Quantifying Effects of Treatment of Pediatric Dysphonia
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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 |
Behavioral: Neuromuscular Electrical Stimulation Behavioral: Unstimulated |
| Study Type: | Interventional |
| Study Design: | Allocation: 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 |
- Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children. [ Time Frame: 3 years ] [ Designated as safety issue: No ]Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
| Enrollment: | 31 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Neuromuscular Electrical Stimulation
Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.
|
Behavioral: Neuromuscular Electrical Stimulation
Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.
|
|
Sham Comparator: Unstimulated
Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.
|
Behavioral: Unstimulated
No current is generated.
|
Eligibility| Ages Eligible for Study: | 6 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- chronic dysphonia with suspected extraesophageal reflux
Exclusion Criteria:
- previous reflux treatment.
- laryngeal disorder treated primarily with surgery
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
No publications provided
| 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: | May 1, 2013 |
| 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:
|
Voice Disorders Gastroesophageal Reflux 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 |
ClinicalTrials.gov processed this record on May 22, 2013