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Sponsored by: |
University of Wisconsin, Madison |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00237679 |
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 |
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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 |
Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: J. Scott McMurray, MD | 608-262-7181 | mcmurray@surgery.wisc.edu |
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 |
Principal Investigator: | J. Scott McMurray, MD | University of Wisconsin, Madison |
Study ID Numbers: | HS-IRB #2000-487, 5R03DC005917 |
Study First Received: | October 7, 2005 |
Last Updated: | October 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00237679 |
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 |
Otorhinolaryngologic Diseases Esophageal disorder Gastrointestinal Diseases Quality of Life Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Signs and Symptoms Esophagitis |
Esophagitis, Peptic Digestive System Diseases Respiratory Tract Diseases Neurologic Manifestations Lansoprazole Voice Disorders Laryngeal Diseases Esophageal Diseases |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Nervous System Diseases Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |