Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-28 @ 9:13 AM
Study NCT ID:
NCT04537650
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Swallowing Impairment After COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'catriona.steele@uhn.ca', 'phone': '14165973422', 'title': 'Catriona M. Steele, PhD', 'phoneExt': '7802', 'organization': 'KITE Research Institute - University Health Network'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Within 1 week of data collection', 'eventGroups': [{'id': 'EG000', 'title': 'COVID-19 Ventilated', 'description': 'This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This group of participants did not require mechanical ventilation during their COVID-19 infection', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Impaired Swallowing Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Ventilated', 'description': 'This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection'}, {'id': 'OG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This group of participants did not require mechanical ventilation during their COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21', 'ciLowerLimit': '1.8', 'ciUpperLimit': '243.24', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants demonstrating airway invasion on thin liquids, defined as Penetration-Aspiration Scale score of 3 and higher (Rosenbek et al., 1996). Higher scores indicate worse function.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Impaired Swallowing Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Ventilated', 'description': 'This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection'}, {'id': 'OG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This group of participants did not require mechanical ventilation during their COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45', 'ciLowerLimit': '4.15', 'ciUpperLimit': '487.5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants demonstrating pharyngeal residue on extremely thick liquids measured to fill more than 1.5% of an anatomical reference scalar \\[%(C2-4)squared\\] (Steele et al., 2019)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Ventilated', 'description': 'This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection'}, {'id': 'OG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This group of participants did not require mechanical ventilation during their COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants displaying prolonged time to airway closure (i.e. Laryngeal Vestibule Closure) on thin liquids, defined as values falling above the healthy reference 75th percentile (Steele et al., 2023)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Short Laryngeal Vestibule Closure Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Ventilated', 'description': 'This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection'}, {'id': 'OG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This group of participants did not require mechanical ventilation during their COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants displaying short airway closure (i.e. laryngeal vestibule closure) on thin liquids, defined as a duration below the healthy reference 25th percentile (Steele et al., 2023)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Poor Pharyngeal Constriction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Ventilated', 'description': 'This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection'}, {'id': 'OG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This group of participants did not require mechanical ventilation during their COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants displaying poor pharyngeal constriction on extremely thick liquids, defined as pharyngeal area above the 75th percentile healthy reference value on the frame of maximum constriction (Steele et al., 2023)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Impaired LVC Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Ventilated', 'description': 'This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection'}, {'id': 'OG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This group of participants did not require mechanical ventilation during their COVID-19 infection'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Videofluoroscopy (single timepoint only)', 'description': 'Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COVID-19 Ventilated', 'description': 'This group of participants were hospitalized and require ICU care with mechanical ventilation during their COVID-19 infection'}, {'id': 'FG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This group of participants did not require mechanical ventilation during their COVID-19 infection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'COVID-19 Ventilated', 'description': 'This was a group of Community-Dwelling adults who had a history of COVID-19 infection prior to October, 2021 and who were hospitalized and required ICU care with mechanical ventilation during their COVID-19 infection'}, {'id': 'BG001', 'title': 'COVID-19 Non-ventilated', 'description': 'This was a group of Community-Dwelling adults who had a history of COVID-19 infection prior to October, 2021 but who did not require mechanical ventilation during their COVID-19 