Quantifying Effects of Treatment of Pediatric Dysphonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237679
Recruitment Status : Terminated (Terminated due to funding loss.)
First Posted : October 12, 2005
Last Update Posted : October 14, 2015
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Voice Disorders Gastroesophageal Reflux Behavioral: Neuromuscular Electrical Stimulation Behavioral: Unstimulated Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quantifying Effects of Treatment of Pediatric Dysphonia
Study Start Date : January 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children. [ Time Frame: 3 years ]
    Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria:

  • previous reflux treatment.
  • laryngeal disorder treated primarily with surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison Identifier: NCT00237679     History of Changes
Other Study ID Numbers: 2000-487
R03DC005917 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

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