Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT03762993
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2018-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'preeti@purdue.edu', 'phone': '765-494-3788', 'title': 'Preeti Sivasankar', 'organization': 'Purdue University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were monitored for adverse events from the time consent was obtained until approximately 24 hours following study completion.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Adults', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Adults Reporting Vocal Fatigue', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phonation Threshold Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adults', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises'}, {'id': 'OG001', 'title': 'Healthy Adults Reporting Vocal Fatigue', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises'}], 'classes': [{'title': 'Pre-Exertion', 'categories': [{'measurements': [{'value': '5.41', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Post-Exertion', 'categories': [{'measurements': [{'value': '6.39', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Post Restoration Strategy', 'categories': [{'measurements': [{'value': '5.63', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '5.61', 'spread': '1.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value is for the effect of time. A priori significance level set at .05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Changes in phonation threshold pressure were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.'}], 'paramType': 'MEAN', 'timeFrame': '2.5 hours', 'description': 'Minimum air pressure required to initiate and sustain vocal fold oscillation', 'unitOfMeasure': 'cmH20', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lung Volume Excursion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adults', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises'}, {'id': 'OG001', 'title': 'Healthy Adults Reporting Vocal Fatigue', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.5', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Post Exertion', 'categories': [{'measurements': [{'value': '21.6', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Post Restoration Strategy', 'categories': [{'measurements': [{'value': '18.7', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '7.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value represents effect of group. A priori threshold for significance set at .05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Changes in lung volumes were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.'}], 'paramType': 'MEAN', 'timeFrame': '2.5 hours', 'description': 'The difference between lung volume initiation and termination on connected speech', 'unitOfMeasure': '% Vital Capacity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Adults', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises'}, {'id': 'FG001', 'title': 'Healthy Adults Reporting Vocal Fatigue', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of 37 enrolled participants, 31 were assigned to study groups based on self-reported vocal fatigue level.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Adults', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises'}, {'id': 'BG001', 'title': 'Healthy Adults Reporting Vocal Fatigue', 'description': 'Participants will complete vocal rest and controlled phonation\n\nVocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '23', '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': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '30', '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': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Vocal Fatigue Index', 'classes': [{'title': 'Vocal Fatigue Index Part 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '24', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '27'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '27'}]}]}, {'title': 'Vocal Fatigue Index Part 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '3.5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '9'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Vocal Fatigue Index measures self-reported vocal fatigue symptoms. The scale is divided into three separately scored sections (two of which were used here). Possible scores range from 0 to 44 on Part 1, and 0 - 20 on part 2. Scores \\>24 on part 1, or \\>7 on part 2 are indicative of vocal fatigue.Scores below this range are considered normal.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-22', 'size': 303040, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-24T16:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Within Subject Design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2018-11-30', 'resultsFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-03', 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phonation Threshold Pressure', 'timeFrame': '2.5 hours', 'description': 'Minimum air pressure required to initiate and sustain vocal fold oscillation'}], 'secondaryOutcomes': [{'measure': 'Lung Volume Excursion', 'timeFrame': '2.5 hours', 'description': 'The difference between lung volume initiation and termination on connected speech'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. This study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. The investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* within age range\n\nExclusion Criteria:\n\n* Voice Disorders\n* Strong gag reflex\n* Craniofacial disorders\n* Cognitive Impairments\n* Head and Neck Cancer\n* Hearing Difficulties\n* Dentition problems that prevent an oral scope being placed in mouth'}, 'identificationModule': {'nctId': 'NCT03762993', 'briefTitle': 'Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Vocal Restoration Programs After Acute Vocal Exertion', 'orgStudyIdInfo': {'id': 'Vocal restoration programs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Adults', 'description': 'Participants will complete vocal rest and controlled phonation', 'interventionNames': ['Behavioral: Vocal rest and Controlled Phonation']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Adults reporting Vocal Fatigue', 'description': 'Participants will complete vocal rest and controlled phonation', 'interventionNames': ['Behavioral: Vocal rest and Controlled Phonation']}], 'interventions': [{'name': 'Vocal rest and Controlled Phonation', 'type': 'BEHAVIORAL', 'description': 'Voice rest and semi occluded vocal tract voice exercises', 'armGroupLabels': ['Healthy Adults', 'Healthy Adults reporting Vocal Fatigue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47906', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Preeti Sivasankar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Preeti M. Sivasankar', 'investigatorAffiliation': 'Purdue University'}}}}