Quantifying Effects of Treatment of Pediatric Dysphonia
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
Subjects will receice Neuromuscular Electrical Stimulation (NMES)-stimulated swallowing combined with exercise therapy.
干预措施: Neuromuscular Electrical Stimulation (Behavioral)
Unstimulated
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
