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Quantifying Effects of Treatment of Pediatric Dysphonia
This study is currently recruiting participants.
Verified by University of Wisconsin, Madison, October 2005
First Received: October 7, 2005   Last Updated: October 11, 2005   History of Changes
Sponsor: University of Wisconsin, Madison
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00237679
  Purpose

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 Intervention
Voice Disorders
Gastroesophageal Reflux
Drug: lansoprazole
Behavioral: Voice Therapy

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Quantifying Effects of Treatment of Pediatric Dysphonia

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 50
Study Start Date: January 2004
  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria:

  • previous reflux treatment.
  • laryngeal disorder treated primarily with surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237679

Contacts
Contact: J. Scott McMurray, MD 608-262-7181 mcmurray@surgery.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: J. Scott McMurray, MD     608-262-7181     mcmurray@surgery.wisc.edu    
Principal Investigator: J. Scott McMurray, MD            
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: J. Scott McMurray, MD University of Wisconsin, Madison
  More Information

No publications provided

Study ID Numbers: HS-IRB #2000-487, 5R03DC005917
Study First Received: October 7, 2005
Last Updated: October 11, 2005
ClinicalTrials.gov Identifier: NCT00237679     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
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

Additional relevant MeSH terms:
Anti-Infective Agents
Disease
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Nervous System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Signs and Symptoms
Pathologic Processes
Digestive System Diseases
Respiratory Tract Diseases
Therapeutic Uses
Anti-Ulcer Agents
Neurologic Manifestations
Lansoprazole
Voice Disorders
Esophageal Diseases
Laryngeal Diseases

ClinicalTrials.gov processed this record on February 08, 2010