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OpenTrials
Completed

NCT Number: NCT05098808

Artificial Intelligence in Diagnosing Dysphagia Patients

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.

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Key information

About this study

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.

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • Participants who were unable to perform phonation
  • Participants who had no VFSS or standardized swallowing assessment results
  • Participants with no spirometric measurements

Treatment and study plan

Acoustic features (from signals obtained during phonation)

Other

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

Primary outcomes

  1. Functional Oral Intake Scale

    Time frame: during the intervention

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

  2. Cough strength

    Time frame: during the intervention

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

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Classification of Dysphagia Patients at Risk of Aspiration Pneumonia Using Machine Learning Algorithms Incorporating Acoustic Features From Phonetic Evaluation

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2021
Registry last updated
Oct 28, 2021

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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