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临床试验/NCT05149976
NCT05149976招募中不适用

Establishment of Voice Analysis Cohort for Development of Monitoring Technology for Dysphagia

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Accuracy of machine learning prediction model using voice change before and after dietary intake

研究概览

简要总结

Collection of basic data to develop a technique for monitoring the state of dysphagia using voice analysis.

详细描述

  • Design: Prospective study

  • Inclusion criteria of the patient group

  • Patients scheduled for VFSS examination and normal person (without dysphagia) capable of recording voice (selected as a control group for comparison of voice indicators with patients with dysphagia)

  • Patients who can record voices such as "Ah for 5 seconds", "Ah. Ah. Ah.", "umm~~~"

  • Inclusion criteria of the control group: Patients unable to speak, Patients who cannot follow along, If the VFSS test is a retest

  • Setting: Hospital rehabilitation department

  • Intervention: After obtaining the consent form for the patient scheduled for the VFSS test, "Ah for 5 seconds", after clearing the throat, "Ah for 5 seconds", briefly cut with a high-pitched sound, "Ah. Ah. Ah", close your lips lightly and make a "ummm~~~~" sound, and record 2 times each.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with dysphagia and scheduled for VFSS testing
  • Patients who can record voice such as "Ah for 5 seconds", "Ah. ah. ah", or "Um~~"
  • Normal people (without dysphagia symptoms) who can record voice (additionally recruited for comparison of voice indicators with patients with dysphagia)

排除标准

  • Patients who cannot speak.
  • Patients who cannot speak according to the researcher's instructions.
  • Patients whose VFSS test was reexamined

结局指标

主要结局

Accuracy of machine learning prediction model using voice change before and after dietary intake

时间窗: day 1

Accuracy measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.

次要结局

  • AUC (Area Under the ROC curve) of machine learning prediction model using voice change before and after dietary intake.(day 1)
  • mAP (mean Average Precision) of machine learning prediction model using voice change before and after dietary intake(day 1)
  • Recall of machine learning prediction model using voice change before and after dietary intake.(day 1)
  • Accuracy of machine learning prediction model using only voice after dietary intake.(day 1)
  • mAP (mean Average Precision) of machine learning prediction model using only voice after dietary intake.(day 1)
  • AUC (Area Under the ROC curve) of machine learning prediction model using only voice after dietary intake.(day 1)
  • Recall of machine learning prediction model using only voice after dietary intake.(day 1)

研究者

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

Ju Seok Ryu

Professor

Seoul National University Hospital

研究点 (1)

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