The Cooling Sensation Safe Deglution Study

NCT ID: NCT06936501

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GROUP TR (Traditional-->Refreshing)

Group Type: ACTIVE_COMPARATOR

Traditional flavor ONS (vanilla or strawberry, by choice)

Intervention Type: 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 RT (Refreshing-->Traditional)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Olveira Fuster, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional de Malaga

Locations

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Gabriel Olveira Fuster, PhD, MD

Role: CONTACT

gabrielm.olveira.sspa@juntadeandalucia.es

+34 951290343 / +34 951030117

Facility Contacts

Gabriel Olveira Fuster, MD

Role: primary

gabrielm.olveira.sspa@juntadeandalucia.es

+34 951290343

Other Identifiers

DEGLUCOOLING

Identifier Type: -

Identifier Source: org_study_id