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

April 18, 2024 updated by: Ju Seok Ryu, Seoul National University Hospital
Collection of basic data to develop a technique for monitoring the state of dysphagia using voice analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
  • 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
Diagnostic test: 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.
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
  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mAP (mean Average Precision) of machine learning prediction model using voice change before and after dietary intake
Time Frame: day 1
mAP measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.
day 1
Recall of machine learning prediction model using voice change before and after dietary intake.
Time Frame: day 1
Recall measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes 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.
Time Frame: day 1
AUC measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice changes before and after dietary intake.
day 1
Accuracy of machine learning prediction model using only voice after dietary intake.
Time Frame: day 1
Accuracy measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.
day 1
mAP (mean Average Precision) of machine learning prediction model using only voice after dietary intake.
Time Frame: day 1
mAP measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.
day 1
Recall of machine learning prediction model using only voice after dietary intake.
Time Frame: day 1
Recall measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.
day 1
AUC (Area Under the ROC curve) of machine learning prediction model using only voice after dietary intake.
Time Frame: day 1
AUC measures how well machine learning predicts three groups ('Normal', 'Residue', 'Aspiration') according to voice only voice after dietary intake.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Juseok Ryu, M.D. PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-2109-707-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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