Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-04-02 @ 5:29 AM
Study NCT ID:
NCT01009632
Status:
COMPLETED
Last Update Posted:
2009-11-09
First Post:
2009-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Exercise for Wound Healing in the Larynx
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': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-06', 'studyFirstSubmitDate': '2009-11-05', 'studyFirstSubmitQcDate': '2009-11-06', 'lastUpdatePostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers in laryngeal secretions', 'timeFrame': 'Up to 24-hour post-baseline'}], 'secondaryOutcomes': [{'measure': 'Phonation Threshold Pressure (PTP)', 'timeFrame': 'Up to 24-hour post baseline'}, {'measure': 'Direct Magnitude Estimations of phonatory effort (DME)', 'timeFrame': 'Up to 24-hour post baseline'}, {'measure': 'Visual-perceptual ratings of the larynx', 'timeFrame': 'Up to 24-hour post baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Phonotrauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore quantitatively the hypothesis that "resonant voice," may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests.', 'detailedDescription': 'The objective is to use the following operationalized question: Does a voicing mode shown to correspond to high-amplitude, low impact vocal cord oscillations, "resonant voice," improve the amount and time-course of recovery from acute phonotrauma, compared to vocal rest or spontaneous speech, as measured with molecular assays (primarily) and with behavioral and clinical tests (secondarily)?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and females who have had voice training and feel they are able to produce loud voice safely;\n* ages 18-49;\n* generally healthy;\n* normal hearing bilaterally at 20 dB to 8,000 Hz; and\n* demonstrated ability to produce "resonant voice" during training as determined by the examiner perceptually.\n\nExclusion Criteria:\n\n* current chronic voice problems;\n* current medications that are determined to possibly influence voice (e.g. diuretics, decongestants);\n* heightened gag reflex;\n* small nasal passage;\n* deviated septum; and\n* known or suspected allergy to anesthetics.'}, 'identificationModule': {'nctId': 'NCT01009632', 'briefTitle': 'Role of Exercise for Wound Healing in the Larynx', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Role of Exercise for Wound Healing in the Larynx', 'orgStudyIdInfo': {'id': 'DC005643'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Voice rest', 'interventionNames': ['Behavioral: Voice rest']}, {'type': 'EXPERIMENTAL', 'label': 'Resonant voice exercise', 'interventionNames': ['Behavioral: Resonant voice']}, {'type': 'EXPERIMENTAL', 'label': 'Spontaneous speech', 'interventionNames': ['Behavioral: Spontaneous speech']}], 'interventions': [{'name': 'Resonant voice', 'type': 'BEHAVIORAL', 'description': '4-hr of resonant voice exercise', 'armGroupLabels': ['Resonant voice exercise']}, {'name': 'Voice rest', 'type': 'BEHAVIORAL', 'description': '4-hr of complete refrain from any voice use', 'armGroupLabels': ['Voice rest']}, {'name': 'Spontaneous speech', 'type': 'BEHAVIORAL', 'otherNames': ['4-hr of conversational (normal) voice use'], 'armGroupLabels': ['Spontaneous speech']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univesity of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Katherine Verdolini Abbott, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Katherine Verdolini Abbott', 'oldOrganization': 'University of Pittsburgh'}}}}