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CompletedNCT05098808Updated Oct 28, 2021

Artificial Intelligence in Diagnosing Dysphagia Patients

An observational study in Respiration Disorders, Swallowing Disorder and Phonation Disorder, sponsored by The Catholic University of Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by The Catholic University of Korea · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
449
Ages
19 Years to 90 Years
Sex
All
01

Study summary

In this prospective study we extracted acoustic parameters using PRAAT from patient's attempt to phonate during the clinical evaluation using a digital smart device. From these parameters we attempted (1) to define which of the PRAAT acoustic features best help to discriminate patients with dysphagia (2) to develop algorithms using sophisticated ML techniques that best classify those i) with dysphagia and those ii ) at high risk of respiratory complications due to poor cough force.

Read the detailed description

This study was prospective study, and patients who visited the department of rehabilitation medicine in a single university-affiliated tertiary hospital with dysphagic symptoms from September 2019 to March 2021 were included.Voice recording was performed at the enrollment with blinded assessment, where the participants first visited the rehabilitation department with chief complaints of dysphagia. The cough sounds were recorded with an iPad (Apple, Cupertino, CA, USA) through an embedded microphone.

From the acoustic files we extracted fourteen voice parameters that include the average value and standard deviation of the fundamental frequency (f0), harmonic-to-noise ratio (HNR), the jitter that refers to frequency instability, and the shimmer that represents the amplitude instability of the sound signal.

Machine learning algorithms and sophisticated deep neural network analysis will be performed.

02

Conditions studied

  • Respiration Disorders
  • Swallowing Disorder
  • Phonation Disorder
  • Stroke
  • Aspiration Pneumonia
  • Aspiration; Liquids
03

Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

First ever stroke patients referred for swallowing disorders

Eligibility criteria

Inclusion Criteria:

  • Inclusion criteria
  1. Suspected swallowing disorder who were referred for swallowing assessment
  2. Dysphagia attributable to brain lesion including stroke

Exclusion Criteria:

  1. Participants who were unable to perform phonation
  2. Participants who had no VFSS or standardized swallowing assessment results
  3. Participants with no spirometric measurements
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
449 participants (actual)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • Dysphagia mild

    Able to start oral feeding after assessment

    Other: Acoustic features (from signals obtained during phonation)

  • Dysphagia severe

    Non oral feeding and high risk of aspiration

    Other: Acoustic features (from signals obtained during phonation)

Interventions

  • OtherAcoustic features (from signals obtained during phonation)

    Acoustic features will be obtained via phonation files. A voice recorder application provided by Apple was used, and the sampling frequency of the sound was 44,100 Hz. The digitized cough sound signals were band-pass-filtered between 20 to 16,000 Hz to use data from the whole frequency band gathered by the iPad. In each case, the smart device was positioned 20cm from the patient

05

What researchers measure

Primary outcomes

  1. Functional Oral Intake Scale

    Dysphagia severity as measured by the the Functional Oral Intake Scale obtained from standardized swallowing tests

    Time frame: during the intervention

  2. Cough strength

    Spirometry values : cough strength as measured by the spirometric values during voluntary cough

    Time frame: during the intervention

06

Study locations

1 site
  • Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
    Bucheon, Kyounggido, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No — Data would be accessible only upon formal request to the formal PI

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05098808
Lead sponsor
The Catholic University of Korea
Responsible party
Sun Im (associate professor, The Catholic University of Korea) — Principal investigator
First posted
Oct 28, 2021
Start date
Sep 1, 2019
Primary completion
Sep 1, 2021
Completion
Oct 1, 2021
Last update
Oct 28, 2021

Study contacts

Sun Im, MD PhD
principal investigator · The Catholic University of Korea

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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