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临床试验/NCT02877784
NCT02877784已完成不适用

Determination of Accurate Screening Tools for Dysphagia in Oculopharyngeal Muscular Dystrophy

University of Florida1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Dynamic Imaging Grade of Swallowing Toxicity

研究概览

简要总结

Oculopharyngeal muscular dystrophy (OPMD) is a rare myopathic disease that results in progressive degeneration of the oral and pharyngeal muscular, resulting in severe dysphagia and dysarthria. OPMD is considered a rare disease; therefore, limited research is available on the natural progression of the disease or the utility of biomarkers to identify swallowing impairment. The aim of this study is:

  1. To identify accurate, reliable and non-invasive clinical markers of swallowing impairment
  2. To determine the discriminate ability of these markers to identify impairments in swallow safety and swallowing efficiency.

详细描述

Participants will be recruited from the Neurology clinic at the University of Florida. The single evaluation will occur in the PIs research laboratory at the University of Florida, Gainesville, Florida.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of oculopharyngeal muscular dystrophy
  • no allergies to barium or capsaicin,
  • no tracheotomy or mechanical ventilation
  • no significant concurrent respiratory disease (e.g., COPD).

排除标准

  • Pregnant Women

结局指标

主要结局

Dynamic Imaging Grade of Swallowing Toxicity

时间窗: Baseline

Global Metric of swallowing Safety and Efficiency

次要结局

  • Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)(Baseline)
  • Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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