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.

NCT ID: NCT05439447

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 246 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-07
• Study Completion Date: 2024-12-18

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.

Detailed Description

• Design : Prospective cohort study
• Setting : Hospital rehabilitation department
• Inclusion criteria of the patient group : Patients scheduled for VFSS examination
• Intervention

• This study will be conducted after collecting basic information such as age, gender, and disease of patients who met the inclusion criteria among patients scheduled to undergo a video fluoroscopic swallowing test (VFSS test) for the diagnosis of dysphagia, and after obtaining guidance and consent through the study description will do.
• Before the subject's VFSS test, "Ah for 5 seconds", after clearing the throat, "Ah for 5 seconds", and briefly cut with a slightly high sound, "Ah. oh Ah.", shut lips lightly and read "Ummm~~~~", read a short sentence.
• While the subject makes the above sound, voice is recorded, video is taken, and integrated sensors such as a microphone (sound detection) sensor and surface electromyography sensor are attached to measure changes in each sensor.
• After the VFSS test, participants will repeat the above sound and record the same twice. (As before the test, imaging of the patient's swallowing is also performed.)
• Using voice analysis, various sensor values, and image information, a voice indicator that can predict the amount of suction and residue on the VFSS test is found.

Conditions

Deglutition Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients scheduled for VFSS examination due to dysphagia.

Patients scheduled for VFSS testing group

Intervention Type: DIAGNOSTIC_TEST

Patients scheduled for VFSS testing, patient with voice.

Interventions

Patients scheduled for VFSS testing group

Patients scheduled for VFSS testing, patient with voice.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ju Seok Ryu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juseok Ryu, M.D, PhD

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

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

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-2206-761-302

Identifier Type: -

Identifier Source: org_study_id