Quantifying Effects of Treatment of Pediatric Dysphonia

NCT ID: NCT00237679

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neuromuscular Electrical Stimulation

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

Group Type: ACTIVE_COMPARATOR

Neuromuscular Electrical Stimulation

Intervention Type: BEHAVIORAL

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

Unstimulated

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

Group Type: SHAM_COMPARATOR

Unstimulated

Intervention Type: BEHAVIORAL

No current is generated.

Interventions

Neuromuscular Electrical Stimulation

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

Intervention Type: BEHAVIORAL

Unstimulated

No current is generated.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• chronic dysphonia with suspected extraesophageal reflux

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Scott McMurray, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

R03DC005917

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000-487

Identifier Type: -

Identifier Source: org_study_id