跳至主要内容
临床试验/NCT02718963
NCT02718963已完成不适用

Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2015年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.

研究概览

简要总结

The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

详细描述

  • Design: Prospective study
  • Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10)
  • Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10)
  • Setting: Hospital rehabilitation department
  • Intervention: Participants are applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study

排除标准

  • who reject the checkup their deglutition function by high resolution manometry
  • who reject apply "Synchronized Electrical Stimulator"

结局指标

主要结局

Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.

时间窗: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter

Maximal pressure, integral, rise time, and duration in the regions of VP and TB (the time interval over the VP and TB integral). The maximal pressure of low pharynx (LP) (C in supplementary 1), maximal pre-upper esophageal sphincter (UES) pressure (F in supplementary 1), maximal cricopharyngeus (CP) pressure (D in supplementary 1), minimal upper esophageal sphincter (UES) pressure, upper esophageal sphincter (UES) activity time (the interval between pre-upper esophageal sphincter (UES) peak and post-upper esophageal sphincter (UES) peak; G in supplementary 1), and nadir upper esophageal sphincter (UES) pressure duration in the region of upper esophageal sphincter (UES).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ju Seok Ryu

associate professor

Seoul National University Hospital

研究点 (2)

Loading locations...

相似试验

Treatment of Dysphagia by Using a Synchronized... | 临床试验