The Cooling Sensation Safe Deglution Study

NCT06936501 | Recruiting

• 1 other identifier: DEGLUCOOLING
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dysphagia; cerebrovascular accident; oral nutritional supplements

Outcome Measures

Primary Outcomes (3)

• Perception of swallowing safety of thickened ONS

  Objective: To assess the perceived safety when swallowing based on the flavor of the thickened ONS. * Ad hoc questionnaire , designed exclusively for this study * Two closed-ended questions * Response scale: Visual Numeric Scale (VNS) from 0 to 10 * 0 = No sensation of safety * 10 = Maximum sensation of safety * Based on previously used scales in healthy individuals

  At 48 and 96 hours

• Assessment using selected items from the validated Spanish version of the EAT-10 scale

  * Items focused on perceived safety during swallowing: * Item 8: "When I swallow, food sticks in my throat." * Item 9: "I cough when I eat." * Item 10: "Swallowing is stressful." Responses are scored from 0 to 4, where 0 = no problem; 4 = severe problem This scale is validated in Spanish. The combination of a validated scale and an ad hoc scale seeks to strengthen the study's methodological robustness.

  At 48 and 96 hours

• Perception of freshness of thickened ONS

  Objective: To assess the perception of freshness that stimulates swallowing, depending on the flavor of the thickened ONS received. * Ad hoc questionnaire , designed exclusively for this study * Three closed-ended questions * Response scale: Visual Numeric Scale (VNS) from 0 to 10 * 0 = No freshness * 10 = Maximum sensation of freshness * Based on scales used previously in healthy subjects

  At 48 and 96 hours

Secondary Outcomes (3)

• Evaluation of Satisfaction of thickened ONS

  At 48 and 96 hours

• Evaluation of Tolerability of thickened ONS

  At 48 and 96 hours

• Evaluation of Consumption of thickened ONS

  At 48 and 96 hours

Study Arms (2)

GROUP TR (Traditional-->Refreshing)

ACTIVE COMPARATOR

Dietary Supplement: Traditional flavor ONS (vanilla or strawberry, by choice)

GROUP RT (Refreshing-->Traditional)

ACTIVE COMPARATOR

Dietary Supplement: Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice)

Interventions

Traditional flavor ONS (vanilla or strawberry, by choice) DIETARY_SUPPLEMENT

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.

GROUP TR (Traditional-->Refreshing)

Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice) DIETARY_SUPPLEMENT

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.

GROUP RT (Refreshing-->Traditional)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years old.
• Currently hospitalized due to an acute stroke.
• Confirmed diagnosis of dysphagia through V-VST (Volume-Viscosity Swallow Test).
• Ability to collaborate and respond to questionnaire questions and other research tools used in the study.
• Malnutrition or risk of malnutrition, requiring a thickened, high-calorie, high-protein ONS, as determined by medical assessment in routine clinical practice.
• Voluntary written informed consent to participate in the study.

You may not qualify if:

• Moderate to severe cognitive impairment that interferes with the correct interpretation of the study or its requirements.
• Diagnosis of advanced dementia, severe psychiatric illness, or any other central nervous system condition that impairs the patient's comprehension of the study.
• Sociocultural, linguistic, intellectual, or other factors that hinder the patient's proper understanding of the study.
• Diagnosis of galactosemia.
• Intolerance or refusal (for any reason) of oral nutritional supplements.
• Requirement for parenteral nutrition or contraindication to oral intake.
• Severe active renal, hepatic, or gastrointestinal diseases that contraindicate the use of ONS

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Hospital Regional Universitario de Málaga

Málaga, Málaga, 29009, Spain

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gabriel Olveira Fuster, PhD, MD

  Hospital Regional de Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Olveira Fuster, PhD, MD

CONTACT

+34 951290343 / +34 951030117; gabrielm.olveira.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1 ratio

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 20, 2025
• Study Start: May 19, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-04

Locations

ES (1)