Not provided
Not provided
Not provided
Not provided
Not provided
no participation over the long period
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chang Ho Hwang, M.D. & Ph.D. | Ulsan University Hospital | Study Director |
| Hyungseob Han, M.Sc. | University of Ulsan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan University Hospital | Ulsan | 682-714 | South Korea |
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D010038 | Otorhinolaryngologic Diseases |