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| Sponsor: | University of Wisconsin, Madison |
|---|---|
| Collaborator: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Information provided by (Responsible Party): | 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: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Quantifying Effects of Treatment of Pediatric Dysphonia |
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2004 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 6 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: | J. Scott McMurray, MD | University of Wisconsin, Madison |
More Information
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00237679 History of Changes |
| Other Study ID Numbers: | HS-IRB #2000-487, R03DC005917 |
| Study First Received: | October 7, 2005 |
| Last Updated: | November 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
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Gastroesophageal Reflux Voice Disorders Dysphonia Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Laryngeal Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms Lansoprazole Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |