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.

Deglutition Disorders Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439447
• Other study ID #: B-2206-761-302
• Status: Recruiting
• Start date: October 7, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Juseok Ryu, M.D, PhD
• Phone: +82-31-787-7739
• Email: jseok337[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Those who are 19 years of age or older and do not fall under the 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

Diagnostic Test:
• Patients scheduled for VFSS testing group
Patients scheduled for VFSS testing, patient with voice.

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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