Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-02 @ 2:32 PM
Study NCT ID:
NCT02634957
Status:
TERMINATED
Last Update Posted:
2020-04-15
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Due to change in available resources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-13', 'studyFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Voice Handicap Index - 10', 'timeFrame': '3 months post op'}, {'measure': 'Voice Handicap Index - 10', 'timeFrame': '1 month post op'}], 'secondaryOutcomes': [{'measure': 'Cepstral Peak Prominence (CPP)', 'timeFrame': '1 month and 3 months post op'}, {'measure': 'Average phonatory airflow in all voiced sentence', 'timeFrame': '1 month and 3 months post op'}, {'measure': 'video stroboscopy findings', 'timeFrame': '1 month and 3 months post op'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['phonomicrosurgery', 'benign vocal fold lesions', 'voice rest', 'vhi-10', 'CPP'], 'conditions': ['Benign Neoplasm of True Vocal Cords']}, 'descriptionModule': {'briefSummary': 'Absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. Unfortunately there is no standardized protocol as to how long patients should rest their voice after phonomicrosurgery. To date, there are no studies in the literature directly comparing the impact of short-term and long-term voice rest on vocal fold healing and voice outcome after phonomicrosurgery.', 'detailedDescription': 'The purpose of this study is to determine whether 3 days versus 7 days of absolute voice rest will result in different voice outcomes in patients who have undergone phonomicrosurgery for benign vocal fold lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with benign mid membranous vocal fold lesions such as the following:\n\n 1. Polyps\n 2. Cysts\n 3. Sub-epithelial fibrous mass\n2. Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.\n3. Age 18 and older\n\nExclusion Criteria:\n\nPatients with any of the following will be excluded from the study:\n\n1. Reinke's edema\n2. Active smokers\n3. Ligamentous mid membranous vocal fold lesions\n4. RRP (Recurrent Respiratory Papillomatosis)\n5. Dysplasia\n6. CIS (Carcinoma-in-situ)\n7. SCC (squamous cell carcinoma)\n8. Extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., CO2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery)\n9. Previous vocal fold surgery\n10. Systemic steroids\n11. History of systemic illness that could affect wound healing"}, 'identificationModule': {'nctId': 'NCT02634957', 'briefTitle': 'Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery', 'orgStudyIdInfo': {'id': 'PRO15120009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 day absolute voice rest', 'description': 'participants would begin initiation of voice/speaking 3 days post phonomicrosurgery for benign vocal fold lesions', 'interventionNames': ['Behavioral: absolute voice rest']}, {'type': 'EXPERIMENTAL', 'label': '7 day absolute voice rest', 'description': 'participants would begin initiation of voice/speaking 7 days post phonomicrosurgery for benign vocal fold lesions', 'interventionNames': ['Behavioral: absolute voice rest']}], 'interventions': [{'name': 'absolute voice rest', 'type': 'BEHAVIORAL', 'description': 'absolute voice rest is the complete elimination of any vocalization (no sounds, speaking or whispering)', 'armGroupLabels': ['3 day absolute voice rest', '7 day absolute voice rest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Libby Smith, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'information may be shared during and after collection for the purpose of analysis', 'ipdSharing': 'YES', 'description': 'de-identified information with outside collaborators', 'accessCriteria': 'if not part of original IRB, sharing will only occur if there is a data use agreement executed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Libby Smith DO', 'investigatorAffiliation': 'University of Pittsburgh'}}}}