Deglutition DisorderNCT01981239
Voice Analysis Using the LPC (Linear Predictive Coding)Method for the Prediction of Aspiration
A study testing VFSS in people with Deglutition Disorder, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
It was well known that aspiration is the primary cause of an aspiration pneumonia among the dysphagia patients. In order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are invasive and allowed only in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deglutition Disorder
- What is being tested?
- VFSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Dec 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who were referred for VFSS
Who cannot join
- Patients cannot phonate d/t tracheostomy
- Preexisting oro-laryngo-pharyngeal disease
- Patients cannot follow 1 step command
- Patients cannot maintain a phonation for 3 seconds
- Refusal of participation
- Patients who were not classified for the candidate by physicians
- Patients who coughs following drinking of 5ml normal saline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voice Analysis Using the LPC (Linear Predictive Coding)Method for the Prediction of Aspiration;Prospective, Positive-controlled, Single-blind, Single Cohort Clinical Study of Efficacy
It was well known that aspiration is the primary cause of an aspiration pneumonia among the dysphagia patients.
In order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are invasive and allowed only in a limited condition.
Read more
In this study, as a precedent study for the non-linear analysis, voice analysis using LPC method will be evaluated. The superiority of LPC method will be compared with a spectral analysis using Jitter and Simmer as a positive control.
This clinical study will be performed prospective, positive-controlled, single-blind (i.e. assessor-blind),and single cohort clinical trial for efficacy
- Conditions
- Deglutition Disorder
- Being tested
- VFSS
- Keywords
- voice analysis aspiration prediction
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VFSSDevice
VFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol.
| Study group | Role | What they receive |
|---|---|---|
| LPC analysis group | Experimental | Voice sampling is executed before and immediately after drinking of 20ml N/S and linear voice analyses using LPC method are performed to calculate LPC index, residual variance, coefficiency mean, coeffiency variance, and coeffiency skewness. Receives: Device: VFSS |
| spectral analysis group | Active comparator | Voice sampling is executed before and immediately after drinking of 20ml N/S and spectral voice analyses using Dr. Speech program are performed to calculate HNR (dB), RAP (%: Jitter), Mean and SD Fundamental Frequency (Hz: Fo), Shimmer (%) and SNR (dB). Receives: Device: VFSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPC index
Voice sampling before and immediately after drinking of 20ml N/S and linear analysis using LPC method
Measured: one day before or after VFFS
Secondary outcomes (3)
Spectral Analysis
Voice sampling is performed before and immediately after drinking of 20ml N/S and HNR (dB), RAP (%: Jitter), Mean and SD Fundamental Frequency (Hz: Fo), Shimmer (%) and SNR (dB) are calculated using Dr. Speech program.
Measured: one day before or after VFFS
LPC anaysis
Voice sampling is performed before and immediately after drinking of 20ml N/S and residual variance, coefficiency mean, coeffiency variance, and coeffiency skewness are computed using LPC analysis program.
Measured: one day after or before VFSS
Risk group
According to Penetration-aspiration scale, patients are classified into high-risk patients (grade IV-VIII) and low-risk patients (grade I-III) by using the data derived from videofluoroscopic swallowing study
Measured: whithin one hour of VFSS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: no participation over the long period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ho Hwang, Ulsan University Hospital
- Investigators
- Chang Ho Hwang, M.D. & Ph.D., Study director, Ulsan University HospitalHyungseob Han, M.Sc., Principal investigator, University of Ulsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981239
- Sponsor's protocol ID
- chhwang4
- Status last verified
- Dec 2014
- First submitted
- 4 Nov 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Analysis Using the LPC (Linear Predictive Coding)Method for the Prediction of Aspiration;Prospective, Positive-controlled, Single-blind, Single Cohort Clinical Study of Efficacy
- ClinicalTrials.gov ID
- NCT01981239
- Acronym / sponsor ID
- chhwang4
- Conditions
- Deglutition Disorder
- Keywords
- voice analysis aspiration prediction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participation over the long period
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Nov 2013 (estimated)
- 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.
It was well known that aspiration is the primary cause of an aspiration pneumonia among the dysphagia patients.
In order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are invasive and allowed only in a limited condition.
In this study, as a precedent study for the non-linear analysis, voice analysis using LPC method will be evaluated. The superiority of LPC method will be compared with a spectral analysis using Jitter and Simmer as a positive control.
This clinical study will be performed prospective, positive-controlled, single-blind (i.e. assessor-blind),and single cohort clinical trial for efficacy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPC analysis group | Experimental | Device: VFSSVoice sampling is executed before and immediately after drinking of 20ml N/S and linear voice analyses using LPC method are performed to calculate LPC index, residual variance, coefficiency mean, coeffiency variance, and coeffiency skewness. |
| spectral analysis group | Active comparator | Device: VFSSVoice sampling is executed before and immediately after drinking of 20ml N/S and spectral voice analyses using Dr. Speech program are performed to calculate HNR (dB), RAP (%: Jitter), Mean and SD Fundamental Frequency (Hz: Fo), Shimmer (%) and SNR (dB). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were referred for VFSS
Key exclusion criteria (7 listed)
- Patients cannot phonate d/t tracheostomy
- Preexisting oro-laryngo-pharyngeal disease
- Patients cannot follow 1 step command
- Patients cannot maintain a phonation for 3 seconds
- Refusal of participation
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 |
|---|---|---|
| VFSSVFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol. | Device | LPC analysis group, spectral analysis group |
Primary outcome
LPC index
Time frame: one day before or after VFFS
Voice sampling before and immediately after drinking of 20ml N/S and linear analysis using LPC method
3 secondary outcomes
Spectral Analysis
Time frame: one day before or after VFFS
LPC anaysis
Time frame: one day after or before VFSS
Risk group
Time frame: whithin one hour of VFSS
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
Related trials for Deglutition Disorder
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life
Periodontitis, Periodontal Diseases
Not yet recruiting
Standardizing Swallow Pressure Measurements
Dysphagia
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
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.
Chang Ho Hwang, M.D. & Ph.D. study director
Ulsan University Hospital
Hyungseob Han, M.Sc. principal investigator
University of Ulsan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VFSS in people with Deglutition Disorder, run by Ulsan University Hospital 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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 3 Dec 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
LPC index (time frame: one day before or after VFFS). 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 3 Dec 2014.