Deglutition DisordersNCT05149976
Establishment of Voice Analysis Cohort for Development of Monitoring Technology for 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 to develop a technique for monitoring the state of dysphagia using voice analysis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- Voice recording before and after dietary intake
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2021to Dec 2024
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Normal Group 1. Among those scheduled for VFSS due to symptoms of dysphagia, patients whose reading result was judged normal 2. General subjects without signs or symptoms of dysphagia * Residue Group 1) Among those scheduled for VFSS examination due to symptoms of dysphagia, patients who had residues left in the pharynx or airway as a result of reading * Aspiration 1) Among those scheduled for VFSS examination due to symptoms of dysphagia, aspiration occurred in the airway as a result of reading * No limiting criteria for age and underlying disease were established in all groups.
Who may be able to join
- Patients with dysphagia and scheduled for VFSS testing
- Patients who can record voice such as "Ah for 5 seconds", "Ah. ah. ah", or "Um~~"
- Normal people (without dysphagia symptoms) who can record voice (additionally recruited for comparison of voice indicators with patients with dysphagia)
Who cannot join
- Patients who cannot speak.
- Patients who cannot speak according to the researcher's instructions.
- Patients whose VFSS test was reexamined
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, 463-707
Juseok Ryu, M.D, PhD, +82-31-787-7739, jseok337@snu.ac.kr
sunyoung Choi, CRA, +82-5374-6130, 0_1235@naver.com
About this study
Collection of basic data to develop a technique for monitoring the state of dysphagia using voice analysis.
Read the detailed description
- Design: Prospective study
- Inclusion criteria of the patient group
- Patients scheduled for VFSS examination and normal person (without dysphagia) capable of recording voice (selected as a control group for comparison of voice indicators with patients with dysphagia)
- Patients who can record voices such as "Ah for 5 seconds", "Ah. Ah. Ah.", "umm~~~"
- Inclusion criteria of the control group: Patients unable to speak, Patients who cannot follow along, If the VFSS test is a retest
- Setting: Hospital rehabilitation department
- Intervention: After obtaining the consent form for the patient scheduled for the VFSS test, "Ah for 5 seconds", after clearing the throat, "Ah for 5 seconds", briefly cut with a high-pitched sound, "Ah. Ah. Ah", close your lips lightly and make a "ummm~~~~" sound, and record 2 times each.
- Conditions
- Deglutition Disorders
- Being tested
- Voice recording before and after dietary intake
- 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 before and after dietary intakeDiagnostic test
- A person who is scheduled to undergo a VFSS test, and his/her voice is recorded before and after eating for the VFSS test
- For general subjects, only voice recordings were conducted before and after food/water intake without a VFSS test.
| Study group | Role | What they receive |
|---|---|---|
| Normal group | * A person judged normal among VFSS (video fluoroscopic swallowing study) examiners
* Normal subjects without symptoms of dysphagia Receives: Diagnostic Test: Voice recording before and after dietary intake | |
| Residue Group | - As a result of VFSS (video fluoroscopic swallowing study), the subjects who have residues left around the pharynx or airway Receives: Diagnostic Test: Voice recording before and after dietary intake | |
| Aspiration Group | - VFSS (video fluoroscopic swallowing study) test result, the subjects who have aspiration in the airway Receives: Diagnostic Test: Voice recording before and after dietary intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of machine learning prediction model using voice change before and after dietary intake
Accuracy measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.
Measured: day 1
Secondary outcomes (7)
mAP (mean Average Precision) of machine learning prediction model using voice change before and after dietary intake
mAP measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.
Measured: day 1
Recall of machine learning prediction model using voice change before and after dietary intake.
Recall measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.
Measured: day 1
AUC (Area Under the ROC curve) of machine learning prediction model using voice change before and after dietary intake.
AUC measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.
Measured: day 1
Accuracy of machine learning prediction model using only voice after dietary intake.
Accuracy measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.
Measured: day 1
mAP (mean Average Precision) of machine learning prediction model using only voice after dietary intake.
mAP measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.
Measured: day 1
Recall of machine learning prediction model using only voice after dietary intake.
Recall measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.
Measured: day 1
AUC (Area Under the ROC curve) of machine learning prediction model using only voice after dietary intake.
AUC measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start7 Oct 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 300 participants (estimated)
- Target duration
- 1 Day
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 Hospital
- Investigators
- Juseok Ryu, M.D. PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149976
- Sponsor's protocol ID
- B-2109-707-303
- Status last verified
- Apr 2024
- First submitted
- 1 Nov 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim JM, Kim MS, Choi SY, Kim HJ, Ryu JS. Post-swallowing voice-based aspiration screening in dysphagia using a deep learning approach: insights from audio segmentation. Sci Rep. 2026 May 21;16(1):23160. doi: 10.1038/s41598-026-53618-w.
PubMed 42168445Kim JM, Kim MS, Choi SY, Lee K, Ryu JS. A deep learning approach to dysphagia-aspiration detecting algorithm through pre- and post-swallowing voice changes. Front Bioeng Biotechnol. 2024 Aug 2;12:1433087. doi: 10.3389/fbioe.2024.1433087. eCollection 2024.
