NCT06936501

The Cooling Sensation Safe Deglution Study

Evaluation of the Perception of Freshness and Swallowing Safety in Stroke Patients With Dysphagia Receiving a Specially Designed Thickened Oral Nutritional Supplement: the Cooling Sensation Safe Deglution Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Dysphagia is a common complication in patients who have suffered a cerebrovascular accident (CVA), with an incidence ranging from 29% to 81%. Rehabilitation improves dysphagia in 47% of cases within the first few weeks and in 17% within 2-4 months. However, dysphagia can lead to nutritional and respiratory complications, affecting recovery and increasing healthcare costs due to the need for prolonged hospitalizations and readmissions. Malnutrition is a frequent consequence of CVA, with its prevalence increasing from 12% to 50% in patients with prolonged hospital stays. This condition worsens the vital prognosis, as it increases the incidence of complications and slows down functional recovery. Post-stroke dysphagia causes unsafe swallowing and increases the risk of aspiration, pneumonia, and other respiratory infections, worsening the patient's prognosis. Impaired swallowing efficiency leads to oral and pharyngeal residue, aggravating nutritional complications. On the other hand, swallowing safety is characterized by the presence of aspirations, manifesting as coughing, wet voice, and oxygen desaturation during the Volume-Viscosity Swallow Test (V-VST). The dietary management of these patients includes modifying food textures and using thickened liquids, strategies that have been shown to reduce the incidence of aspiration pneumonia. However, adherence to these diets is often low due to dissatisfaction with the texture and taste of thickening agents. In this context, the development of oral nutritional supplements (ONS) with stimulating flavors has been proposed to improve the perception of swallowing safety. Stimulation of the oropharyngeal sensory nerves, through activation by cold and chemical agents such as menthol, enhances swallowing by increasing oral sensitivity and improving the pharyngeal swallowing reflex response. The European Society for Swallowing Disorders (ESSD) recommends sensory stimulation as a therapeutic strategy to compensate for oropharyngeal sensory loss in patients with dysphagia. Previous studies have shown that sensory stimulation activates the swallowing center in the brainstem, accelerating the swallowing response and protecting the airway. In clinical trials with transient receptor potential (TRP) receptor agonists, observed benefits include faster closure of swallowing sphincters, improved swallowing reflex sensitivity, a 50% reduction in microaspirations, and a 67% decrease in pharyngeal residue. Based on this evidence, a new thickened ONS with stimulating flavors such as mango-mint and lemon-mint has been designed to enhance the perception of freshness and swallowing safety. This supplement is already used in clinical practice, but its effect on the perception of patients with post-stroke dysphagia has not yet been evaluated.

Conditions

• Neuromotor Dysphagia After Acute Stroke

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Traditional flavor ONS (vanilla or strawberry, by choice)	Receives a traditional flavor ONS (vanilla or strawberry, by choice) on days 1 and 2, then switches to a refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice) on days 3 and 4.
DIETARY_SUPPLEMENT	Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice)	Receives a refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice) on days 1 and 2, then switches to a traditional flavor ONS (vanilla or strawberry, by choice) on days 3 and 4.

Timeline

• Start date: 2025-05-19
• Primary completion: 2026-01-31
• Completion: 2026-03-30
• First posted: 2025-04-20
• Last updated: 2025-07-01

Locations

1 site across 1 country: Spain