Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-13 @ 3:41 AM
Study NCT ID:
NCT03628456
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2018-08-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of HFCWO Vests on Spirometry Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'quality@biophysicscorp.com', 'phone': '512-804-0046', 'title': 'VP of Engineering and Quality', 'organization': 'International Biophysics Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Baseline', 'description': 'Patient baseline result', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AffloVest Arm', 'description': 'AffloVest placed on highest intensity', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Monarch Arm', 'description': 'Monarch placed on highest intensity', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Patient baseline result'}, {'id': 'OG001', 'title': 'AffloVest Arm', 'description': 'AffloVest placed on subject at highest intensity for five (5) minutes'}, {'id': 'OG002', 'title': 'Monarch Arm', 'description': 'Monarch placed on subject at highest intensity for five (5) minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.36', 'upperLimit': '1.87'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.34', 'upperLimit': '2.47'}, {'value': '1.12', 'groupId': 'OG002', 'lowerLimit': '0.38', 'upperLimit': '2.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Patient baseline result'}, {'id': 'OG001', 'title': 'AffloVest Arm', 'description': 'AffloVest placed on subject at highest intensity for five (5) minutes'}, {'id': 'OG002', 'title': 'Monarch Arm', 'description': 'Monarch placed on subject at highest intensity for five (5) minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '7.08', 'groupId': 'OG000', 'lowerLimit': '4.39', 'upperLimit': '10.62'}, {'value': '7.09', 'groupId': 'OG001', 'lowerLimit': '4.38', 'upperLimit': '10.32'}, {'value': '7.68', 'groupId': 'OG002', 'lowerLimit': '4.85', 'upperLimit': '11.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques', 'unitOfMeasure': 'L/s', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Patient baseline result'}, {'id': 'OG001', 'title': 'AffloVest Arm', 'description': 'AffloVest placed on subject at highest intensity for five (5) minutes'}, {'id': 'OG002', 'title': 'Monarch Arm', 'description': 'Monarch placed on subject at highest intensity for five (5) minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.82', 'groupId': 'OG000', 'lowerLimit': '2.61', 'upperLimit': '5.45'}, {'value': '3.70', 'groupId': 'OG001', 'lowerLimit': '2.48', 'upperLimit': '5.45'}, {'value': '3.83', 'groupId': 'OG002', 'lowerLimit': '2.77', 'upperLimit': '5.04'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Patient baseline result'}, {'id': 'OG001', 'title': 'AffloVest Arm', 'description': 'AffloVest placed on subject at highest intensity for five (5) minutes'}, {'id': 'OG002', 'title': 'Monarch Arm', 'description': 'Monarch placed on subject at highest intensity for five (5) minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'groupId': 'OG000', 'lowerLimit': '2.15', 'upperLimit': '4.73'}, {'value': '3.04', 'groupId': 'OG001', 'lowerLimit': '2.03', 'upperLimit': '4.66'}, {'value': '3.09', 'groupId': 'OG002', 'lowerLimit': '2.23', 'upperLimit': '4.33'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Patient baseline result'}, {'id': 'OG001', 'title': 'AffloVest Arm', 'description': 'AffloVest placed on subject at highest intensity for five (5) minutes'}, {'id': 'OG002', 'title': 'Monarch Arm', 'description': 'Monarch placed on subject at highest intensity for five (5) minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.37', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '5.06'}, {'value': '3.08', 'groupId': 'OG001', 'lowerLimit': '1.85', 'upperLimit': '4.90'}, {'value': '3.05', 'groupId': 'OG002', 'lowerLimit': '2.24', 'upperLimit': '4.54'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques', 'unitOfMeasure': 'L/s', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AffloVest Monarch Arm', 'description': 'Devices placed on highest intensity / highest frequency\n\nInternational Biophysics AffloVest: High-frequency chest wall oscillation vest\n\nHill-Rom Monarch: High-frequency chest wall oscillation vest'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AffloVest Monarch Arm', 'description': 'Devices placed on highest intensity / highest frequency\n\nInternational Biophysics AffloVest: High-frequency chest wall oscillation vest\n\nHill-Rom Monarch: High-frequency chest wall oscillation vest'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-03', 'size': 92724, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-04T10:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2018-08-09', 'resultsFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-24', 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices', 'timeFrame': '30 minutes', 'description': 'Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques'}, {'measure': 'Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices', 'timeFrame': '30 minutes', 'description': 'Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques'}, {'measure': 'Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices', 'timeFrame': '30 minutes', 'description': 'Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques'}, {'measure': 'Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices', 'timeFrame': '30 minutes', 'description': 'Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques'}, {'measure': 'Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices', 'timeFrame': '30 minutes', 'description': 'Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis', 'Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of several products and comparing to baseline values', 'detailedDescription': 'The study will be broken into one (1) arm:\n\n• AffloVest® \\& Monarch™\n\nWithin the arm, the order of products will be randomized.\n\nBaseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be taken at the beginning, middle and end of each series of measurements with each subject, without any device on the subject. A product (AffloVest or Monarch) will be placed onto subject and turned ON to the highest frequency and intensity settings. Then the subject will be given a certain period of time to adjust and spirometry measurements will then be repeated, then the product will be removed and the subject will be allowed a recovery period, then the other product will be placed on the subject, turned ON and spirometry measurements will repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Healthy subject, ages 18 - 50\n\nExclusion Criteria:\n\n* Non-ambulatory\n* diagnosed neuromuscular disorder\n* currently using any type of oscillation vest therapy\n* diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease)\n* currently enrolled in a medical research study\n* non-English speaking\n* presence of the following active implantable devices: pacemakers, neurostimulators, infusion pumps, circulatory support devices, implantable cardioverter defibrillators (ICD's), cochlear implants\n* presence of head and/or neck injury that has not yet been stabilized\n* presence of active hemorrhage with hemodynamic instability"}, 'identificationModule': {'nctId': 'NCT03628456', 'briefTitle': 'Effect of HFCWO Vests on Spirometry Measurements', 'organization': {'class': 'INDUSTRY', 'fullName': 'International Biophysics Corporation'}, 'officialTitle': 'Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study', 'orgStudyIdInfo': {'id': '2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AffloVest Monarch Arm', 'description': 'Devices placed on highest intensity / highest frequency', 'interventionNames': ['Device: International Biophysics AffloVest', 'Device: Hill-Rom Monarch']}], 'interventions': [{'name': 'International Biophysics AffloVest', 'type': 'DEVICE', 'description': 'High-frequency chest wall oscillation vest', 'armGroupLabels': ['AffloVest Monarch Arm']}, {'name': 'Hill-Rom Monarch', 'type': 'DEVICE', 'description': 'High-frequency chest wall oscillation vest', 'armGroupLabels': ['AffloVest Monarch Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'PDS Research', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}], 'overallOfficials': [{'name': "Thomas W O'Brien, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PDS Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Biophysics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}