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

NCT05149976 | Recruiting

• 1 other identifier: B-2109-707-303
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1

Secondary Outcomes (7)

• mAP (mean Average Precision) of machine learning prediction model using voice change before and after dietary intake

  day 1

• Recall of machine learning prediction model using voice change before and after dietary intake.

  day 1

• AUC (Area Under the ROC curve) of machine learning prediction model using voice change before and after dietary intake.

  day 1

• Accuracy of machine learning prediction model using only voice after dietary intake.

  day 1

• mAP (mean Average Precision) of machine learning prediction model using only voice after dietary intake.

  day 1

Study Arms (3)

Normal group

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

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

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

Diagnostic Test: Voice recording before and after dietary intake

Interventions

Voice recording before and after dietary intake 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; Normal group; Residue Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

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

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 39157445 DERIVED

• 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.

  PMID: 38555417 DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Juseok Ryu, M.D. PhD

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Central Study Contacts

Juseok Ryu, M.D. PhD

CONTACT

+82-31-787-7739; jseok337@snu.ac.kr

sunyoung Choi, M.D

CONTACT

+82-5374-6130; 0_1235@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: December 8, 2021
• Study Start: October 7, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

KR (1)