Voice Rest for Vocal Cord Paralysis
JD
JJ
Overseen ByJames J Daniero, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this 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.
Research Team
JJ
James J Daniero, MD
Principal Investigator
University of Virginia
Eligibility Criteria
This trial is for individuals with vocal cord paralysis or limited movement, regardless of previous treatments or where the injection was done. It includes those with voice issues due to aging, scarring, or muscle atrophy. Participants must be able to complete a specific voice handicap index survey.Inclusion Criteria
My voice box is weak due to thinning, scarring, or aging.
I will receive injections in both the operating room and the doctor's office.
I have had an injection before.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo injection laryngoplasty with or without voice rest
2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
1 visit (in-person)
Treatment Details
Interventions
- No Voice Rest
- Voice Rest
Trial Overview The study compares two approaches after a person receives an injection to improve their vocal cords: one group will have strict voice rest while the other won't have any speaking restrictions. The impact on voice quality and airflow during speech is measured.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: No voice restExperimental Treatment1 Intervention
No voice rest required following injection
Group II: Voice RestActive Control1 Intervention
48 hours of voice rest prescribed following injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Trials
802
Recruited
1,342,000+
University of Colorado, Denver
Collaborator
Trials
1,842
Recruited
3,028,000+
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