RECRUITING

Voice Rest and Injection Laryngoplasty

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Conditions

Vocal Cord Paralysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial

Quick Facts

Study Start:2023-08-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05542550

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>18 years old
  2. 2. Undergoing injection augmentation by Dr. McGarey, Dr. Torrecillas, or Dr. Daniero for the following conditions:
  3. 1. Glottic insufficiency from atrophy, scar, or presbylarynx
  4. 2. Unilateral or bilateral vocal fold immobility
  5. 3. Unilateral or bilateral vocal fold hypomobility
  1. 1. Prior history of head and neck radiation.
  2. 2. Active or recent (within 3 months) chemotherapy.
  3. 3. Age \<18 years old
  4. 4. Incarcerated individuals will be excluded due to inability to enroll in post-intervention clinic visit
  5. 5. Presence of posterior glottic stenosis
  6. 6. Presence of acute laryngeal injury
  7. 7. Bedside inpatient injection augmentation
  8. 8. Vocal fold Injection with steroids or cidofovir

Contacts and Locations

Study Contact

James J Daniero, MD
CONTACT
4349242040
jjd5h@uvahealth.org

Principal Investigator

James J Daniero, MD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • James J Daniero, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Vocal Cord Paralysis