Evaluating voice rest after injection laryngoplasty for vocal cord paralysis
Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial
This study is testing whether taking a break from using your voice after a specific throat procedure helps people with vocal cord paralysis recover better than if they don’t rest their voice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05542550 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effects of voice rest following injection laryngoplasty on patients with vocal cord paralysis. It will compare subjective and objective outcomes between patients who undergo voice rest and those who do not after the procedure. Injection laryngoplasty is performed to improve glottic closure, enhancing voice quality and swallowing function. The study will involve patients over 18 years old who are receiving this treatment for various causes of vocal fold immobility or hypomobility.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with vocal cord paralysis due to conditions like atrophy, scar, or immobility.
Not a fit: Patients with a history of head and neck radiation, recent chemotherapy, or acute laryngeal injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for patients with vocal cord paralysis, enhancing their voice quality and overall quality of life.
How similar studies have performed: While injection laryngoplasty is a well-established procedure, the specific evaluation of voice rest post-procedure is less commonly studied, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: James J Daniero, MD — University of Virginia
- Study coordinator: James J Daniero, MD
- Email: jjd5h@uvahealth.org
- Phone: 4349242040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.