Effect of a Cooling Sensation Flavor on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia

Launched by HOSPITAL DE MATARÓ · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a special cooling flavor in a drink can help improve swallowing in patients who have difficulty swallowing after a stroke, a condition known as oropharyngeal dysphagia. Researchers want to see if this cooling sensation, combined with a thicker drink, can make swallowing easier and safer for these patients. The trial will involve two groups of 25 participants each, who will try both the cooling flavor and a control drink during two separate visits.

To be eligible for the trial, participants must be at least 18 years old and have had a stroke at least three months prior, resulting in chronic swallowing difficulties. They should be able to safely swallow both the study drink and the control drink. Throughout the trial, participants will undergo various assessments related to their swallowing ability. This study is currently recruiting participants and aims to find a new way to help improve the quality of life for those with swallowing disorders following a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥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
• Exclusion Criteria:
• • Pregnancy
• • 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