Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial
Primary Purpose
Vocal Cord Paralysis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Voice Rest
No Voice Rest
Sponsored by
About this trial
This is an interventional treatment trial for Vocal Cord Paralysis
Eligibility Criteria
Inclusion Criteria:
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age >18 years old 4. Undergoing injection augmentation by Dr. McGarey or Dr. Daniero for the following conditions:
- Glottic insufficiency from atrophy, scar, or presbylarynx
- Unilateral or bilateral vocal fold immobility
- Unilateral or bilateral vocal fold hypomobility
Additional considerations
- Patient can be included if they have undergone a previous injection
- Any injection material will be included
- Injections in both the operating room and office will be included
- Non-english speakers will be included, as long as they are able to complete the VHI-10
Exclusion Criteria:
- 1. Prior history of head and neck radiation. 2. Active or recent (within 3 months) chemotherapy. 3. Age <18 years old 4. Incarcerated individuals will be excluded due to inability to enroll in post-intervention clinic visit 5. Presence of posterior glottic stenosis 6. Presence of acute laryngeal injury 7. Bedside inpatient injection augmentation 8. Vocal fold Injection with steroids or cidofovir
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Voice Rest
No voice rest
Arm Description
48 hours of voice rest prescribed following injection
No voice rest required following injection
Outcomes
Primary Outcome Measures
Patient-perceived voice improvement
VHI-10
Secondary Outcome Measures
GRBAS
Physician-perceived improvement in voice
Phonation threshold pressure
OBjective aerodynamic measure
Full Information
NCT ID
NCT05542550
First Posted
September 12, 2022
Last Updated
September 12, 2022
Sponsor
University of Virginia
Collaborators
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05542550
Brief Title
Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial
Official Title
Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Cord Paralysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized to one of two arms: no voice rest following injection and 48 hours voice rest following injection
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Only patient is aware of treatment group
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Voice Rest
Arm Type
Active Comparator
Arm Description
48 hours of voice rest prescribed following injection
Arm Title
No voice rest
Arm Type
Experimental
Arm Description
No voice rest required following injection
Intervention Type
Behavioral
Intervention Name(s)
Voice Rest
Intervention Description
Voice rest restricting patient phonation
Intervention Type
Behavioral
Intervention Name(s)
No Voice Rest
Intervention Description
No Voice rest
Primary Outcome Measure Information:
Title
Patient-perceived voice improvement
Description
VHI-10
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
GRBAS
Description
Physician-perceived improvement in voice
Time Frame
2 weeks
Title
Phonation threshold pressure
Description
OBjective aerodynamic measure
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age >18 years old 4. Undergoing injection augmentation by Dr. McGarey or Dr. Daniero for the following conditions:
Glottic insufficiency from atrophy, scar, or presbylarynx
Unilateral or bilateral vocal fold immobility
Unilateral or bilateral vocal fold hypomobility
Additional considerations
Patient can be included if they have undergone a previous injection
Any injection material will be included
Injections in both the operating room and office will be included
Non-english speakers will be included, as long as they are able to complete the VHI-10
Exclusion Criteria:
1. Prior history of head and neck radiation. 2. Active or recent (within 3 months) chemotherapy. 3. Age <18 years old 4. Incarcerated individuals will be excluded due to inability to enroll in post-intervention clinic visit 5. Presence of posterior glottic stenosis 6. Presence of acute laryngeal injury 7. Bedside inpatient injection augmentation 8. Vocal fold Injection with steroids or cidofovir
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julian De La Chapa, MD
Phone
2103238070
Email
delachapa@virginia.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial
We'll reach out to this number within 24 hrs