Clinical trial NCT00237679: Quantifying Effects of Treatment of Pediatric Dysphonia
Official title: Quantifying Effects of Treatment of Pediatric Dysphonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Voice Disorders
Gastroesophageal Reflux
Keywords: 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
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2005-10-12
Enrollment: 31
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria:

* previous reflux treatment.
* laryngeal disorder treated primarily with surgery

Primary outcomes:
measure: Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: J. Scott McMurray, MD
role: PRINCIPAL_INVESTIGATOR
References: