REFRESH Study: Therapeutic Effect of a Cooling Sensation Flavor in Pre-thickened ONS Products on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Current oropharyngeal dysphagia (OD) treatment in older patients is based on compensatory strategies (fluid thickening and texture modified diets) that improve swallow safety but do not improve the swallowing function. One of these strategies is thickening products, which are used to reduce pharyngeal bolus velocity by increasing viscosity of fluids. There are several studies demonstrating the therapeutic effect of thickeners in reducing the prevalence of penetrations and aspirations, and their use has been correlated with reduced prevalence of respiratory infections, aspiration pneumonia and hospital readmissions. 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®.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years

• 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

Locations
Other Locations
Spain
Hospital de Mataró
RECRUITING
Mataró
Contact Information
Primary
Pere Clavé, MD, PhD
pere.clave@ciberehd.org
937417700
Time Frame
Start Date: 2023-10-21
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 50
Treatments
Active_comparator: Active
Pre-thickened oral nutritional supplement with a cooling sensation flavour
Placebo_comparator: Control
Pre-thickened oral nutritional supplement without a cooling sensation flavour
Related Therapeutic Areas
Sponsors
Collaborators: Nutricia Research
Leads: Hospital de Mataró

This content was sourced from clinicaltrials.gov