Quantifying Effects of Treatment of Pediatric Dysphonia

NCT00237679 | Terminated DMC

• 2 other identifiers: 2000-487R03DC005917
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Neuromuscular Electrical Stimulation

ACTIVE COMPARATOR

Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.

Behavioral: Neuromuscular Electrical Stimulation

Unstimulated

SHAM COMPARATOR

Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.

Behavioral: Unstimulated

Interventions

Neuromuscular Electrical Stimulation BEHAVIORAL

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

Neuromuscular Electrical Stimulation

Unstimulated BEHAVIORAL

No current is generated.

Unstimulated

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• chronic dysphonia with suspected extraesophageal reflux

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Voice Disorders; Gastroesophageal Reflux; Laryngeal Diseases; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• J. Scott McMurray, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: January 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)