Establishment of Voice Analysis Cohort for Development of Monitoring Technology for Dysphagia

NCT ID: NCT05149976

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-07

Study Completion Date

2024-12-31

Brief Summary

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Collection of basic data to develop a technique for monitoring the state of dysphagia using voice analysis.

Detailed Description

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* 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

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Deglutition Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal group

* A person judged normal among VFSS (video fluoroscopic swallowing study) examiners
* Normal subjects without symptoms of dysphagia

Voice recording before and after dietary intake

Intervention Type DIAGNOSTIC_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.

Residue Group

\- As a result of VFSS (video fluoroscopic swallowing study), the subjects who have residues left around the pharynx or airway

Voice recording before and after dietary intake

Intervention Type DIAGNOSTIC_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.

Aspiration Group

\- VFSS (video fluoroscopic swallowing study) test result, the subjects who have aspiration in the airway

Voice recording before and after dietary intake

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Patients who cannot speak.
* Patients who cannot speak according to the researcher's instructions.
* Patients whose VFSS test was reexamined
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju Seok Ryu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juseok Ryu, M.D. PhD

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

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Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Juseok Ryu, M.D. PhD

Role: CONTACT

+82-31-787-7739

sunyoung Choi, M.D

Role: CONTACT

+82-5374-6130

Facility Contacts

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Juseok Ryu, M.D, PhD

Role: primary

+82-31-787-7739

sunyoung Choi, CRA

Role: backup

+82-5374-6130

References

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Kim 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.

Reference Type DERIVED
PMID: 39157445 (View on PubMed)

Kim 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.

Reference Type DERIVED
PMID: 38555417 (View on PubMed)

Other Identifiers

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B-2109-707-303

Identifier Type: -

Identifier Source: org_study_id

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