Gastroesophageal Reflux Clinical Trial
Official title:
Quantifying Effects of Treatment of Pediatric Dysphonia
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.
Status | Terminated |
Enrollment | 31 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 11 Years |
Eligibility |
Inclusion Criteria: - chronic dysphonia with suspected extraesophageal reflux Exclusion Criteria: - previous reflux treatment. - laryngeal disorder treated primarily with surgery |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children. | Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children. | 3 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05561179 -
Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease
|
N/A | |
Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
Completed |
NCT01946971 -
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01825473 -
Study of Erythromycin in GER-Associated Apnea of the Newborn
|
N/A | |
Completed |
NCT00614536 -
Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
|
Phase 4 | |
Completed |
NCT00373997 -
Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
|
Phase 4 | |
Completed |
NCT00284908 -
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00365300 -
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
Completed |
NCT00567021 -
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
|
N/A | |
Completed |
NCT00291746 -
Validation of RDQ Questionnaire
|
Phase 4 | |
Completed |
NCT00215787 -
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
|
N/A | |
Completed |
NCT00141960 -
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
|
Phase 2/Phase 3 | |
Completed |
NCT00226044 -
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
|
Phase 3 | |
Completed |
NCT01167543 -
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
|
N/A | |
Completed |
NCT01048840 -
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
|
||
Completed |
NCT00181805 -
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
|
||
Terminated |
NCT01281553 -
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
|
Phase 4 | |
Completed |
NCT05486169 -
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
|
N/A | |
Completed |
NCT04034017 -
Gastroesophageal Reflux Disease Among College Students
|
||
Terminated |
NCT03226054 -
Determining Risk Factors for Successful PPI Weaning
|
N/A |