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Clinical Trials/NCT05149976
NCT05149976
Recruiting
Not Applicable

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

Seoul National University Hospital1 site in 1 country300 target enrollmentOctober 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deglutition Disorders
Sponsor
Seoul National University Hospital
Enrollment
300
Locations
1
Primary Endpoint
Accuracy of machine learning prediction model using voice change before and after dietary intake
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

* 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.

Registry
clinicaltrials.gov
Start Date
October 7, 2021
End Date
December 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ju Seok Ryu

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: day 1

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

Secondary Outcomes

  • 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)

Study Sites (1)

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