Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-03-03 @ 3:54 PM
Study NCT ID:
NCT03124069
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2017-04-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
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Participants will be using the trial nasal mask during this treatment arm.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Comfort Compared to Their Usual Mask.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F&P Nasal', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.\n\n.'}], 'classes': [{'title': 'Much better', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Better', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Comfort reported from participants questionnaires to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants PAP Device Performance Reporting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F&P Nasal', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.\n\n.'}], 'classes': [{'title': 'Better than usual mask', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Same as usual mask', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Worse than usual mask', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'No data', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Determined from data recorded from the PAP device to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Subjective Performance Rating of the Nasal Mask', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F&P Nasal', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.'}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Very Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Performance reported from participants questionnaires to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Subjective Reporting of Nasal Mask Usability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F&P Nasal', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.'}], 'classes': [{'title': 'Very Easy', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Easy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Difficult', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Very Difficult', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Visit Two - 20 minutes', 'description': 'Usability reported from participants questionnaires to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Subjective Recording of Ease of Nasal Mask Use.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F&P Nasal Mask', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.'}], 'classes': [{'title': 'Very Easy', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Easy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Difficult', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Very Difficult', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Ease of use reported from participants questionnaires to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Leak Compared to Usual Mask', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F&P Nasal', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.\n\n.'}], 'classes': [{'title': 'No Data', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Better than current mask', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Same as current mask', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Worse than current mask', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Leak data recorded from PAP device to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Correct Nasal Mask Size Determination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F&P Nasal Mask', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.'}], 'classes': [{'title': 'Correct', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'In between sizes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Incorrect', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day-time appointment (1 hour)', 'description': 'Sizing determined from a customized fitting tool to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'F&P Nasal Mask', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'F&P Nasal', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-12', 'size': 4130219, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-24T20:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'After a period of baseline, all enrolled participants will be put on the same trial mask.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2019-02-07', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-24', 'studyFirstSubmitDate': '2017-04-11', 'dispFirstSubmitQcDate': '2021-06-24', 'resultsFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2017-04-18', 'dispFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-24', 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Comfort Compared to Their Usual Mask.', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Comfort reported from participants questionnaires to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea'}, {'measure': 'Number of Participants PAP Device Performance Reporting', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Determined from data recorded from the PAP device to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea'}, {'measure': 'Number of Participants Subjective Performance Rating of the Nasal Mask', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Performance reported from participants questionnaires to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea'}, {'measure': 'Number of Participants Subjective Reporting of Nasal Mask Usability', 'timeFrame': 'During Visit Two - 20 minutes', 'description': 'Usability reported from participants questionnaires to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea'}, {'measure': 'Number of Participants Subjective Recording of Ease of Nasal Mask Use.', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Ease of use reported from participants questionnaires to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Leak Compared to Usual Mask', 'timeFrame': '14 ± 5 days In-Home', 'description': 'Leak data recorded from PAP device to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea'}, {'measure': 'Number of Participants With Correct Nasal Mask Size Determination', 'timeFrame': '1 day-time appointment (1 hour)', 'description': 'Sizing determined from a customized fitting tool to evaluate the use of the F\\&P nasal mask for treatment of Obstructive Sleep Apnea'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.', 'detailedDescription': "The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited\n\nThis study will involve a baseline (Visit One) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.\n\nThe mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea.\n\nNeither the investigators nor the participants will be blinded to the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AHI ≥ 5 from diagnostic PSG night\n* Aged 22 and over (FDA defined as adult)\n* Either prescribed APAP, CPAP or Bi-Level PAP for OSA\n* Existing nasal or nasal pillows mask users (preferable 70%:30% split)\n* Fluent in spoken and written English\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Patient intolerant to CPAP therapy\n* Anatomical or physiological conditions making PAP therapy inappropriate\n* Current diagnosis of respiratory disease or CO2 retention\n* Pregnant or think they may be pregnant'}, 'identificationModule': {'nctId': 'NCT03124069', 'briefTitle': 'A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'CIA-211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F&P Saturn', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.', 'interventionNames': ['Device: F&P Saturn']}], 'interventions': [{'name': 'F&P Saturn', 'type': 'DEVICE', 'description': 'Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.', 'armGroupLabels': ['F&P Saturn']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33186', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Trials of Florida', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared with any other researchers or parties.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}