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Completed

NCT Number: NCT05439447

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.

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Those who do not agree to participate in this study
  • Patients who can not follow Step 1 instructions
  • Patients who can not vocalize or follow to speak
  • Patients who cannot apply the sensor due to skin allergy or hypersensitivity to sensor attachment
  • Other who have comorbidities (e.g., maligant tumors, blood clotting abnormalities, etc.) that are inappropriate for clinical trial participation by the judgment of the researcher 6) Other who are judged by the researcher to be unsuitable for this clinical trial.

Treatment and study plan

Voice recording and sensor-based data collection

Diagnostic Test

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.

Primary outcomes

  1. Voice analysis before and after meals, the results are compared with VFSS to verify significant indicators (residue, aspiration, etc.) by Paired t-test analysis.

    Time frame: Baseline/ Change from baseline when swallowing

    By 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2022
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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