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

NCT ID: NCT01981239

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Deglutition Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

VFSS

Intervention Type DEVICE

VFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol.

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).

Group Type ACTIVE_COMPARATOR

VFSS

Intervention Type DEVICE

VFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Ho Hwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Ho Hwang, M.D. & Ph.D.

Role: STUDY_DIRECTOR

Ulsan University Hospital

Hyungseob Han, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

University of Ulsan

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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chhwang4

Identifier Type: -

Identifier Source: org_study_id