- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05098808
Artificial Intelligence in Diagnosing Dysphagia Patients
Classification of Dysphagia Patients at Risk of Aspiration Pneumonia Using Machine Learning Algorithms Incorporating Acoustic Features From Phonetic Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kyounggido
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Bucheon, Kyounggido, Korea, Republic of
- Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dysphagia mild
Able to start oral feeding after assessment
|
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 severe
Non oral feeding and high risk of aspiration
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during the intervention
|
Cough strength
Time Frame: during the intervention
|
Spirometry values : cough strength as measured by the spirometric values during voluntary cough
|
during the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sun Im, MD PhD, The Catholic University of Korea
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Neurologic Manifestations
- Gastrointestinal Diseases
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Esophageal Diseases
- Laryngeal Diseases
- Disease
- Pneumonia
- Deglutition Disorders
- Pneumonia, Aspiration
- Respiration Disorders
- Dysphonia
- Voice Disorders
Other Study ID Numbers
- HC19EESE0060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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