Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-04 @ 5:56 AM
Study NCT ID:
NCT02286960
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2014-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Milan.Amin@nyulangone.org', 'phone': '646-754-1206', 'title': 'Milan Amin', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Steroid', 'description': 'Prednizone pills. 4 day course 2 x 20mg per day.\n\nSteroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Lactose Pills. 4 day course 2 x 20mg per day.\n\nLactose Pills: 4 day course 2 x 20mg per da', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Prednizone pills. 4 day course 2 x 20mg per day.\n\nSteroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Lactose Pills. 4 day course 2 x 20mg per day.\n\nLactose Pills: 4 day course 2 x 20mg per da'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-treatment/baseline to 2 months', 'description': 'Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Lesion Size From Baseline to 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Prednizone pills. 4 day course 2 x 20mg per day.\n\nSteroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Lactose Pills. 4 day course 2 x 20mg per day.\n\nLactose Pills: 4 day course 2 x 20mg per da'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4694', 'spread': '0.5494', 'groupId': 'OG000'}, {'value': '0.2788', 'spread': '0.3026', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-treatment/baseline to 2 months', 'description': 'Still images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Prednizone pills. 4 day course 2 x 20mg per day.\n\nSteroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Lactose Pills. 4 day course 2 x 20mg per day.\n\nLactose Pills: 4 day course 2 x 20mg per da'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000', 'lowerLimit': '-.2', 'upperLimit': '.9'}, {'value': '0.40', 'groupId': 'OG001', 'lowerLimit': '.15', 'upperLimit': '.95'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment/baseline to following treatment/2 months', 'description': 'A change in VHI scores from pre-treatment to following treatment.\n\nScores can range from 0-120:\n\n0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Prednizone pills. 4 day course 2 x 20mg per day.\n\nSteroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Lactose Pills. 4 day course 2 x 20mg per day.\n\nLactose Pills: 4 day course 2 x 20mg per da'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Steroid', 'description': 'Prednizone pills. 4 day course 2 x 20mg per day.\n\nSteroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Lactose Pills. 4 day course 2 x 20mg per day.\n\nLactose Pills: 4 day course 2 x 20mg per da'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Steroid', 'description': 'Prednizone pills. 4 day course 2 x 20mg per day.\n\nSteroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Lactose Pills. 4 day course 2 x 20mg per day.\n\nLactose Pills: 4 day course 2 x 20mg per da'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 6 patients were lost to follow up.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-06-19', 'size': 2002177, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-11T12:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2014-11-06', 'resultsFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-27', 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months', 'timeFrame': 'pre-treatment/baseline to 2 months', 'description': 'Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable.'}], 'secondaryOutcomes': [{'measure': 'Change in Lesion Size From Baseline to 2 Months', 'timeFrame': 'pre-treatment/baseline to 2 months', 'description': 'Still images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold.'}, {'measure': 'Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.', 'timeFrame': 'Pre-treatment/baseline to following treatment/2 months', 'description': 'A change in VHI scores from pre-treatment to following treatment.\n\nScores can range from 0-120:\n\n0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen'}, {'measure': 'Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.', 'timeFrame': '2 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphonia']}, 'descriptionModule': {'briefSummary': 'Despite the considerable use of oral steroids in the regular management of benign vocal fold lesions there is little evidence base in the literature. This study will investigate the efficacy of oral steroids for the treatment of vocal fold lesions in a controlled manner. The specific aim of this study is to determine the effectiveness of of a short course of oral steroids prior to behavioral voice therapy in patients with benign, phonotraumatic vocal fold lesions. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.', 'detailedDescription': 'The study will investigate the potential added advantage of the use of steroids in patients undergoing voice therapy. Enrolled subjects will be randomized using a random numbers table to either receive oral steroids or no steroids prior to the initiation of voice therapy. The therapist and individuals involved in the collection and analysis of data will be blinded as to whether the subject received drug. Prior to initiation of therapy subjects will be asked to return for an interval evaluation during which they undergo videostroboscopy and voice evaluation. Subjects will enter then the voice therapy phase . After an initial evaluation to determine the best mode of therapy they will receive a behavioral voice therapy course, which includes a range of behavioral modifications and motor learning techniques, along with lifestyle measures. In all these phases acoustic and aerodynamic measurements will be collected as well as audio-visual material from the videostroboscopic exams. The measurements that will be collected in all these phases are the Voice Handicap Index (VHI)-10 , the noise to harmonic ratio H/N, the fundamental frequency Fo, The transglottic airflow and subglottic pressure. The investigators hypothesize that oral steroids will lead to a reduction in lesion size, which will substantially aid in the delivery and incorporation of voice therapy techniques, contributing to the improvement of overall laryngeal biomechanics and providing an ideal starting point for behavioral voice therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 males and females\n* Presence of phonotraumatic lesion deemed to be etiologic for the complaint of dysphonia\n* Voice therapy deemed to be the primary (or at least initial) treatment to address the dysphonia.\n* Willingness to be an active participant in voice therapy.\n\nExclusion Criteria:\n\n* Use of any glucocorticoids (oral, inhaled, or intravenous) within 3 months of the initial evaluation\n* Known allergy or hypersensitivity to oral steroids\n* Active infection\n* Diabetes Mellitus\n* Prior history of radiation to the neck\n* Recent myocardial infarction\n* Recent gastrointestinal surgery with bowel anastamosis (3 months)\n* Active peptic ulcer\n* Pregnancy\n* Severe depression or history of psycosis\n* History of recent laryngeal surgery (within 12 months)'}, 'identificationModule': {'nctId': 'NCT02286960', 'acronym': 'AAO', 'briefTitle': 'Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes', 'orgStudyIdInfo': {'id': '13-00096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid', 'description': 'Prednizone pills. 4 day course 2 x 20mg per day.', 'interventionNames': ['Drug: Steroid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Lactose Pills. 4 day course 2 x 20mg per day.', 'interventionNames': ['Dietary Supplement: Lactose Pills']}], 'interventions': [{'name': 'Steroid', 'type': 'DRUG', 'otherNames': ['Prednizone'], 'description': 'A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.', 'armGroupLabels': ['Steroid']}, {'name': 'Lactose Pills', 'type': 'DIETARY_SUPPLEMENT', 'description': '4 day course 2 x 20mg per da', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Milan Amin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}