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Voice Analysis Using the LPC (Linear Predictive Coding)Method for the Prediction of Aspiration

Primary Purpose

Deglutition Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
VFSS
Sponsored by
Ulsan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deglutition Disorder focused on measuring voice analysis aspiration prediction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who were referred for VFSS

Exclusion Criteria:

  • 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

Sites / Locations

  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LPC analysis group

spectral analysis group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

LPC index
Voice sampling before and immediately after drinking of 20ml N/S and linear analysis using LPC method

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
November 4, 2013
Last Updated
December 1, 2014
Sponsor
Ulsan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01981239
Brief Title
Voice Analysis Using the LPC (Linear Predictive Coding)Method for the Prediction of Aspiration
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
no participation over the long period
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ulsan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorder
Keywords
voice analysis aspiration prediction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LPC analysis group
Arm Type
Experimental
Arm Description
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.
Arm Title
spectral analysis group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
VFSS
Intervention Description
VFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol.
Primary Outcome Measure Information:
Title
LPC index
Description
Voice sampling before and immediately after drinking of 20ml N/S and linear analysis using LPC method
Time Frame
one day before or after VFFS
Secondary Outcome Measure Information:
Title
Spectral Analysis
Description
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.
Time Frame
one day before or after VFFS
Title
LPC anaysis
Description
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.
Time Frame
one day after or before VFSS
Title
Risk group
Description
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
Time Frame
whithin one hour of VFSS

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who were referred for VFSS Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Ho Hwang, M.D. & Ph.D.
Organizational Affiliation
Ulsan University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hyungseob Han, M.Sc.
Organizational Affiliation
University of Ulsan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of

12. IPD Sharing Statement

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Voice Analysis Using the LPC (Linear Predictive Coding)Method for the Prediction of Aspiration

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