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

Deglutition Disorder Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01981239
• Other study ID #: chhwang4
• Status: Withdrawn
• Phase: N/A
• First received: November 4, 2013
• Last updated: December 1, 2014
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deglutition Disorder
• Deglutition Disorders

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No