Quantifying Effects of Treatment of Pediatric Dysphonia

This study has been terminated.
(Terminated due to funding loss.)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
First received: October 7, 2005
Last updated: October 13, 2015
Last verified: October 2015
The diagnosis and management of childhood dysphonia is a significant clinical problem; however, there have been few studies aimed at defining standard assessment methods for pediatric dysphonia. Accordingly, pediatric dysphonia is difficult to diagnose and it is difficult to quantify change following treatment. The long-term goal of this research program is to develop valid, responsive, reliable, and age-appropriate methods for assessing vocal pathology in children. In the present small grant, our objective is to define assessment methods that are appropriate for use in determining response to treatment. Our main focus, therefore, is the issue of assessment responsivity. The first specific aim is to develop a set of responsive measures of vocal pathology in school-aged children by inducing short-term change in vocal status via behavioral and medical management of extraesophageal reflux disease (EERD). Because we are treating children suspected of EERD, this study also presents the opportunity for examining the benefits of combined vocal hygiene and medical management in the treatment of pediatric EERD. Accordingly, our second specific aim is to determine predictive criteria for improvement in vocal status in dysphonic children suspected of EERD. Our hypothesis is that a particular set of measurements will emerge as particularly responsive to change in vocal pathology in this population, and will allow for informed prediction of degree of improvement with treatment. The proposed research is significant in filling a gap in knowledge in childhood dysphonia assessment and treatment, which are important clinical issues consistent with the mission and intent of the NIDCD. Because phonatory disorders in children may have lasting negative effects, studies geared toward accurate assessment and treatment are very important.

Condition Intervention
Voice Disorders
Gastroesophageal Reflux
Behavioral: Neuromuscular Electrical Stimulation
Behavioral: Unstimulated

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quantifying Effects of Treatment of Pediatric Dysphonia

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.

Enrollment: 31
Study Start Date: January 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neuromuscular Electrical Stimulation
Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.
Behavioral: Neuromuscular Electrical Stimulation
Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.
Sham Comparator: Unstimulated
Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.
Behavioral: Unstimulated
No current is generated.


Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria:

  • previous reflux treatment.
  • laryngeal disorder treated primarily with surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00237679

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: J. Scott McMurray, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00237679     History of Changes
Other Study ID Numbers: 2000-487  R03DC005917 
Study First Received: October 7, 2005
Last Updated: October 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
behavior therapy
combination therapy
gastrointestinal disorder chemotherapy
human therapy evaluation
larynx disorder
middle childhood (6-11)
reflux esophagitis
quality of life
clinical research
human subject
patient oriented research

Additional relevant MeSH terms:
Voice Disorders
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Laryngeal Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016