Voice Rest and Injection Laryngoplasty

Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Vocal Cord Paralysis
• Intervention / Treatment: Behavioral: Voice Rest; Behavioral: No Voice Rest

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James J Daniero, MD; Phone Number: 4349242040; Email: jjd5h@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: James J Daniero, MD; Phone Number: 434-924-2040; Email: jjd5h@uvahealth.org
      • Contact: Elena Miller; Phone Number: 4342433607; Email: em8zk@uvahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age >18 years old

2. Undergoing injection augmentation by Dr. McGarey, Dr. Torrecillas, 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Voice Rest; 48 hours of voice rest prescribed following injection	Behavioral: Voice Rest; Voice rest restricting patient phonation
Experimental: No voice rest; No voice rest required following injection	Behavioral: No Voice Rest; No Voice rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-perceived voice improvement	Voice Handicap Index - 10. Scale range 0-40. Lower score designates lower voice impairment	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GRBAS- Grade, Roughness, Breathiness, Asthenia, Strain	Clinician-perceived improvement in voice. Range is 0-15. Lower score indicates lower perceived vocal impairment	2 weeks
Phonation threshold pressure	Objective aerodynamic measure	2 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: James J Daniero, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Paralysis; Vocal Cord Paralysis
• Other Study ID Numbers: HSR220245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No