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临床试验/NCT02243722
NCT02243722Unknown不适用

Establish Comprehensive Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
Fiberoptic endoscopic evaluation of swallowing (FEES)

研究概览

简要总结

Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance, which often happens after the treatment for laryngopharyngeal and esophageal cancer and may induce fatal complications such as aspiration pneumonia. By the conventional examinations, the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. It is utmost important to establish a comprehensive quantitative method which is sensitive enough to evaluate the neuromuscular functions. The present project will evaluate the laryngeal nerve function by quantitative laryngeal electromyography, which was developed by the research team, and another novel examination technique, mucosal membrane sensation test. The comprehensive method is expected to grade the laryngeal nerve injuries quantitatively before the significant symptoms or complications and can also help to evaluate the treatment effect from medicine, rehabilitation or surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with laryngopharyngeal or esophageal cancer who have taken active therapy and are not neck tissue damage.
  • Patients with clear conscious and stable mental status

排除标准

  • Patients who cannot sit for longer than 30 minutes or received other vocal cord treatments before the selection
  • Pregnant and breastfeeding women
  • Patients with communication disorder

结局指标

主要结局

Fiberoptic endoscopic evaluation of swallowing (FEES)

时间窗: Baseline:Within 3-6 months after synptom occurs

Swallowing evaluation

Laryngo-pharyngeal mucosa sensation test

时间窗: Baseline:Within 3-6 months after synptom occurs

There were four probes of different diameters that similar to the Von Frey filament were prepared for the examination. The diameters were 0.07mm, 0.15mm.0.2 mm and 0.3 mm. The mono-filament nylon probe was placed and contact with the tip and arytenoid mucosa.

次要结局

  • laryngeal electromyography(Baseline:Within 3-6 months after synptom occurs)
  • Disease related life quality assessment: FACT-H&N, FACT-E(Baseline:Within 3-6 months after synptom occurs)
  • Voice Handicap Index (VHI)(Baseline:Within 3-6 months after synptom occurs)
  • laboratory voice analysis(Baseline:Within 3-6 months after synptom occurs)
  • voice range profile(Baseline:Within 3-6 months after synptom occurs)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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