Quantifying Effects of Treatment of Pediatric Dysphonia

Not Applicable

Terminated

• Conditions: Voice Disorders; Gastroesophageal Reflux
• Interventions: Behavioral: Neuromuscular Electrical Stimulation; Behavioral: Unstimulated

• Registration Number: NCT00237679
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-11
• Study First Posted: 2005-10-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neuromuscular Electrical Stimulation	Neuromuscular Electrical Stimulation	Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.
Unstimulated	Unstimulated	Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.

Primary Outcome Measures

Name	Time	Method
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.	3 years	Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States