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Quantifying Effects of Treatment of Pediatric Dysphonia

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Terminated

Conditions

Voice Disorders
Gastroesophageal Reflux

Treatments

Behavioral: Unstimulated
Behavioral: Neuromuscular Electrical Stimulation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00237679
R03DC005917 (U.S. NIH Grant/Contract)
2000-487

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • chronic dysphonia with suspected extraesophageal reflux

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 2 patient groups

Neuromuscular Electrical Stimulation
Active Comparator group
Description:
Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.
Treatment:
Behavioral: Neuromuscular Electrical Stimulation
Unstimulated
Sham Comparator group
Description:
Subjects will receive sham (unstimulated) swallow therapy combined with exercise therapy.
Treatment:
Behavioral: Unstimulated

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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