Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-17 @ 12:58 AM
Study NCT ID:
NCT04114604
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2019-09-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tri-swallowinglab@uhn.ca', 'phone': '416 597 3422', 'title': 'Director, Swallowing Rehabilitation Research Laboratory', 'phoneExt': '7802', 'organization': 'KITE Research Institute - Toronto Rehabilitation Institute, University Health Network'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week following data collection', 'eventGroups': [{'id': 'EG000', 'title': 'Spinal Cord Injury', 'description': 'Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Displaying Unsafe Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Thin Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder and water.'}, {'id': 'OG001', 'title': 'Slightly Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG002', 'title': 'Mildly Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG003', 'title': 'Moderately Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of moderately thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG004', 'title': 'Extremely Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of extremely thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (single timepoint only)', 'description': 'The Penetration-Aspiration Scale is an 8-point categorical scale that is used to characterize swallowing safety for each bolus based on the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels \\> 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (\\< 3 vs \\>/= 3). We report the frequency (count) of participants showing unsafe swallowing (i.e., scores \\> 2) by bolus consistency.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).'}, {'type': 'PRIMARY', 'title': 'Number of Participants Displaying Post-swallow Inhalation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Thin Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder and water.'}, {'id': 'OG001', 'title': 'Slightly Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG002', 'title': 'Mildly Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG003', 'title': 'Moderately Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of moderately thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG004', 'title': 'Extremely Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of extremely thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (single timepoint only)', 'description': 'Healthy swallowing typically occurs partway through an outward breath, such that the direction of breathing both before and after the swallow is exhalation. Whenever a swallow is followed immediately by inhalation, this is considered abnormal and a risk for food or liquid material to be sucked into the airway. We measured the direction of breathing before and after swallows via nasal cannula using the airflow module of the KayPentax Digital Swallow Workstation Swallowing Signals Lab. We report the frequency (percentage) of participants displaying at least one swallow showing post-swallow inhalation by consistency.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A sample of 10 adults was enrolled. Due to signal quality issues, data were missing for one participant across all consistencies and for an additional participant on moderately thick liquid barium.'}, {'type': 'PRIMARY', 'title': 'Duration of the Respiratory Pause Seen in Swallowing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Thin Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of thin liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder and water.'}, {'id': 'OG001', 'title': 'Slightly Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of slightly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG002', 'title': 'Mildly Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of mildly thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG003', 'title': 'Moderately Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of moderately thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}, {'id': 'OG004', 'title': 'Extremely Thick Liquid Barium', 'description': 'Participants were asked to take a series of 3 comfortable sips of extremely thick liquid barium prepared in 20% w/v concentration using Bracco E-Z-Paque powder, water and Nestle Resource ThickenUp Clear thickener.'}], 'classes': [{'categories': [{'measurements': [{'value': '901', 'spread': '485', 'groupId': 'OG000'}, {'value': '996', 'spread': '573', 'groupId': 'OG001'}, {'value': '867', 'spread': '455', 'groupId': 'OG002'}, {'value': '721', 'spread': '275', 'groupId': 'OG003'}, {'value': '815', 'spread': '541', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (single timepoint only)', 'description': 'Healthy swallowing typically occurs partway through an outward (exhalatory) breath, and involves a pause in breathing. The duration of this respiratory pause was measured in milliseconds for each swallow based on the continuous airflow waveform collected via nasal cannula using the airflow module of the KayPentax Digital Swallow Workstation Swallowing Signals Lab. We report means and standard deviations for respiratory pause duration by consistency. Shorter respiratory pause durations reflect inadequate airway protection.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A sample of 10 adults was enrolled. Due to signal quality issues, data were missing for one participant across all consistencies and for an additional participant on moderately thick liquid barium.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spinal Cord Injury', 'description': 'Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).'