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Terminated due to funding loss.
Sponsor study identifier
Secondary identifiers
NIH
interventional
31
1 country
1
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
October 7, 2005
Actual (reported)October 12, 2005
Actual (reported)December 2008
Actual (reported)December 2008
Actual (reported)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
Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.
Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.
Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.
No current is generated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Wisconsin
Madison, Wisconsin, 53792, United States
J. Scott McMurray, MD
University of Wisconsin, Madison
31 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)Last Updated
October 14, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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