Respiration DisordersNCT05098808
Artificial Intelligence in Diagnosing Dysphagia Patients
An observational study of Respiration Disorders and Swallowing Disorder, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Respiration Disorders, Swallowing Disorder, Phonation Disorder
- What is being tested?
- Acoustic features (from signals obtained during phonation)
- Type of treatment
- Pill or oral medicine
- How many people
- 449 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2019to 1 Oct 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Adult, Older adult
Study population: First ever stroke patients referred for swallowing disorders
Who may be able to join
- Inclusion criteria
- Suspected swallowing disorder who were referred for swallowing assessment
- Dysphagia attributable to brain lesion including stroke
Who cannot join
- Participants who were unable to perform phonation
- Participants who had no VFSS or standardized swallowing assessment results
- Participants with no spirometric measurements
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
Bucheon-si, Kyounggido
About this study
Official title: Classification of Dysphagia Patients at Risk of Aspiration Pneumonia Using Machine Learning Algorithms Incorporating Acoustic Features From Phonetic Evaluation
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.
- Conditions
- Respiration Disorders, Swallowing Disorder, Phonation Disorder, Stroke, Aspiration Pneumonia, Aspiration; Liquids
- Being tested
- Acoustic features (from signals obtained during phonation)
- Medical subject headings
- Respiration Disorders, Deglutition Disorders, Dysphonia, Stroke, Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Dysphagia mild | Able to start oral feeding after assessment Receives: Other: Acoustic features (from signals obtained during phonation) | |
| Dysphagia severe | Non oral feeding and high risk of aspiration Receives: Other: Acoustic features (from signals obtained during phonation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Oral Intake Scale
Dysphagia severity as measured by the the Functional Oral Intake Scale obtained from standardized swallowing tests
Measured: during the intervention
Cough strength
Spirometry values : cough strength as measured by the spirometric values during voluntary cough
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Sep 2019
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 449 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
- Investigators
- Sun Im, MD PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098808
- Sponsor's protocol ID
- HC19EESE0060
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data would be accessible only upon formal request to the formal PI
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Dysphagia Patients at Risk of Aspiration Pneumonia Using Machine Learning Algorithms Incorporating Acoustic Features From Phonetic Evaluation
- ClinicalTrials.gov ID
- NCT05098808
- Acronym / sponsor ID
- HC19EESE0060
- Conditions
- Respiration Disorders, Swallowing Disorder, Phonation Disorder, Stroke, Aspiration Pneumonia, Aspiration; Liquids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysphagia mild | – | Other: Acoustic features (from signals obtained during phonation)Able to start oral feeding after assessment |
| Dysphagia severe | – | Other: Acoustic features (from signals obtained during phonation)Non oral feeding and high risk of aspiration |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- First ever stroke patients referred for swallowing disorders
Key inclusion criteria (3 listed)
- Inclusion criteria
- Suspected swallowing disorder who were referred for swallowing assessment
- Dysphagia attributable to brain lesion including stroke
Key exclusion criteria (3 listed)
- Participants who were unable to perform phonation
- Participants who had no VFSS or standardized swallowing assessment results
- Participants with no spirometric measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic 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 | Other | Dysphagia mild, Dysphagia severe |
Primary outcome
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
Cough strength
Time frame: during the intervention
Spirometry values : cough strength as measured by the spirometric values during voluntary cough
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No. Data would be accessible only upon formal request to the formal PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Im, MD PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration Disorders and Swallowing Disorder, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Oral Intake Scale (time frame: during the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.