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

Study Overview
=================
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

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

Conditions
-----------------
Deglutition Disorder

Intervention / Treatment
-----------------
* Device: VFSS


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voice analysis aspiration prediction