Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT04766658
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2021-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Effects of Gargle Phonation in Voice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}], 'ancestors': [{'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'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-02-19', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rating of Effort Baseline', 'timeFrame': 'Baseline', 'description': 'Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.'}, {'measure': 'Rating of Effort Post Swallow', 'timeFrame': 'After water swallow intervention, approximately 5 minutes', 'description': 'Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.'}, {'measure': 'Rating of Effort Post Gargle', 'timeFrame': 'After gargle phonation intervention, approximately 5 minutes', 'description': 'Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Voice Disorders', 'Muscle Tension Dysphonia', 'Speech Therapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess subjects with muscle tension dysphonia for perceived effort and acoustic effects of gargle phonation compared to baseline and a sham water swallow.', 'detailedDescription': 'This study assesses perceived effort following baseline talking, water swallows and gargle phonation. In addition to perceived effort, acoustic and perceptual analyses will be conducted on the recorded voice samples using vowel sounds, the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) and Hearing in Noise Sentences (HINT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a primary or secondary muscle tension dysphonia based clinical assessment with a Mayo clinic speech language pathologist or other Mayo Clinic otolaryngology care provider in Rochester or Phoenix/Scottsdale locations.\n* Age 18 through 89.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Anyone not meeting inclusion criteria.\n* Anyone unable or unwilling to provide informed consent.\n* Anyone unable to complete questionnaires or participate in voice recording.\n* Anyone with severe neurological voice or speech disorders.\n* Moderate or severe dysphagia for thin liquids.\n* Non-English speakers (English as a second language may be included).\n* Extensive laryngeal surgery or other surgery or medical condition that may significantly alter the motor or sensory aspects of the larynx.'}, 'identificationModule': {'nctId': 'NCT04766658', 'briefTitle': 'A Study to Evaluate Effects of Gargle Phonation in Voice', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Gargle Phonation in Individuals With Muscle Tension Dysphonia', 'orgStudyIdInfo': {'id': '20-004267'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Water Swallow Intervention First', 'description': 'Subjects will complete voice recordings after water swallows and then perform voice recordings after gargle phonation.', 'interventionNames': ['Other: Water swallow']}, {'type': 'OTHER', 'label': 'Gargle Phonation Intervention First', 'description': 'Subjects will complete voice recordings after gargle phonation and then perform voice recordings after gargle phonation.', 'interventionNames': ['Other: Gargle Phonation']}], 'interventions': [{'name': 'Gargle Phonation', 'type': 'OTHER', 'description': 'Subjects will gargle water while making sound', 'armGroupLabels': ['Gargle Phonation Intervention First']}, {'name': 'Water swallow', 'type': 'OTHER', 'description': 'Subjects will hold water in their mouth for 5 seconds and swallow', 'armGroupLabels': ['Water Swallow Intervention First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Diana M Orbelo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diana M. Orbelo', 'investigatorAffiliation': 'Mayo Clinic'}}}}