Voice Rest for Vocal Cord Paralysis

Overseen By James J Daniero, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must not be taking: Steroids, Cidofovir

Disqualifiers: Head and neck radiation, Chemotherapy, Posterior glottic stenosis, Acute laryngeal injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how voice rest affects recovery after injection augmentation, a procedure for treating vocal cord issues. It compares two groups: one with 48 hours of voice rest and another with no voice restrictions post-procedure. Individuals with vocal cord problems, such as immobility or weakened movement, who are receiving treatment from specific doctors, may be suitable candidates for this trial. As an unphased study, it provides a unique opportunity to contribute to understanding recovery methods for vocal cord treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that voice rest is safe for vocal cord paralysis?

Research has shown that resting the voice after vocal cord surgery aids healing and improves recovery. A review of studies on vocal cord surgery found that taking a break from talking, known as voice rest, benefits healing. Giving vocal cords some time off might enhance their recovery.

Regarding the injection procedure, studies indicate it is generally safe and effective. Patients have not reported major problems from the injections used to treat vocal cord paralysis. Overall, both voice rest and the injection treatment are considered safe options.

For those considering joining a trial involving these treatments, it is reassuring to know they have been well-tolerated in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for vocal cord paralysis, which often involve surgery or voice therapy, this trial is exploring the benefits of a simple protocol: voice rest. Researchers are excited to find out if a brief, 48-hour period of voice rest following an injection can aid recovery. This approach is non-invasive and could offer a quicker, less complicated recovery method compared to more intensive treatments. By comparing voice rest to no rest, the trial aims to determine if rest can significantly enhance healing, potentially changing how we approach treatment for vocal cord paralysis.

What evidence suggests that voice rest might be an effective treatment for vocal cord paralysis?

Research shows that resting the voice after vocal cord surgery can aid recovery. In this trial, participants will join either a "Voice Rest" group, where 48 hours of voice rest follows the injection, or a "No Voice Rest" group, where no voice rest is required. Studies have found that voice rest helps the vocal cords heal. For individuals with vocal cord paralysis, one study found that 46.9% of patients experienced improved vocal cord movement. Another study showed that 69% of patients regained vocal cord movement within six months with proper voice care. These findings suggest that resting the voice can be an effective part of treatment for vocal cord issues. ^{3 6 7 8 9}

Who Is on the Research Team?

James J Daniero, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: No voice rest Experimental Treatment 1 Intervention

No voice rest required following injection

Group II: Voice Rest Active Control 1 Intervention

48 hours of voice rest prescribed following injection

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40447797/

Voice rest after vocal fold surgery: a systematic review of ... This systematic review aimed to evaluate the efficacy of VR in facilitating recovery and improving outcomes after vocal cord surgery. Methods: A systematic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11623809/

Summary of the best evidence for vocal rehabilitation ... Purpose: To search, evaluate, and summarize the relevant evidence of voice rehabilitation training in adults with unilateral vocal fold paralysis (UVFP).

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/482167

Prognostic Value of Laryngeal Electromyography in Vocal ... In our study, free mobility of the paralyzed vocal fold was restored in only 8.1%, while 46.9% of all paralyzed vocal folds improved at least to a certain ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022510X09005255#!

Idiopathic vocal fold paralysis: Clinical course and outcomes Spontaneous improvement of vocal fold function was observed in 25% of patients with long-term follow up. Of those with unilateral paralysis, 27% ...

5. e-ceo.org e-ceo.org/journal/view.php?number=736

:: Clinical and Experimental Otorhinolaryngology Thirty-eight of the 55 patients (69%) recovered vocal fold movement, and this occurred within 6 months of onset in two-thirds of patients. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9194994/

Long‐term results and safety of fibroblast growth factor ... Basic fibroblast growth factor (bFGF) injection can improve dysphonia of unilateral vocal fold paralysis (UVFP).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05542550

NCT05542550 | Voice Rest and Injection Laryngoplasty The purpose of this study is to evaluate the subjective, objective, and aerodynamic impact of voice rest following injection augmentation and compare the ...

8. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2024/12000/summary_of_the_best_evidence_for_vocal.50.aspx

Summary of the best evidence for vocal rehabilitation... Evidence shows that patients with vocal cord paralysis should pay attention to voice rest. Relevant consultation methods were provided to patients, and ...

9. ejo.springeropen.com ejo.springeropen.com/articles/10.1186/s43163-020-00064-8

Outcomes versus complications in patients undergoing ... Vocal fold injection is considered a safe, reliable, and highly effective method of treatment. The purpose of the present study was to assess ...