跳至主要内容
临床试验/NCT00237679
NCT00237679终止不适用

Quantifying Effects of Treatment of Pediatric Dysphonia

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2004年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
31
试验地点
1
主要终点
Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •chronic dysphonia with suspected extraesophageal reflux

排除标准

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

研究组 & 干预措施

Neuromuscular Electrical Stimulation

Active Comparator

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

干预措施: Neuromuscular Electrical Stimulation (Behavioral)

Unstimulated

Sham Comparator

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

干预措施: Unstimulated (Behavioral)

结局指标

主要结局

Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.

时间窗: 3 years

Determine the effectiveness of medical treatment for hypopharyngeal EERD in dysphonic children.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验