Recruiting

Voice Rest & Injection Laryngoplasty

Sponsor:

University of Virginia

Code:

NCT05542550

Conditions

Vocal Cord Paralysis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Voice Rest

No Voice Rest

Study Details

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.

Conditions

Vocal Cord Paralysis

Study ID

NCT05542550

Start date

Aug 1, 2023

Status verified date

Jan, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Voice Rest

48 hours of voice rest prescribed following injection

experimental: No voice rest

No voice rest required following injection

Interventions

Voice Rest

Voice rest restricting patient phonation

No Voice Rest

No Voice rest

Primary outcome measure

  • Patient-perceived voice improvement [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

James J Daniero, MD

4349242040jjd5h@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

James J Daniero, MD

434-924-2040jjd5h@uvahealth.org

Elena Miller

4342433607em8zk@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

Jan 19, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-01-19.