}], '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': 'Spinal Cord Injury', 'description': 'Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-23', 'size': 2980841, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-15T10:53', 'hasProtocol': True}, {'date': '2017-03-28', 'size': 217863, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-15T10:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2019-09-27', 'resultsFirstSubmitDate': '2022-06-15', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-17', 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Displaying Unsafe Swallowing', 'timeFrame': 'Baseline (single timepoint only)', 'description': 'The Penetration-Aspiration Scale is an 8-point categorical scale that is used to characterize swallowing safety for each bolus based on the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels \\> 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (\\< 3 vs \\>/= 3). We report the frequency (count) of participants showing unsafe swallowing (i.e., scores \\> 2) by bolus consistency.'}, {'measure': 'Number of Participants Displaying Post-swallow Inhalation', 'timeFrame': 'Baseline (single timepoint only)', 'description': 'Healthy swallowing typically occurs partway through an outward breath, such that the direction of breathing both before and after the swallow is exhalation. Whenever a swallow is followed immediately by inhalation, this is considered abnormal and a risk for food or liquid material to be sucked into the airway. We measured the direction of breathing before and after swallows via nasal cannula using the airflow module of the KayPentax Digital Swallow Workstation Swallowing Signals Lab. We report the frequency (percentage) of participants displaying at least one swallow showing post-swallow inhalation by consistency.'}, {'measure': 'Duration of the Respiratory Pause Seen in Swallowing', 'timeFrame': 'Baseline (single timepoint only)', 'description': 'Healthy swallowing typically occurs partway through an outward (exhalatory) breath, and involves a pause in breathing. The duration of this respiratory pause was measured in milliseconds for each swallow based on the continuous airflow waveform collected via nasal cannula using the airflow module of the KayPentax Digital Swallow Workstation Swallowing Signals Lab. We report means and standard deviations for respiratory pause duration by consistency. Shorter respiratory pause durations reflect inadequate airway protection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries', 'Deglutition Disorders']}, 'descriptionModule': {'briefSummary': 'This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing.The focus of this study is to evaluate the flow of liquids of varying consistency in the spinal disorder population.', 'detailedDescription': 'Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). However, the field lacks a clear understanding of how liquids of different consistencies behave during swallowing. In order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx. This study explores this question in individuals with spinal cord injury. Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, mildly thick, moderately thick and extremely thick). Swallowing will be observed under videofluoroscopy. Simultaneous measures of airflow via nasal cannula will be used to study respiratory-swallow coordination in this study sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will recruit participants from the inpatient SCI program at the Toronto Rehabilitation Institute Lyndhurst Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSpinal cord injury at the cervical or thoracic level (T6 or higher)\n\nExclusion Criteria:\n\n* Prior history of swallowing, motor speech, gastro-esophageal difficulties, chronic sinusitis or taste disturbance.\n* Neurological difficulties unrelated to spinal disorder (e.g. Stroke, Parkinson disease, etc).\n* Cognitive communication difficulties that may hinder ability to participate.\n* Current use of mechanical ventilation\n* External instrumentation around the head/neck that would obstruct the field of view during the videofluoroscopy exam (e.g. cervical collar).\n* Type 1 Diabetes (due to the requirement to swallow stimuli containing starch based thickeners, which carry a significant carbohydrate load).\n* Known allergies to latex, food coloring or dental glue (due to the probability that these items will come into contact with the oral mucosa during data collection).\n* Children and pregnant women (due to the use of radiation during the videofluoroscopic examination).'}, 'identificationModule': {'nctId': 'NCT04114604', 'briefTitle': 'Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study', 'orgStudyIdInfo': {'id': '16-6310'}, 'secondaryIdInfos': [{'id': '5R01DC011020', 'link': 'https://reporter.nih.gov/quickSearch/5R01DC011020', 'type': 'NIH'}, {'id': 'CAPCR 16-6310', 'type': 'OTHER', 'domain': 'UHN Research Ethics Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal Cord Injury', 'description': 'Adults who have sustained a spinal cord injury at the cervical or upper thoracic level (T6 or higher).'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G 3V9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Rehabilitation Institute - Lyndhurst Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Catriona Steele', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KITE - Toronto Rehabilitation Institute, University Health Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not planned at this time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}