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Quantifying Effects of Treatment of Pediatric Dysphonia

Primary Purpose

Voice Disorders, Gastroesophageal Reflux

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation
Unstimulated
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Voice Disorders focused on measuring 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

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Neuromuscular Electrical Stimulation

Unstimulated

Arm Description

Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.

Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.

Outcomes

Primary Outcome Measures

Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2005
Last Updated
October 13, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00237679
Brief Title
Quantifying Effects of Treatment of Pediatric Dysphonia
Official Title
Quantifying Effects of Treatment of Pediatric Dysphonia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to funding loss.
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Disorders, Gastroesophageal Reflux
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Electrical Stimulation
Arm Type
Active Comparator
Arm Description
Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.
Arm Title
Unstimulated
Arm Type
Sham Comparator
Arm Description
Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.
Intervention Type
Behavioral
Intervention Name(s)
Neuromuscular Electrical Stimulation
Intervention Description
Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.
Intervention Type
Behavioral
Intervention Name(s)
Unstimulated
Intervention Description
No current is generated.
Primary Outcome Measure Information:
Title
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
Description
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic dysphonia with suspected extraesophageal reflux Exclusion Criteria: previous reflux treatment. laryngeal disorder treated primarily with surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Scott McMurray, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Quantifying Effects of Treatment of Pediatric Dysphonia

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