Voice Analysis Using the LPC (Linear Predictive Coding)Method for the Prediction of Aspiration;Prospective, Positive-controlled, Single-blind, Single Cohort Clinical Study of Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- LPC index
研究概览
简要总结
It was well known that aspiration is the primary cause of an aspiration pneumonia among the dysphagia patients.
In order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are invasive and allowed only in a limited condition.
In this study, as a precedent study for the non-linear analysis, voice analysis using LPC method will be evaluated. The superiority of LPC method will be compared with a spectral analysis using Jitter and Simmer as a positive control.
This clinical study will be performed prospective, positive-controlled, single-blind (i.e. assessor-blind),and single cohort clinical trial for efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were referred for VFSS
排除标准
- •Patients cannot phonate d/t tracheostomy
- •Preexisting oro-laryngo-pharyngeal disease
- •Patients cannot follow 1 step command
- •Patients cannot maintain a phonation for 3 seconds
- •Refusal of participation
- •Patients who were not classified for the candidate by physicians
- •Patients who coughs following drinking of 5ml normal saline
结局指标
主要结局
LPC index
时间窗: one day before or after VFFS
Voice sampling before and immediately after drinking of 20ml N/S and linear analysis using LPC method
次要结局
- Spectral Analysis(one day before or after VFFS)
- LPC anaysis(one day after or before VFSS)
- Risk group(whithin one hour of VFSS)
研究者
Chang Ho Hwang
Associate Professor
Ulsan University Hospital