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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
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vocal Cord Paralysis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

    1. Glottic insufficiency from atrophy, scar, or presbylarynx
    2. Unilateral or bilateral vocal fold immobility
    3. Unilateral or bilateral vocal fold hypomobility
    4. 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

    First Posted
    September 12, 2022
    Last Updated
    September 12, 2022
    Sponsor
    University of Virginia
    Collaborators
    University of Colorado, Denver
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    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

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    Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial

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