Bedside Screening Method for Patients With Potential Swallowing Impairment

Study Overview
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Brief Summary
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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).

Official Title
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Development and Validation of Clinician-administered Bedside Screening Method for Patients With Potential Swallowing Impairment

Conditions
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Deglutition Disorders, Dysphagia

Intervention / Treatment
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* Dietary Supplement: Thickened supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of swallowing difficulties associated with aging and/or neurological diseases including patients with: -neurodegenerative diseases. -non-progressive neurological diseases including stroke. -older patients including nursing home patients. Age > 18 y Ability to give informed consent Exclusion Criteria: Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study Patients with a background of alcohol dependence or other drug dependence Patient who cannot be expected to comply with treatment Patient currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thickener<br>Patients with history of swallowing difficulties associated with aging and/or neurological diseases including patients with: neurodegenerative diseases. non-progressive neurological diseases including stroke. older patients including nursing home patients. | Dietary Supplement: Thickened supplement<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |