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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01158313
Other study ID # HCN-DYS
Secondary ID
Status Completed
Phase N/A
First received June 22, 2010
Last updated October 29, 2013
Start date July 2010
Est. completion date August 2011

Study information

Verified date October 2013
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date August 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Thickened 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

Locations

Country Name City State
Spain Hospital Mataro Mataró

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy 24 hour timeframe No
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