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

NCT01981239 | Withdrawn DMC

• 1 other identifier: chhwang4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Deglutition Disorder

Keywords

voice analysis aspiration prediction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Spectral Analysis

  one day before or after VFFS

• LPC anaysis

  one day after or before VFSS

• Risk group

  whithin one hour of VFSS

Study Arms (2)

LPC analysis group

EXPERIMENTAL

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

spectral analysis group

ACTIVE COMPARATOR

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

Interventions

VFSS 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.

LPC analysis group; spectral analysis group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were referred for VFSS

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulsan University Hospital: lead

Study Sites (1)

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Chang Ho Hwang, M.D. & Ph.D.

  Ulsan University Hospital

  STUDY DIRECTOR

• Hyungseob Han, M.Sc.

  University of Ulsan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

KR (1)