N95 respirator', 'armGroupLabels': ['All Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Samuel R Atcherson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}