infection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '79'}, {'value': '44', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '78'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Taste or Smell Impairment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'YES (Taste/Smell impairment)', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'NO (No Taste/Smell impairment)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of Participants reporting persisting taste or smell impairment at the time of data collection', 'unitOfMeasure': 'Participants'}, {'title': 'SSQ', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '303'}, {'value': '232', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '422'}, {'value': '158', 'groupId': 'BG002', 'lowerLimit': '56', 'upperLimit': '396'}]}]}], 'paramType': 'MEDIAN', 'description': 'Score on the Sydney Swallow Questionnaire, a patient-reported dysphagia severity measure. Minimum possible score is 0. Maximum possible score is 1700. Scores \\> 234 are considered impaired. Higher scores indicate greater impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.'}, {'title': 'Time since diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '14'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '17'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'description': 'Time (in months) since COVID-19 diagnosis at the point of data collection', 'unitOfMeasure': 'Months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Tongue Weakness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants displaying tongue weakness, defined as a 1-repetition-maximum anterior isometric pressure measure of \\< 40 kPa taken across 3 repeated maximum anterior isometric pressure measurements using the Iowa Oral Performance Instrument.', 'unitOfMeasure': 'Participants'}, {'title': 'Reduced peak cough flow', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Reduced voluntary peak cough expiratory flow, defined as a peak cough flow measure \\< 270 l/s, measured using a mini-Wright analog peak-cough flow meter.', 'unitOfMeasure': 'Participants'}, {'title': 'Fail water swallow screen (3 sips)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants displaying overt signs of potential aspiration (coughs, throat clear, change of voice quality) on a water swallow screening test involving a series of 3 discrete comfortable sips of water.', 'unitOfMeasure': 'Participants'}, {'title': 'Fail water swallow screen (90cc)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'umber of participants displaying overt signs of potential aspiration (coughs, throat clear, change of voice quality, or failure to complete task) on a water swallow screening test involving continuous drinking of 90cc of water.', 'unitOfMeasure': 'Participants'}, {'title': 'SSQ Impaired', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants reporting self-perceived swallowing impairment at baseline defined as a score on the Sydney Swallow Questionnaire \\> 234.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Sydney Swallow Questionnare were missing for 12 participants in the non-ventilated and 2 participants in the ventilated group who reported no swallowing difficulties, and therefore did not complete the full questionnaire.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-16', 'size': 756319, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-07T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2020-09-01', 'resultsFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-05', 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Impaired Swallowing Safety', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants demonstrating airway invasion on thin liquids, defined as Penetration-Aspiration Scale score of 3 and higher (Rosenbek et al., 1996). Higher scores indicate worse function.'}, {'measure': 'Number of Participants With Impaired Swallowing Efficiency', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants demonstrating pharyngeal residue on extremely thick liquids measured to fill more than 1.5% of an anatomical reference scalar \\[%(C2-4)squared\\] (Steele et al., 2019)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Prolonged Time-to-Laryngeal-Vestibule-Closure', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants displaying prolonged time to airway closure (i.e. Laryngeal Vestibule Closure) on thin liquids, defined as values falling above the healthy reference 75th percentile (Steele et al., 2023)'}, {'measure': 'Number of Participants With Short Laryngeal Vestibule Closure Duration', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants displaying short airway closure (i.e. laryngeal vestibule closure) on thin liquids, defined as a duration below the healthy reference 25th percentile (Steele et al., 2023)'}, {'measure': 'Number of Participants With Poor Pharyngeal Constriction', 'timeFrame': 'Videofluoroscopy session (single timepoint only)', 'description': 'Frequency of participants displaying poor pharyngeal constriction on extremely thick liquids, defined as pharyngeal area above the 75th percentile healthy reference value on the frame of maximum constriction (Steele et al., 2023)'}, {'measure': 'Number of Participants With Impaired LVC Integrity', 'timeFrame': 'Videofluoroscopy (single timepoint only)', 'description': 'Number of participants displaying incomplete laryngeal vestibule closure on thin liquids.