Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT01107795
Status:
TERMINATED
Last Update Posted:
2020-01-06
First Post:
2010-04-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kwithrow@uabmc.edu', 'phone': '(205) 801-7874', 'title': 'Dr. Kirk Withrow', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Transoral BOT', 'description': 'Participants who received transoral base of tongue surgery as treatment for OASHS.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 4, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'postoperative hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'laryngeal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Apnea Hypopnea Index (AHI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transoral BOT', 'description': 'Participants who received transoral base of tongue surgery as treatment for OASHS.'}], 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Improvement in Apnea Hypopnea Index (AHI) score, as measured by a polysomnogram sleep study. The AHI score is the number of apnea events per hour, with a lower score indicating mild sleep apnea and a higher score indicating severe sleep apnea. An improved AHI score would be a lower score at 6 months than at 3 months and baseline.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant attrition rate was very high; no data were collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transoral BOT', 'description': 'Participants who received transoral base of tongue surgery as treatment for OASHS.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transoral BOT', 'description': 'Participants who received transoral base of tongue surgery as treatment for OASHS.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', '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': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '31', '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': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Participants Stratified by Apnea Hypopnea Index (AHI) score', 'classes': [{'title': 'Mild apnea (AHI score of 0 to 14.99)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Moderate apnea (AHI score of 15 to 29.99)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Severe apnea (AHI score of 30 or higher)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'no recorded AHI score available', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The Apnea Hypopnea Index (AHI) score is the number of apnea and hypopnea events per hour, as recorded during a sleep study. A score from 0 to 14.99 denotes mild sleep apnea; 15 to 29.99 is moderate sleep apnea, while a score of 30 and above is considered severe sleep apnea.', 'unitOfMeasure': 'participants', 'populationDescription': 'Participants with no recorded AHI score were considered eligible for surgery based on the RDI (Respiratory Disturbance Index) score. There is no way to convert an RDI score to an AHI score without access to the original sleep study data, as RDI takes into account all respiratory-effort related arousals.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2012-01-26', 'size': 533742, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-20T13:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'Participant attrition before final follow-up visit was greater than anticipated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2010-04-08', 'resultsFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2010-04-20', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-17', 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Apnea Hypopnea Index (AHI) Score', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Improvement in Apnea Hypopnea Index (AHI) score, as measured by a polysomnogram sleep study. The AHI score is the number of apnea events per hour, with a lower score indicating mild sleep apnea and a higher score indicating severe sleep apnea. An improved AHI score would be a lower score at 6 months than at 3 months and baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study only and does not provide for evaluations or treatment of OSAHS.', 'detailedDescription': 'Obstructive sleep apnea hypopnea syndrome (OSAHS) is a major public health problem, and studies suggest that the incidence of OSAHS may be even higher than estimated. Transoral base of tongue resections are commonly preformed to improve symptoms in OSAHS, but among surgeons there is not yet consensus as to the best tongue base operation. The difficulty in treating the tongue base is illustrated by the abundance of available procedures - including genioglossus advancement, hyoid advancement, tongue base suspension, radiofrequency treatment, transoral midline glossesctomy, submucosal coblation-assisted tongue base resection and recently; transoral robotic-assisted surgery (TORS) for base of tongue (BOT) resection. We will evaluate TORS BOT resection for use in OSAHS by assessing pre- and post-operative OSAHS scores and comparing them to historical data for alternative BOT operations.\n\nThough routine, BOT resection may result in significant post-operative pain leading to dysphagia. In certain patients, major complications such as aspiration pneumonia, malnutrition and dehydration can occur as a result. Thus, reducing post-operative dysphagia is critical to improving patient outcomes and limiting complication-associated hospital admissions. Several studies have addressed the management of post-operative dysphagia, but none have evaluated TORS BOT resections in OSAHS. Additionally, TORS BOT resections for malignant neoplasms have been previously shownto be safe and feasible. An outcome analysis of TORS BOT resections for OSAHS may therefore yield recommendations for reducing patient morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who choose to undergo transoral robotic assisted tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any patient with documented OSAHS who is scheduled for tongue base resection at UAB\n2. Age \\> 18\n3. Patients must sign informed consent\n\nExclusion Criteria:\n\n1. Psychological condition that renders the patient unable to understand the informed consent\n2. Any situation or condition that will interfere with adherence to study activities'}, 'identificationModule': {'nctId': 'NCT01107795', 'briefTitle': 'Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Prospective Study to Evaluate Outcomes From Transoral Base of Tongue Resection for Obstructive Sleep Apnea Hypopnea Syndrome', 'orgStudyIdInfo': {'id': 'F091104002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transoral Robotic Surgery', 'type': 'PROCEDURE', 'description': 'Base of tongue resection with transoral robotic-assisted surgery (TORS).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Kirk Withrow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kirk P. Withrow, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}