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Clinical Trials/NCT02217111
NCT02217111
Completed
N/A

Prospective Study of Voice Therapy in Children: A Pilot Study

University of Pittsburgh2 sites in 1 country12 target enrollmentJanuary 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vocal Fold Nodules
Sponsor
University of Pittsburgh
Enrollment
12
Locations
2
Primary Endpoint
Pediatric Voice-Related Quality of Life Survey (PVRQOL)
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

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, 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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kittie Verdolini Abbott

Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of vocal fold nodules.
  • Age 4-11 yr.
  • Informed Consent.
  • English comprehension and production sufficient to participate in the protocol and in voice therapy.
  • Considered behaviorally and cognitively appropriate by the ear, nose, and throat physician and speech-language pathologist for voice therapy.
  • Parent and child willingness to participate in all aspects of the protocol and voice therapy.

Exclusion Criteria

  • Co-morbid medical conditions or medications that would mask or amplify the outcome of voice therapy, including (a) developmental or other neuromuscular conditions, (b) major illness, chronic or acute, with the exception of laryngopharyngeal reflux disease (LPR) or allergies and their treatments, which are common in both children and adults with voice disorders, thus their exclusion would severely restrict the participant pool and, moreover, threaten external validity.
  • Hearing loss: \> 20 dB hearing loss at 1000, 2000, 4000 Hz in at least one ear.

Outcomes

Primary Outcomes

Pediatric Voice-Related Quality of Life Survey (PVRQOL)

Time Frame: 13-16 weeks

The PVRQOL is a 10-item instrument designed and validated as a self-administered and parent-proxy-administered instrument for the pediatric population with voice disorders to measure both social-emotional and physical-functional aspects of voice problems. The PVRQOL raw scores are transformed to a scale of 0-100 for easy of interpretation. The PVRQOL will be administered prior to initiation of voice therapy as well as one week post-voice therapy termination.

Secondary Outcomes

  • Developmental Neuropsychological Assessment (NEPSY) (Cognitive Assessment)(13-16 weeks)
  • Vital Capacity (Aerodynamic Analysis)(13-16 weeks)
  • Browns ADD Scales (Cognitive Assessment)(13-16 weeks)
  • Maximum Phonation Time (Aerodynamic Analysis)(13-16 weeks)
  • Children's Memory Scale (Cognitive Assessment)(13-16 weeks)
  • Spectral and Cepstral Analysis(13-16 weeks)
  • S/Z Ratio (Aerodynamic Analysis)(13-16 weeks)

Study Sites (2)

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