Quantifying Effects of Treatment of Pediatric Dysphonia

Study Overview
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Brief Summary
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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.

Official Title
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Quantifying Effects of Treatment of Pediatric Dysphonia

Conditions
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Voice Disorders, Gastroesophageal Reflux

Intervention / Treatment
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* Behavioral: Neuromuscular Electrical Stimulation
* Behavioral: Unstimulated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic dysphonia with suspected extraesophageal reflux Exclusion Criteria: previous reflux treatment. laryngeal disorder treated primarily with surgery

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neuromuscular Electrical Stimulation<br>Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy. | Behavioral: Neuromuscular Electrical Stimulation<br>* Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.<br>|
| Sham Comparator: Unstimulated<br>Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy. | Behavioral: Unstimulated<br>* No current is generated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children. | Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavior therapy, combination therapy, gastrointestinal disorder chemotherapy, human therapy evaluation, larynx disorder, middle childhood (6-11), lansoprazole, reflux esophagitis, quality of life, clinical research, human subject, laryngoscopy, patient oriented research, questionnaire