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No voice rest for Vocal Cord Paralysis

N/A

Recruiting

Led By James J Daniero, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Glottic insufficiency from atrophy, scar, or presbylarynx

Unilateral or bilateral vocal fold hypomobility

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial aims to see how taking a break from using your voice after an injection to improve it affects how it sounds and functions. We will compare the results to those who don't have any voice restrictions

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but may include discomfort from not speaking, strain from returning to normal voice use too soon, and variations in vocal quality.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My voice box is weak due to thinning, scarring, or aging.

Select...

My vocal cords move less than normal.

Select...

My vocal cords do not move as they should.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-perceived voice improvement

Secondary outcome measures

GRBAS- Grade, Roughness, Breathiness, Asthenia, Strain

Phonation threshold pressure

Trial Design

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverOTHER

1,738 Previous Clinical Trials

2,149,376 Total Patients Enrolled

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,244,923 Total Patients Enrolled

1 Trials studying Vocal Cord Paralysis

80 Patients Enrolled for Vocal Cord Paralysis

James J Daniero, MDPrincipal InvestigatorUniversity of Virginia

1 Previous Clinical Trials

80 Total Patients Enrolled

1 Trials studying Vocal Cord Paralysis

80 Patients Enrolled for Vocal Cord Paralysis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are 25 years old and above eligible to participate in this medical study?

"This study is open to individuals who are 18 years of age or older but less than 89 years old."

Answered by AI

Are individuals currently able to enroll in this ongoing medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is currently in search of eligible participants. The trial was initially posted on August 1st, 2023 and underwent its last update on January 17th, 2024. A total of 150 individuals are being recruited from a single site for this research endeavor."

Answered by AI

Do I meet the necessary criteria to participate in this research endeavor?

"To be eligible for participation in this clinical trial, patients must have diagnosed vocal cord paralysis and fall within the age range of 18 to 89. The study has a capacity to accept up to 150 participants."

Answered by AI

What is the upper limit on the number of individuals participating in this research endeavor?

"Indeed, the information available on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible participants. The study was initially posted on August 1st, 2023 and underwent its latest update on January 17th, 2024. This investigation aims to enroll a total of 150 patients from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Voice Rest and Injection Laryngoplasty

James Daniero, MD 2023. "Voice Rest and Injection Laryngoplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05542550.