Quantifying Effects of Treatment of Pediatric Dysphonia

This study has been terminated.
(Terminated due to funding loss.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00237679
First received: October 7, 2005
Last updated: May 1, 2013
Last verified: May 2013

October 7, 2005
May 1, 2013
January 2004
December 2008   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00237679 on ClinicalTrials.gov Archive Site
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Quantifying Effects of Treatment of Pediatric Dysphonia
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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Voice Disorders
  • Gastroesophageal Reflux
  • Behavioral: Neuromuscular Electrical Stimulation
    Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction.
  • Behavioral: Unstimulated
    No current is generated.
  • Active Comparator: Neuromuscular Electrical Stimulation
    Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.
    Intervention: Behavioral: Neuromuscular Electrical Stimulation
  • Sham Comparator: Unstimulated
    Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.
    Intervention: Behavioral: Unstimulated
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria:

  • previous reflux treatment.
  • laryngeal disorder treated primarily with surgery
Both
6 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00237679
HS-IRB #2000-487, R03DC005917
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: J. Scott McMurray, MD University of Wisconsin, Madison
University of Wisconsin, Madison
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP