MedDataX Logo

Bedside Screening Method for Patients With Potential Swallowing Impairment

NCT ID: NCT01158313

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deglutition Disorders Dysphagia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Thickener

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.

Thickened supplement

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Mataro

Mataró, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24628492 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HCN-DYS

Identifier Type: -

Identifier Source: org_study_id