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Quantifying Effects of Treatment of Pediatric Dysphonia

Quantifying Effects of Treatment of Pediatric Dysphonia

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00237679
Enrollment
31
Registered
2005-10-12
Start date
2004-01-31
Completion date
2008-12-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux, Voice Disorders

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

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.

Interventions

BEHAVIORALNeuromuscular Electrical Stimulation

Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.

BEHAVIORALUnstimulated

No current is generated.

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

* chronic dysphonia with suspected extraesophageal reflux

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.3 yearsDetermine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026