Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-28 @ 11:57 AM
Study NCT ID:
NCT05542550
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2022-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voice Rest and Injection Laryngoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014826', 'term': 'Vocal Cord Paralysis'}], 'ancestors': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D020421', 'term': 'Vagus Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only patient is aware of treatment group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized to one of two arms: no voice rest following injection and 48 hours voice rest following injection'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-12', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-perceived voice improvement', 'timeFrame': '2 weeks', 'description': 'Voice Handicap Index - 10. Scale range 0-40. Lower score designates lower voice impairment'}], 'secondaryOutcomes': [{'measure': 'GRBAS- Grade, Roughness, Breathiness, Asthenia, Strain', 'timeFrame': '2 weeks', 'description': 'Clinician-perceived improvement in voice. Range is 0-15. Lower score indicates lower perceived vocal impairment'}, {'measure': 'Phonation threshold pressure', 'timeFrame': '2 weeks', 'description': 'Objective aerodynamic measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vocal Cord Paralysis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the subjective, objective, and aerodynamic impact of voice rest following injection augmentation and compare the outcomes to patients with no post-procedure voice restrictions.', 'detailedDescription': 'Glottic insufficiency resulting from vocal fold immobility can have a significant negative impact on health and quality of life and is a major cause of dysphonia, dysphagia, and dyspnea. Vocal fold immobility can be unilateral or bilateral and complete or partial. Most commonly, it is caused by iatrogenic injury to the recurrent laryngeal nerve from thyroidectomy or anterior cervical disc fusion surgeries. Other causes include traumatic, idiopathic, malignant, and neurogenic. Variability exists in approach to surgical management. Degree of spontaneous recovery and thus timing of intervention varies based on severity and permanency of neurological injury. Initially described by Wilhelm Brünings in 1911, injection laryngoplasty, also known as injection augmentation, is a technique to improve glottic closure by injection of material to move the immobile vocal fold closer to midline. This improves voice quality and strain in patients with either unilateral or bilateral vocal fold hypomobility, immobility, atrophy, presbylarynx, vocal fold scar, and soft tissue loss. Improvement in glottic closure also results in better swallowing outcomes. Injection augmentation can be performed under general anesthesia in patients unable to tolerate the procedure while awake. Injection can be performed peroral, through a working channeled flexible laryngoscope, or a percutaneous approach. Percutaneous approaches can be further divided into transthyroid cartilage, transcricothyroid membrane, or transthyrohyoid membrane. All cases are performed under endoscopic guidance to ensure correct needle placement and adequate medialization of affected vocal fold. Congruent with the heterogeneity of injection laryngoplasty materials, approaches, and techniques, there also appears to be no data or expert consensus regarding voice rest following this procedure. This study aims to quantify the benefit of voice rest following vocal fold injection augmentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>18 years old\n2. Undergoing injection augmentation by Dr. McGarey, Dr. Torrecillas, or Dr. Daniero for the following conditions:\n\n 1. Glottic insufficiency from atrophy, scar, or presbylarynx\n 2. Unilateral or bilateral vocal fold immobility\n 3. Unilateral or bilateral vocal fold hypomobility\n\nExclusion Criteria:\n\n1. Prior history of head and neck radiation.\n2. Active or recent (within 3 months) chemotherapy.\n3. Age \\<18 years old\n4. Incarcerated individuals will be excluded due to inability to enroll in post-intervention clinic visit\n5. Presence of posterior glottic stenosis\n6. Presence of acute laryngeal injury\n7. Bedside inpatient injection augmentation\n8. Vocal fold Injection with steroids or cidofovir'}, 'identificationModule': {'nctId': 'NCT05542550', 'briefTitle': 'Voice Rest and Injection Laryngoplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HSR220245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Voice Rest', 'description': '48 hours of voice rest prescribed following injection', 'interventionNames': ['Behavioral: Voice Rest']}, {'type': 'EXPERIMENTAL', 'label': 'No voice rest', 'description': 'No voice rest required following injection', 'interventionNames': ['Behavioral: No Voice Rest']}], 'interventions': [{'name': 'Voice Rest', 'type': 'BEHAVIORAL', 'description': 'Voice rest restricting patient phonation', 'armGroupLabels': ['Voice Rest']}, {'name': 'No Voice Rest', 'type': 'BEHAVIORAL', 'description': 'No Voice rest', 'armGroupLabels': ['No voice rest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James J Daniero, MD', 'role': 'CONTACT', 'email': 'jjd5h@uvahealth.org', 'phone': '434-924-2040'}, {'name': 'Elena Miller', 'role': 'CONTACT', 'email': 'em8zk@uvahealth.org', 'phone': '4342433607'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'James J Daniero, MD', 'role': 'CONTACT', 'email': 'jjd5h@uvahealth.org', 'phone': '4349242040'}], 'overallOfficials': [{'name': 'James J Daniero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'James Daniero, MD', 'investigatorAffiliation': 'University of Virginia'}}}}