Prospective Study of Voice Therapy in Children: A Pilot Study

Vocal Fold Nodules Clinical Trial

Status Completed

Clinical Trial Summary

The purpose of this prospective study is to obtain preliminary data on changes in pre-post voice therapy outcomes in children diagnosed with vocal fold nodules, as a function of a series of cognitive operations. The primary outcome is voice-related quality of life (questionnaire). Secondary outcomes are standard acoustic and aerodynamic measures derived from sustained vowel and running speech samples.

Clinical Trial 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, and may affect up to 21% of the pediatric population at any given point in time.

• Children with voice disorders caused by this and other conditions often experience negative consequences in quality of life and academic participation.

• Specifically, these children are at increased risk for inferior school performance, dysfunctional psychosocial development, and other negative sequelae.

• Overwhelmingly, the first-line treatment for voice problems due to nodules is behavioral voice therapy.

• Unfortunately, the pediatric population is badly underserved by Speech-Language Pathology for this condition and others affecting voice.

• Moreover, to date, experimental findings on the benefits of voice therapy in children have not been reported.

• In the present study, children who present with voice complaints to the Department of Otolaryngology at Children's Hospital of Pittsburgh (CHP), who are diagnosed with vocal fold nodules, and who following informed consent are found to satisfy other inclusion criteria detailed shortly, will be eligible for participation in the study.

• Eligible children will undergo a 45-60-min battery of standardized tests evaluating simple cognitive functions.

• Participation in the protocol will not depend on the outcome of these tests.

• Then, all children will receive an increasingly used, 9-week program of voice therapy for children with vocal fold nodules and other conditions affecting voice, "Adventures in Voice," a program grounded in basic biomechanical, biological, and cognitive science.

• Dependent variables will be pre- to post-therapy change in voice-related quality-of-life, based on the Pediatric Voice-Related Quality of Life Survey (Boseley, Cunningham, Volk, & Hartnick, 2006) (primary outcome measure) and change in a series of standard acoustic and aerodynamic measures based on sustained vowel and simple running speech samples, described shortly (secondary outcome measures).

• The independent variables involve a series of cognitive measures. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vocal Fold Nodules

• NCT number: NCT02217111
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Completion date: May 2015