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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.

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05439447
Enrollment
259
Registered
2022-06-30
Start date
2023-04-07
Completion date
2024-12-18
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deglutition Disorders

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 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.

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Voice analysis before and after meals, the results are compared with VFSS to verify significant indicators (residue, aspiration, etc.) by Paired t-test analysis.Baseline/ Change from baseline when swallowingBy 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.

Countries

South Korea

Contacts

STUDY_DIRECTORJuseok Ryu, M.D, PhD

Seoul National University Bundang Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026