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Previous studies have shown that most patients with functional oropharyngeal dysphagia could be quickly, safely and accurately recognized by using a clinical bedside method developed by the investigative team as the volume-viscosity swallow test (V-VST) that systematically evaluates the main clinical signs and symptoms of safety and efficacy of swallowing and monitors pulse oximetry to improve the detection of patients with silent aspirations.The aim of this study is to validate this test for persons suspected of having swallowing impairment, using a new thickener, with respect to the Videofluoroscopy (VFS) method (treated as the gold standard).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thickener | Patients with history of swallowing difficulties associated with aging and/or neurological diseases including patients with:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thickened supplement | Dietary Supplement | New thickener to be mixed to liquid to obtain different viscosities such as nectar viscosity, honey viscosity, conservative spoon-thick viscosity (CST) and extreme spoon-thick viscosity (EST |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia. | Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia. | 24 hour period |
| Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of safety in swallowing. | Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of safety in swallowing. | 24 hour period |
| Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of efficacy in swallowing. | Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of efficacy in swallowing. | 24 hour period |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy | 24 hour timeframe |
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Inclusion Criteria:
Exclusion Criteria:
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120 Patients suspected of having symptoms of swallowing impairment will be enrolled in the study as well as 14 healthy volunteers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Mataro | MatarĂ³ | 08304 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24628492 | Derived | Rofes L, Arreola V, Mukherjee R, Swanson J, Clave P. The effects of a xanthan gum-based thickener on the swallowing function of patients with dysphagia. Aliment Pharmacol Ther. 2014 May;39(10):1169-79. doi: 10.1111/apt.12696. Epub 2014 Mar 13. |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| D010038 | Otorhinolaryngologic Diseases |