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The Cooling Sensation Safe Deglution Study

RecruitingNAAges 18 Years - 99 YearsAllFundación Pública Andaluza para la Investigación …
NCT06936501 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Traditional flavor ONS (vanilla or strawberry, by choice)
  • Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice)
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Where

1 site
Hospital Regional Universitario de Málaga
Málaga, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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