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.
- Vocal Nodules
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: 1 year after start of voice therapy
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 4 - 11 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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
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
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
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
Is there still capacity for enrolment in this clinical experiment?
"According to the data hosted on clinicaltrials.gov 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
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
What is the total capacity for this clinical research endeavor?
"Affirmative. The clinicaltrials.gov 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
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