Effect of a Cooling Sensation Flavor on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia
NCT ID: NCT06250426
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-10-21
2025-01-31
Brief Summary
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In recent years, new neurorehabilitation treatment strategies for OD have been developed such as peripheral (electrical or chemical stimulation) or central stimulation (transcranial direct current stimulation or repetitive transcranial magnetic stimulation).
The investigators suggest that new generation treatments for OD have to combine thickened fluids and about peripheral stimulation using transient receptor potential (TRP) channels agonists. The aim of this study is to evaluate the therapeutic effect of a cooling sensation (CS) flavor in a pre-thickened oral nutritional supplement (ONS) drink on the biomechanical mechanism of the swallow response in chronic post-stroke patients with OD.
The investigators designed a randomized, crossover, interventional and open-label clinical study. The study includes 2 groups: 1) n=25: 1st visit: stimulation with Control, 2nd visit: stimulation with CS; and 2) n=25: 1st visit: stimulation with CS, 2nd visit: stimulation with Control. Each patient will attend a total of 2 visits, with a washing period of at least 7 days between visits. The procedures to be performed during each visit are: clinical assessment of swallowing with V-VST, spontaneous swallowing frequency measurement using electromyography, and collection of a sample of saliva using a Salivette®.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Active
Pre-thickened oral nutritional supplement with a cooling sensation flavour
Pre-thickened oral nutritional supplement with a cooling sensation flavour
Pre-thickened oral nutritional supplement (ONS) drink with cooling sensation flavour
Control
Pre-thickened oral nutritional supplement without a cooling sensation flavour
Pre-thickened oral nutritional supplement without a cooling sensation flavour
Pre-thickened oral nutritional supplement (ONS) drink without cooling sensation flavour
Interventions
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Pre-thickened oral nutritional supplement with a cooling sensation flavour
Pre-thickened oral nutritional supplement (ONS) drink with cooling sensation flavour
Pre-thickened oral nutritional supplement without a cooling sensation flavour
Pre-thickened oral nutritional supplement (ONS) drink without cooling sensation flavour
Eligibility Criteria
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Inclusion Criteria
* Patients with chronic OD as a consequence of stroke (more than 3 month since stroke diagnostic)
* Patients with impaired safety and/or efficacy of swallow (V-VST)
* Patients that can swallow safely the investigation and control product according to the viscosity of the product and the results of the V-VST
* Patients able to follow the protocol and give informed consent
Exclusion Criteria
* Life expectancy \<3 months or palliative care
* OD diagnosis prior to stroke
* Dementia (GDS 4 or higher)
* Allergy to the investigation and/or control product or to any of its components
* Participation in another interventional study in the month prior to inclusion
* Current users of a pre-thickened ONS drink with cooling sensation flavor
18 Years
ALL
No
Sponsors
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Nutricia Research
INDUSTRY
Hospital de Mataró
OTHER
Responsible Party
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Pere Clave
Principal Investigator
Locations
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Hospital de Mataró
Mataró, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Refresh
Identifier Type: -
Identifier Source: org_study_id
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