Deglutition DisordersCABSNCT01158313
Bedside Screening Method for Patients With Potential Swallowing Impairment
An observational study of Deglutition Disorders and Dysphagia, run by Société des Produits Nestlé (SPN) at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorders, Dysphagia
- What is being tested?
- Thickened supplement
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 120 Patients suspected of having symptoms of swallowing impairment will be enrolled in the study as well as 14 healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of Clinician-administered Bedside Screening Method for Patients With Potential Swallowing Impairment
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).
- Conditions
- Deglutition Disorders, Dysphagia
- Being tested
- Thickened supplement
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thickened supplementDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Thickened supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 hour period
Secondary outcomes (1)
Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy
Measured: 24 hour timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158313
- Sponsor's protocol ID
- HCN-DYS
- Acronym
- CABS
- Status last verified
- Oct 2013
- First submitted
- 22 Jun 2010
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24628492
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Clinician-administered Bedside Screening Method for Patients With Potential Swallowing Impairment
- ClinicalTrials.gov ID
- NCT01158313
- Acronym / sponsor ID
- CABS / HCN-DYS
- Conditions
- Deglutition Disorders, Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thickener | – | Dietary Supplement: Thickened supplementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 120 Patients suspected of having symptoms of swallowing impairment will be enrolled in the study as well as 14 healthy volunteers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thickened supplementNew 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 | Dietary supplement | Thickener |
Primary outcome
Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia.
Time frame: 24 hour period
Diagnostic accuracy in terms of sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia.
Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of safety in swallowing.
Time frame: 24 hour period
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.
Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of impairment of efficacy in swallowing.
Time frame: 24 hour period
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.
1 secondary outcome
Sensitivities and specificities of the V-VST relative to VFS for individual signs of impaired safety and efficacy
Time frame: 24 hour timeframe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Derived from this study: PubMed 24628492Rofes 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders and Dysphagia, run by Société des Produits Nestlé (SPN) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the V-VST relative to VFS using THICKENER, in the diagnosis of oropharyngeal dysphagia. (time frame: 24 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.