A Study on Building a Voice Cohort for the Development of a Non-face-to-face Machine Learning Diagnostic and Monitoring Platform Using Voice Analysis and Various Sensors in Patients With Dysphagia.

NCT05439447 | Completed

• 1 other identifier: B-2206-761-302
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

Collection of basic data for real-time analysis and monitoring by measuring what changes in voice occur according to the state of dysphagia using voice analysis and various sensors.

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

• Voice analysis before and after meals, the results are compared with VFSS to verify significant indicators (residue, aspiration, etc.) by Paired t-test analysis.

  By comparing the VFSS swallow test result with the analysis value through voice analysis, the accuracy of the case classified as aspiration in the voice test is used as the primary indicator.

  Baseline/ Change from baseline when swallowing

Study Arms (3)

Normal Group

Healthy volunteers and VFSS patients with PAS 1. Voice recorded before and after swallowing.

Diagnostic Test: Voice recording and sensor-based data collection

Low-Risk Dysphagia Group (Penetration/Residue)

VFSS patients with PAS 2-4. Voice recorded before and after VFSS examination.

Diagnostic Test: Voice recording and sensor-based data collection

High-Risk Dysphagia Group (Aspiration)

VFSS patients with PAS 5-8. Voice recorded before and after VFSS examination.

Diagnostic Test: Voice recording and sensor-based data collection

Interventions

Voice recording and sensor-based data collection DIAGNOSTIC_TEST

Pre- and post-swallowing voice recordings (sustained phonation "ah" for 5 seconds, short phonation, humming, and sentence reading) were collected using a microphone (AKG C 411L) attached to suprahyoid muscles. For VFSS patients, recordings were performed before and after VFSS examination. For healthy controls, recordings were performed before and after yogurt intake. No therapeutic intervention was performed.

High-Risk Dysphagia Group (Aspiration); Low-Risk Dysphagia Group (Penetration/Residue); Normal Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for VFSS examination due to dysphagia

You may not qualify if:

• Patients scheduled for VFSS test
• Patients who can record voices such as "Ah.", "Ummm\~\~\~", short sentences
• Patients who can attach sensor on their throat
• Those who voluntarily consent to the clinical trial
• Those who do not agree to participate in this study
• Patients who can not follow Step 1 instructions
• Patients who can not vocalize or follow to speak
• Patients who cannot apply the sensor due to skin allergy or hypersensitivity to sensor attachment
• Other who have comorbidities (e.g., maligant tumors, blood clotting abnormalities, etc.) that are inappropriate for clinical trial participation by the judgment of the researcher 6) Other who are judged by the researcher to be unsuitable for this clinical trial.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Juseok Ryu, M.D, PhD

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 30, 2022
• Study Start: April 7, 2023
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)