Artificial Intelligence in Diagnosing Dysphagia Patients

NCT05098808 | Completed DMC

• 1 other identifier: HC19EESE0060
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Functional Oral Intake Scale

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

  during the intervention

• Cough strength

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

  during the intervention

Study Arms (2)

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

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

Dysphagia mild; Dysphagia severe

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

First ever stroke patients referred for swallowing disorders

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine

Bucheon-si, Kyounggido, South Korea

Location

MeSH Terms

Conditions

Respiration Disorders; Deglutition Disorders; Dysphonia; Stroke; Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Voice Disorders; Laryngeal Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases

Study Officials

• Sun Im, MD PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 28, 2021
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)