Clinical trial NCT05149976: Establishment of Voice Analysis Cohort for Development of Monitoring Technology for Dysphagia
Official title: Establishment of Voice Analysis Cohort for Development of Monitoring Technology for Dysphagia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deglutition Disorders
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of machine learning prediction model using voice change before and after dietary intake
timeFrame: day 1
Secondary outcomes:
measure: mAP (mean Average Precision) of machine learning prediction model using voice change before and after dietary intake
timeFrame: day 1
measure: Recall of machine learning prediction model using voice change before and after dietary intake.
timeFrame: day 1
measure: AUC (Area Under the ROC curve) of machine learning prediction model using voice change before and after dietary intake.
timeFrame: day 1
measure: Accuracy of machine learning prediction model using only voice after dietary intake.
timeFrame: day 1
measure: mAP (mean Average Precision) of machine learning prediction model using only voice after dietary intake.
timeFrame: day 1
measure: Recall of machine learning prediction model using only voice after dietary intake.
timeFrame: day 1
measure: AUC (Area Under the ROC curve) of machine learning prediction model using only voice after dietary intake.
timeFrame: day 1
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Juseok Ryu, M.D. PhD
role: STUDY_DIRECTOR
References: