Quantifying Effects of Treatment of Pediatric Dysphonia
Information source: University of Wisconsin, Madison
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Voice Disorders; Gastroesophageal Reflux
Intervention: lansoprazole (Drug); Voice Therapy (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s):
J. Scott McMurray, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison
Overall contact:
J. Scott McMurray, MD, Phone: 608-262-7181, Email: mcmurray@surgery.wisc.edu
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.
Clinical Details
Official title: Quantifying Effects of Treatment of Pediatric Dysphonia
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Eligibility
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- chronic dysphonia with suspected extraesophageal reflux
Exclusion Criteria:
- previous reflux treatment.
- laryngeal disorder treated primarily with surgery
Locations and Contacts
J. Scott McMurray, MD, Phone: 608-262-7181, Email: mcmurray@surgery.wisc.edu
University of Wisconsin, Madison, Wisconsin 53792, United States; Recruiting
J. Scott McMurray, MD, Phone: 608-262-7181, Email: mcmurray@surgery.wisc.edu
J. Scott McMurray, MD, Principal Investigator
Additional Information
Starting date: January 2004
Last updated: October 11, 2005
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