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NCT Number: NCT06936501

The Cooling Sensation Safe Deglution Study

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.

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Key information

Conditions

Neuromotor Dysphagia After Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

Location status: Recruiting

Location contact

Gabriel Olveira Fuster, MD

CONTACT

[email protected]

+34 951290343

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Perception of swallowing safety of thickened ONS

    Time frame: At 48 and 96 hours

    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

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

    Time frame: At 48 and 96 hours

    • 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.

  3. Perception of freshness of thickened ONS

    Time frame: At 48 and 96 hours

    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

Secondary outcomes

  1. Evaluation of Satisfaction of thickened ONS

    Time frame: At 48 and 96 hours

    Objective: To assess patient satisfaction with the thickened ONS.

    • Ad hoc questionnaire , designed exclusively for this study
    • Based on statements related to:
    • Safety
    • Texture
    • Mouthfeel
    • Overall satisfaction
    • 5-point Likert scale:
    • 1 = Not at all
    • 5 = Very much

  2. Evaluation of Tolerability of thickened ONS

    Time frame: At 48 and 96 hours

    Objective: To assess perceived tolerability of the thickened ONS.

    • Ad hoc questionnaire, designed exclusively for this study
    • Includes 7 closed-ended questions
    • Visual Numeric Scale (VNS) from 0 to 10:
    • 0 = Not tolerable at all
    • 10 = Fully tolerable

  3. Evaluation of Consumption of thickened ONS

    Time frame: At 48 and 96 hours

    Objective: To record the amount of thickened ONS consumed compared to the medical recommendation.

    • Ad hoc questionnaire (not validated), designed exclusively for this study
    • Patient's intake percentage:
    • 100%, 75%, 50%, 25%, 0%
    • If <50% was consumed, patients will indicate one or more of the following reasons:
    • TASTE is unpleasant
    • SMELL is unpleasant
    • TEXTURE is unpleasant
    • APPEARANCE is unpleasant
    • VOLUME is too much
    • Poor TOLERANCE
    • FEAR of swallowing
    • PAIN when swallowing
    • FORGOT to take it

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Olveira Fuster, PhD, MD

CONTACT

[email protected]

+34 951290343 / +34 951030117

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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