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Swallowing'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '31021676', 'type': 'BACKGROUND', 'citation': 'Steele CM, Peladeau-Pigeon M, Barbon CAE, Guida BT, Namasivayam-MacDonald AM, Nascimento WV, Smaoui S, Tapson MS, Valenzano TJ, Waito AA, Wolkin TS. Reference Values for Healthy Swallowing Across the Range From Thin to Extremely Thick Liquids. J Speech Lang Hear Res. 2019 May 21;62(5):1338-1363. doi: 10.1044/2019_JSLHR-S-18-0448.'}, {'pmid': '8721066', 'type': 'BACKGROUND', 'citation': 'Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.'}, {'pmid': '37669617', 'type': 'BACKGROUND', 'citation': 'Steele CM, Bayley MT, Bohn MK, Higgins V, Peladeau-Pigeon M, Kulasingam V. Reference Values for Videofluoroscopic Measures of Swallowing: An Update. J Speech Lang Hear Res. 2023 Oct 4;66(10):3804-3824. doi: 10.1044/2023_JSLHR-23-00246. Epub 2023 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study, in which people recovering from COVID-19 infection will attend an outpatient clinic for a comprehensive swallowing assessment. The assessment will include a videofluoroscopy, measurement of respiratory-swallow coordination using a digital stethoscope, measures of tongue and cough strength and patient reported measures that will help us to understand the presence and impact of swallowing impairment (dysphagia) in this population.', 'detailedDescription': "The recent spread of COVID-19 has led to an international pandemic, with \\>3 million confirmed cases to date worldwide, of which 1 million confirmed cases and \\>50,000 deaths have been reported in the USA. Infected individuals commonly experience severe respiratory difficulties and pneumonia, leading to hospital admission and the need for intensive care and mechanical ventilation. Emerging evidence suggests that impaired taste and smell may be early markers of the disease, and that in severe cases, there may be neurological damage in in the medulla, an important brainstem control site for both respiration and swallowing. Given the overlapping neuroanatomical regulation of breathing and swallowing, the investigators hypothesize that dysphagia (swallowing impairment) will be common in People recovering from COVID-19 (PrC-19) and associated with poorer outcomes.\n\nThe investigators will offer comprehensive swallowing assessments to PrC-19 after initial recovery and a confirmed negative test for continuing COVID-19 infection. Study sites will be located in the Toronto area (PI Steele); the Hamilton-Niagara region to the west of Toronto (Co-I Namasivayam-MacDonald) and in Gainesville, Florida (Co-I Plowman). The assessments will include the collection of case history information, videofluoroscopy (i.e., a dynamic swallowing x-ray), use of a digital stethoscope to measure respiratory-swallow coordination, measures of other risk factors for dysphagia (e.g. bulbar muscle strength) and patient-reported outcomes. Detailed analyses of the videofluoroscopy swallowing studies (i.e. dynamic x-rays) will identify specific measures of swallowing that fall outside the range of normal variation based on comparison to healthy reference values established through the PI's NIH-funded research program exploring swallowing physiology on liquids of different consistencies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals recovering from COVID-19 infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People who tested positive or received a presumed positive diagnosis of COVID-19 infection not earlier than March 1, 2020 and who are at least 2 weeks post positive diagnosis and the initiation of medical management of COVID-19 infection\n* Adequate comprehension of English to understand the consent form and follow study instructions\n\nExclusion Criteria:\n\n* Age under 18 years old\n* Current pregnancy'}, 'identificationModule': {'nctId': 'NCT04537650', 'briefTitle': 'Swallowing Impairment After COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19', 'orgStudyIdInfo': {'id': 'CAPCR 20-5477'}, 'secondaryIdInfos': [{'id': '3R01DC011020-08S1', 'link': 'https://reporter.nih.gov/quickSearch/3R01DC011020-08S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 Ventilated', 'description': 'Participants who were diagnosed with COVID-19 prior to October, 2021 who required hospitalization in an ICU with mechanical ventilation during their illness.', 'interventionNames': ['Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)']}, {'label': 'COVID-19 Non-Ventilated', 'description': 'Participants who were diagnosed with COVID-19 prior to October, 2021 who did not require mechanical ventilation during their illness.', 'interventionNames': ['Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS)']}], 'interventions': [{'name': 'Videofluoroscopic Swallowing Study (VFSS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'A standardized dynamic radiographic examination of oropharyngeal swallowing', 'armGroupLabels': ['COVID-19 Non-Ventilated', 'COVID-19 Ventilated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610-3006', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Catriona M Steele, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}, {'name': 'McMaster University', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}