Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-03 @ 6:34 AM
Study NCT ID:
NCT02788435
Status:
UNKNOWN
Last Update Posted:
2018-08-15
First Post:
2016-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Voice Rest on Voice Outcomes Following Phonosurgery
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Voice Handicap Index (VHI)-10', 'timeFrame': '4 weeks post-operative'}, {'measure': 'Voice Handicap Index (VHI)-10', 'timeFrame': '12 weeks post-operative'}], 'secondaryOutcomes': [{'measure': 'Frequency perturbation (jitter)', 'timeFrame': '4 weeks post-operative'}, {'measure': 'Frequency perturbation (jitter)', 'timeFrame': '12 weeks post-operative'}, {'measure': 'Amplitude perturbation (shimmer)', 'timeFrame': '4 weeks post-operative'}, {'measure': 'Amplitude perturbation (shimmer)', 'timeFrame': '12 weeks post-operative'}, {'measure': 'Fundamental frequency', 'timeFrame': '4 weeks post-operative'}, {'measure': 'Fundamental frequency', 'timeFrame': '12 weeks post-operative'}, {'measure': 'Maximum phonation time', 'timeFrame': '4 weeks post-operative'}, {'measure': 'Maximum phonation time', 'timeFrame': '12 weeks post-operative'}, {'measure': 'Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale', 'timeFrame': '4 weeks post-operative'}, {'measure': 'Perceptual grading of voice using the Grade, Roughness, Breathiness, Asthenia, Strain, Instability (GRBASI)-scale', 'timeFrame': '12 weeks post-operative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Unilateral Vocal Cord Lesions']}, 'referencesModule': {'references': [{'pmid': '31498467', 'type': 'DERIVED', 'citation': 'Dhaliwal SS, Doyle PC, Failla S, Hawkins S, Fung K. Role of voice rest following laser resection of vocal fold lesions: A randomized controlled trial. Laryngoscope. 2020 Jul;130(7):1750-1755. doi: 10.1002/lary.28287. Epub 2019 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing vocal cord surgery (phonosurgery) are often prescribed voice rest postoperatively. However, no clinical trials have ever been conducted to ascertain the efficacy of using voice rest and its impact on functional voice outcomes. The purpose of this randomized-clinical trial is to determine if the prescription of voice rest has an impact on voice outcomes following phonosurgery.', 'detailedDescription': 'The study will seek to determine if a 7-day period of absolute voice rest alters voice-related quality of life following phonosurgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years\n* Unilateral vocal cord lesion\n* Consented for phonosurgery\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Bilateral vocal cord lesions\n* Prior vocal cord surgery'}, 'identificationModule': {'nctId': 'NCT02788435', 'briefTitle': 'The Role of Voice Rest on Voice Outcomes Following Phonosurgery', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'The Role of Voice Rest on Voice Outcomes Following Phonosurgery: A Randomized-Controlled Trial', 'orgStudyIdInfo': {'id': '107893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in the control arm will undergo a graduated prescription of voice use immediately following surgery.'}, {'type': 'EXPERIMENTAL', 'label': 'Absolute Voice Rest', 'description': 'Patients in the experimental arm will undergo 7 days of absolute voice rest following surgery.', 'interventionNames': ['Behavioral: Absolute Voice Rest']}], 'interventions': [{'name': 'Absolute Voice Rest', 'type': 'BEHAVIORAL', 'description': 'Patients will be instructed to not use their voice and minimize any voice-use activities such as coughing or throat-clearing for a period of 7 days following surgery.', 'armGroupLabels': ['Absolute Voice Rest']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kevin Fung, MD, FRCSC', 'role': 'CONTACT'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Kevin Fung, MD, FRCSC', 'role': 'CONTACT', 'email': 'Kevin.Fung@lhsc.on.ca'}], 'overallOfficials': [{'name': 'Kevin Fung, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otolaryngology - Head & Neck Surgery, Western University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}