PubMed 39157445Kim JM, Kim MS, Choi SY, Ryu JS. Prediction of dysphagia aspiration through machine learning-based analysis of patients' postprandial voices. J Neuroeng Rehabil. 2024 Mar 30;21(1):43. doi: 10.1186/s12984-024-01329-6.
PubMed 38555417
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Voice Analysis Cohort for Development of Monitoring Technology for Dysphagia
- ClinicalTrials.gov ID
- NCT05149976
- Acronym / sponsor ID
- B-2109-707-303
- Conditions
- Deglutition Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Dec 2021 (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 to develop a technique for monitoring the state of dysphagia using voice analysis.
Detailed description
- Design: Prospective study
- Inclusion criteria of the patient group
- Patients scheduled for VFSS examination and normal person (without dysphagia) capable of recording voice (selected as a control group for comparison of voice indicators with patients with dysphagia)
- Patients who can record voices such as "Ah for 5 seconds", "Ah. Ah. Ah.", "umm~~~"
- Inclusion criteria of the control group: Patients unable to speak, Patients who cannot follow along, If the VFSS test is a retest
- Setting: Hospital rehabilitation department
- Intervention: After obtaining the consent form for the patient scheduled for the VFSS test, "Ah for 5 seconds", after clearing the throat, "Ah for 5 seconds", briefly cut with a high-pitched sound, "Ah. Ah. Ah", close your lips lightly and make a "ummm~~~~" sound, and record 2 times each.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | Diagnostic Test: Voice recording before and after dietary intake* A person judged normal among VFSS (video fluoroscopic swallowing study) examiners * Normal subjects without symptoms of dysphagia |
| Residue Group | – | Diagnostic Test: Voice recording before and after dietary intake- As a result of VFSS (video fluoroscopic swallowing study), the subjects who have residues left around the pharynx or airway |
| Aspiration Group | – | Diagnostic Test: Voice recording before and after dietary intake- VFSS (video fluoroscopic swallowing study) test result, the subjects who have aspiration in the airway |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Normal Group 1. Among those scheduled for VFSS due to symptoms of dysphagia, patients whose reading result was judged normal 2. General subjects without signs or symptoms of dysphagia * Residue Group 1) Among those scheduled for VFSS examination due to symptoms of dysphagia, patients who had residues left in the pharynx or airway as a result of reading * Aspiration 1) Among those scheduled for VFSS examination due to symptoms of dysphagia, aspiration occurred in the airway as a result of reading * No limiting criteria for age and underlying disease were established in all groups.
Key inclusion criteria (3 listed)
- Patients with dysphagia and scheduled for VFSS testing
- Patients who can record voice such as "Ah for 5 seconds", "Ah. ah. ah", or "Um~~"
- Normal people (without dysphagia symptoms) who can record voice (additionally recruited for comparison of voice indicators with patients with dysphagia)
Key exclusion criteria (3 listed)
- Patients who cannot speak.
- Patients who cannot speak according to the researcher's instructions.
- Patients whose VFSS test was reexamined
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 before and after dietary intake* A person who is scheduled to undergo a VFSS test, and his/her voice is recorded before and after eating for the VFSS test * For general subjects, only voice recordings were conducted before and after food/water intake without a VFSS test. | Diagnostic test | Aspiration Group, Normal group, Residue Group |
Primary outcome
Accuracy of machine learning prediction model using voice change before and after dietary intake
Time frame: day 1
Accuracy measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.
7 secondary outcomes
mAP (mean Average Precision) of machine learning prediction model using voice change before and after dietary intake
Time frame: day 1
Recall of machine learning prediction model using voice change before and after dietary intake.
Time frame: day 1
AUC (Area Under the ROC curve) of machine learning prediction model using voice change before and after dietary intake.
Time frame: day 1
Accuracy of machine learning prediction model using only voice after dietary intake.
Time frame: day 1
mAP (mean Average Precision) of machine learning prediction model using only voice after dietary intake.
Time frame: day 1
Recall of machine learning prediction model using only voice after dietary intake.
Time frame: day 1
AUC (Area Under the ROC curve) of machine learning prediction model using only voice after dietary intake.
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 42168445Kim JM, Kim MS, Choi SY, Kim HJ, Ryu JS. Post-swallowing voice-based aspiration screening in dysphagia using a deep learning approach: insights from audio segmentation. Sci Rep. 2026 May 21;16(1):23160. doi: 10.1038/s41598-026-53618-w.
- Derived from this study: PubMed 39157445Kim JM, Kim MS, Choi SY, Lee K, Ryu JS. A deep learning approach to dysphagia-aspiration detecting algorithm through pre- and post-swallowing voice changes. Front Bioeng Biotechnol. 2024 Aug 2;12:1433087. doi: 10.3389/fbioe.2024.1433087. eCollection 2024.
- Derived from this study: PubMed 38555417Kim JM, Kim MS, Choi SY, Ryu JS. Prediction of dysphagia aspiration through machine learning-based analysis of patients' postprandial voices. J Neuroeng Rehabil. 2024 Mar 30;21(1):43. doi: 10.1186/s12984-024-01329-6.
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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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juseok Ryu, M.D. PhD (+82-31-787-7739, jseok337@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of machine learning prediction model using voice change before and after dietary intake (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149976, which also lists 3 linked publications.
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 19 Apr 2024.