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

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.

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 Overview

• Status: Withdrawn
• Conditions: Deglutition Disorder
• Intervention / Treatment: Device: VFSS

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 682-714
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LPC analysis group; 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.	Device: VFSS; VFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol.
Active Comparator: spectral analysis group; 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).	Device: VFSS; VFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LPC index	Voice sampling before and immediately after drinking of 20ml N/S and linear analysis using LPC method	one day before or after VFFS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	whithin one hour of VFSS

Collaborators and Investigators

• Sponsor: Ulsan University Hospital
• Investigators: Study Director: Chang Ho Hwang, M.D. & Ph.D., Ulsan University Hospital; Principal Investigator: Hyungseob Han, M.Sc., University of Ulsan

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: voice analysis aspiration prediction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: chhwang4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No