Deglutition DisordersNCT05439447
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 of Deglutition Disorders, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- Voice recording and sensor-based data collection
- How many people
- 259 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Apr 2023to 18 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for VFSS examination due to dysphagia
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, 463-707
About this study
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
- Deglutition Disorders
- Being tested
- Voice recording and sensor-based data collection
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice recording and sensor-based data collectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Group | Healthy volunteers and VFSS patients with PAS 1. Voice recorded before and after swallowing. Receives: 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. Receives: 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. Receives: Diagnostic Test: Voice recording and sensor-based data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline/ Change from baseline when swallowing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start7 Apr 2023
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seok Ryu, Seoul National University Bundang Hospital
- Investigators
- Juseok Ryu, M.D, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439447
- Sponsor's protocol ID
- B-2206-761-302
- Status last verified
- Feb 2026
- First submitted
- 16 Jun 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data contain voice recordings which are personally identifiable. Sharing is restricted under Korean Personal Information Protection Act and institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05439447
- Acronym / sponsor ID
- B-2206-761-302
- Conditions
- Deglutition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Group | – | Diagnostic Test: Voice recording and sensor-based data collectionHealthy volunteers and VFSS patients with PAS 1. Voice recorded before and after swallowing. |
| Low-Risk Dysphagia Group (Penetration/Residue) | – | Diagnostic Test: Voice recording and sensor-based data collectionVFSS patients with PAS 2-4. Voice recorded before and after VFSS examination. |
| High-Risk Dysphagia Group (Aspiration) | – | Diagnostic Test: Voice recording and sensor-based data collectionVFSS patients with PAS 5-8. Voice recorded before and after VFSS examination. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for VFSS examination due to dysphagia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice recording and sensor-based data collectionPre- 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. | Diagnostic test | High-Risk Dysphagia Group (Aspiration), Low-Risk Dysphagia Group (Penetration/Residue), Normal Group |
Primary outcome
Voice analysis before and after meals, the results are compared with VFSS to verify significant indicators (residue, aspiration, etc.) by Paired t-test analysis.
Time frame: Baseline/ Change from baseline when swallowing
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data contain voice recordings which are personally identifiable. Sharing is restricted under Korean Personal Information Protection Act and institutional policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juseok Ryu, M.D, PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice analysis before and after meals, the results are compared with VFSS to verify significant indicators (residue, aspiration, etc.) by Paired t-test analysis. (time frame: Baseline/ Change from baseline when swallowing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.