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