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

Not Applicable

Withdrawn

• Conditions: Deglutition Disorder
• Interventions: Device: VFSS

• Registration Number: NCT01981239
• Lead Sponsor: Ulsan University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LPC analysis group	VFSS	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.
spectral analysis group	VFSS	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Spectral Analysis	one day before or after VFFS	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	one day after or before VFSS	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	whithin one hour of VFSS	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

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of