Vocal Fold Nodules
Conditions
Keywords
vocal fold nodules, inhaled steroid, steroid, children, nodules
Brief summary
Voice disorders are the most common communication disorder across the lifespan and vocal fold nodules are the most frequent pathology affecting voice in children. The goal of the present study is to determine the safety, feasibility, and efficacy of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules.
Detailed description
Voice disorders are the most common communication disorder across the lifespan, affecting more than 5 million school-aged children annually in the United States. Vocal fold nodules are the most frequent pathology affecting voice in children, with 21% of children negatively influenced at any given point in time, resulting in negative quality of life consequences and inferior academic performance. The traditional first-line approach to treatment of vocal fold nodules is voice therapy by Speech-Language Pathology, although corticosteroids are often implemented in conjunction with voice therapy to reduce focal inflammation at the lesion site. Operating room procedures are the traditional method to administer corticosteroids to the lesion site, although recent advances in office-based laryngeal steroid injections have become a widely popular alternative to reduce lesion size. Unfortunately, although in-office injections are more favorable to operating room procedures, due to their less invasive nature, in-office procedures are still an invasive alternative in the pediatric population. Specifically, they involve equipment that may be intimidating to the child and require the child to remain very still for prolonged periods of time, which may not be feasible with some children. Furthermore, focal vocal fold injections still involve potential adverse effects such as vocal fold hematoma. To mediate these concerns, a short course of inhaled corticosteroids may be a safe and non-invasive alternative to reducing inflammation and lesion size within the larynx. The goal of the present study is to determine the safety and feasibility of a short-course of inhaled corticosteroids in addition to standard voice therapy for treating vocal fold nodules. The study also aims to examine the effects of inhaled corticosteroids on quality of life outcomes and acoustic and aerodynamic outcomes.
Interventions
DRUGFluticasone propionate
fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks
BEHAVIORALStandard voice therapy
Standard voice therapy sessions
Sponsors
Joseph Dohar, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed with vocal fold nodules; * Considered behaviorally and cognitively appropriate by PI for voice therapy; * English comprehension and production sufficient to participate in the protocol and in voice therapy; * Not currently on inhaled corticosteroids; * No previous voice therapy; * Willing to participate in voice therapy at Children's Hospital of Pittsburgh
Exclusion criteria
* Other medical conditions or medications that would mask or amplify voice outcomes, including developmental or other neuromuscular conditions, major illness or disorders, chronic or acute with the exception of laryngopharyngeal reflux disease or allergies and their treatments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 1 year after start of voice therapy | number and type of adverse events |
| compliance with inhaler use (percent of prescribed doses marked as taken on diary) | 4 weeks | percent of prescribed doses marked as taken on diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fundamental frequency (Hertz) | 9-12 weeks | change in fundamental frequency from baseline to end of therapy |
| quality of life questionnaire | 9-12 weeks | change in score from QOL questionnaire from baseline to end of therapy |
| maximum phonation time (seconds) | 9-12 weeks | change in time from baseline to end of therapy |
| s/z ratio | 9-12 weeks | change in ratio of 2 measures from baseline to end of therapy |
Countries
United States
Outcome results
None listed