Deglutition Disorder
Conditions
Keywords
voice analysis aspiration prediction
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
Interventions
DEVICEVFSS
VFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol.
Sponsors
Ulsan University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed