Standard voice therapy for Vocal Nodules

Phase-Based Progress Estimates
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PAVocal NodulesStandard voice therapy - Behavioral
4 - 11
All Sexes
What conditions do you have?

Study Summary

This trial will help determine if a short-course of inhaled corticosteroids in addition to standard voice therapy is safe and effective for treating vocal fold nodules in children.

Eligible Conditions
  • Vocal Nodules

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 1 year after start of voice therapy

Year 1
adverse events
4 weeks
compliance with inhaler use (percent of prescribed doses marked as "taken" on diary)
9-12 weeks
fundamental frequency (Hertz)
maximum phonation time (seconds)
quality of life questionnaire
s/z ratio

Trial Safety

Trial Design

1 Treatment Group

inhaled steroid + voice therapy
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Standard voice therapy · No Placebo Group · Phase 1

inhaled steroid + voice therapyExperimental Group · 2 Interventions: Fluticasone propionate, Standard voice therapy · Intervention Types: Drug, Behavioral
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluticasone propionate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year after start of voice therapy

Who is running the clinical trial?

Joseph Dohar, MDLead Sponsor

Eligibility Criteria

Age 4 - 11 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not received any voice therapy in the past.
You must be willing to attend voice therapy sessions at Children's Hospital of Pittsburgh.
The person in charge of the study thinks you are mentally and emotionally ready for voice therapy.

Frequently Asked Questions

Is this experiment actively recruiting participants who are seventy or older in age?

"The cutoff age for this clinical trial is 11, with prospective participants needing to be at least 4 years old. There are also 20 trials open to minors and 89 available for elderly patients over the age of 65." - Anonymous Online Contributor

Unverified Answer

What are the primary goals of this research endeavor?

"This 4-week clinical trial will measure adverse events, along with alterations in fundamental frequency (measured in Hertz), maximum phonation time (in seconds) and s/z ratio." - Anonymous Online Contributor

Unverified Answer

Who is the appropriate cohort for this experiment?

"To be accepted in this trial, children must have respiratory aspiration, aged between 4 and 11. A total of 12 participants are being admitted to the study." - Anonymous Online Contributor

Unverified Answer

To what disorders is Standard voice therapy typically applied?

"Vocal therapy is an effective method of treating eosinophilic esophagitis (eoe), as well as asthma, allergies to mould and sinus infections." - Anonymous Online Contributor

Unverified Answer

Is there still capacity for enrolment in this clinical experiment?

"According to the data hosted on this medical study, which was initially made available on March 1st 2017, is enrolling volunteers. The details of the trial were most recently edited and updated as of July 8th 2022." - Anonymous Online Contributor

Unverified Answer

Is the utilization of Standard voice therapy sanctioned by the FDA?

"Our team at Power assigned a score of 1 to Standard Voice Therapy's safety because this is an initial Phase 1 trial, where the evidence for both safety and efficacy remains sparse." - Anonymous Online Contributor

Unverified Answer

What is the total capacity for this clinical research endeavor?

"Affirmative. The portal conveys that this research is actively enrolling volunteers, with 12 patients needed from 1 site since its March 1st 2017 launch date and most recent July 8th 2022 revision." - Anonymous Online Contributor

Unverified Answer

Could you provide a brief overview of the other research conducted related to Standard voice therapy?

"Currently, 10 different clinical trials researching Standard voice therapy are underway. 2 of those active studies have reached Phase 3 status. The majority are located in Palo Alto, California though 14 total sites exist for this specific procedure." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.