CompletedNCT05439447Updated Feb 25, 2026

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.

An observational study in Deglutition Disorders, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Seoul National University Hospital · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 259
Ages: 19 Years and older
Sex: All

Study 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.

Read the 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 is 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 studied

Deglutition Disorders

Browse trials for

Deglutition Disorders 710

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 259 is above the median of 97 across 207 observational studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

Patients scheduled for VFSS examination due to dysphagia

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

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 259 participants (actual)
Patient registry: No

Groups and cohorts

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

Diagnostic testVoice recording and sensor-based data collection
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.

What researchers measure

Primary outcomes

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.
Time frame: Baseline/ Change from baseline when swallowing

Study locations

1 site

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do 463-707, South Korea

References and documents

Individual participant data

Plan to share: No — Individual participant data contain voice recordings which are personally identifiable. Sharing is restricted under Korean Personal Information Protection Act and institutional policy.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05439447
Lead sponsor: Seoul National University Hospital
Responsible party: Ju Seok Ryu (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted: Jun 30, 2022
Start date: Apr 7, 2023
Primary completion: Dec 18, 2024
Completion: Dec 18, 2024
Last update: Feb 25, 2026

Study contacts

Juseok Ryu, M.D, PhD

study director · Seoul National University Bundang Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Deglutition Disorders→

Other studies from this sponsor

Seoul National University Hospital

Start the discussion