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

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

Study Overview

• Status: Recruiting
• Conditions: Deglutition Disorders
• Intervention / Treatment: Diagnostic test: Voice recording before and after dietary intake

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.

• Study Type: Observational
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juseok Ryu, M.D. PhD; Phone Number: +82-31-787-7739; Email: jseok337@snu.ac.kr
• Study Contact Backup: Name: sunyoung Choi, M.D; Phone Number: +82-5374-6130; Email: 0_1235@naver.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
      • Contact: Sunyoung Choi, CRA; Phone Number: +82-5374-6130; Email: 0_1235@naver.com
      • Contact: Juseok Ryu, M.D, PhD; Phone Number: +82-31-787-7739; Email: jseok337@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• Normal Group

  1. Among those scheduled for VFSS due to symptoms of dysphagia, patients whose reading result was judged normal
  2. General subjects without signs or symptoms of dysphagia

• Residue Group

  1) Among those scheduled for VFSS examination due to symptoms of dysphagia, patients who had residues left in the pharynx or airway as a result of reading

• Aspiration

  1) Among those scheduled for VFSS examination due to symptoms of dysphagia, aspiration occurred in the airway as a result of reading

• No limiting criteria for age and underlying disease were established in all groups.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal group; A person judged normal among VFSS (video fluoroscopic swallowing study) examiners; Normal subjects without symptoms of dysphagia	Diagnostic test: Voice recording before and after dietary intake; A person who is scheduled to undergo a VFSS test, and his/her voice is recorded before and after eating for the VFSS test; For general subjects, only voice recordings were conducted before and after food/water intake without a VFSS test.
Residue Group; - As a result of VFSS (video fluoroscopic swallowing study), the subjects who have residues left around the pharynx or airway	Diagnostic test: Voice recording before and after dietary intake; A person who is scheduled to undergo a VFSS test, and his/her voice is recorded before and after eating for the VFSS test; For general subjects, only voice recordings were conducted before and after food/water intake without a VFSS test.
Aspiration Group; - VFSS (video fluoroscopic swallowing study) test result, the subjects who have aspiration in the airway	Diagnostic test: Voice recording before and after dietary intake; A person who is scheduled to undergo a VFSS test, and his/her voice is recorded before and after eating for the VFSS test; For general subjects, only voice recordings were conducted before and after food/water intake without a VFSS test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of machine learning prediction model using voice change before and after dietary intake	Accuracy measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mAP (mean Average Precision) of machine learning prediction model using voice change before and after dietary intake	mAP measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.	day 1
Recall of machine learning prediction model using voice change before and after dietary intake.	Recall measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.	day 1
AUC (Area Under the ROC curve) of machine learning prediction model using voice change before and after dietary intake.	AUC measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.	day 1
Accuracy of machine learning prediction model using only voice after dietary intake.	Accuracy measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.	day 1
mAP (mean Average Precision) of machine learning prediction model using only voice after dietary intake.	mAP measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.	day 1
Recall of machine learning prediction model using only voice after dietary intake.	Recall measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.	day 1
AUC (Area Under the ROC curve) of machine learning prediction model using only voice after dietary intake.	AUC measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.	day 1

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Juseok Ryu, M.D. PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: B-2109-707-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No