Trial record 13 of 43 for:    "Voice Disorders"

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
  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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria:

  • previous reflux treatment.
  • laryngeal disorder treated primarily with surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237679

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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 July 28, 2014