Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT03328702
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2017-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CPAP to Improve Swallow Function Post Total Laryngectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pcbelafsky@ucdavis.edu', 'phone': '8582053366', 'title': 'Dr. Peter Belafsky', 'organization': 'University of California, Davis'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '20 minutes (the approximate duration of the fluoroscopic swallow study).', 'description': 'There were no adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Continue Positive Airway Pressure', 'description': 'Continue Positive Airway Pressure during VFSE\n\nContinuous Positive Airway Pressure: Apex XT Fit CPAP Machine', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Pharyngeal Transit Time (With CPAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue Positive Airway Pressure', 'description': 'Continue Positive Airway Pressure during VFSE\n\nContinuous Positive Airway Pressure: Apex XT Fit CPAP Machine'}], 'classes': [{'categories': [{'measurements': [{'value': '10.18', 'spread': '8.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.01', 'pValueComment': 'Repeated measures ANOVA, N=4', 'groupDescription': 'The null hypothesis is that there is no difference in total pharyngeal transit time with the use of CPAP', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measures ANOVA', 'nonInferiorityComment': 'Repeated measures ANOVA'}], 'paramType': 'MEAN', 'timeFrame': 'During VFSE (1 day)', 'description': 'This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The total pharyngeal transit time'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continue Positive Airway Pressure', 'description': 'Continue Positive Airway Pressure during VFSE\n\nContinuous Positive Airway Pressure: Apex XT Fit CPAP Machine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Continue Positive Airway Pressure', 'description': 'Continue Positive Airway Pressure during VFSE\n\nContinuous Positive Airway Pressure: Apex XT Fit CPAP Machine'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Total Pharyngeal Transit Time @ Baseline (No CPAP)', 'classes': [{'categories': [{'measurements': [{'value': '26.88', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-20', 'size': 233766, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-16T14:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2017-10-29', 'resultsFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-16', 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Pharyngeal Transit Time (With CPAP)', 'timeFrame': 'During VFSE (1 day)', 'description': 'This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Dysphagia', 'Oropharyngeal dysphagia', 'Total Laryngectomy', 'Video Fluoroscopic Swallowing Exam (VFSE)'], 'conditions': ['Oropharyngeal Dysphagia', 'Laryngectomy; Status']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://studypages.com/s/a-study-of-continuous-positive-airway-pressure-cpap-to-improve-swallow-function-after-total-laryngectomy-784332/', 'label': 'Learn more or sign up for the study here!'}]}, 'descriptionModule': {'briefSummary': 'Investigator initiated prospective study to determine whether use of Continuous Positive Airway Pressure (CPAP) can improve the swallow function in patients who underwent total laryngectomy and are experiencing difficulty swallowing', 'detailedDescription': 'Total laryngectomy is a procedure that involves surgical removal of the larynx and separation of the digestive and airway tracts. The procedure is typically conducted for cases of laryngeal cancer and intractable aspiration. Following this procedure, patients are no longer at risk for aspiration; however some patients continue to experience difficulties in propulsion of food or drink throughout the pharynx. Previous research has demonstrated a reduction in pharyngeal contractile pressure and increased pharyngeal transit time in patients post laryngectomy. Continuous Positive Airway Pressure (CPAP) may assist bolus propulsion in these patients by increasing pressure in the direction of bolus flow. This study aims to evaluate the utility of a CPAP mask to improve pharyngeal swallow outcomes during Video Fluoroscopic Swallowing Exam (VFSE) in patients with dysphagia following total laryngectomy. This specific population could be well-suited for this application, since the digestive tract and airway are completely separate and there is no risk of the aspiration into the airway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at least 2 months after total laryngectomy\n* Undergoing Video Fluoroscopic Swallowing Examination\n\nExclusion Criteria:\n\n* Patients with 100% neopharyngeal stenosis\n* Patients with active cancer within 2 months of the study\n* Patients with pharyngocutaneous fistula\n* Vulnerable population: Adults unable to consent, Pregnant women, and Prisoners'}, 'identificationModule': {'nctId': 'NCT03328702', 'briefTitle': 'CPAP to Improve Swallow Function Post Total Laryngectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy', 'orgStudyIdInfo': {'id': '908521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continue Positive Airway Pressure', 'description': 'Continue Positive Airway Pressure during VFSE', 'interventionNames': ['Device: Continuous Positive Airway Pressure']}], 'interventions': [{'name': 'Continuous Positive Airway Pressure', 'type': 'DEVICE', 'description': 'Apex XT Fit CPAP Machine', 'armGroupLabels': ['Continue Positive Airway Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}