Status:
RECRUITING
The Cooling Sensation Safe Deglution Study
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Conditions:
Neuromotor Dysphagia After Acute Stroke
Eligibility:
All Genders
18-99 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06936501
Start Date
May 19 2025
End Date
March 30 2026
Last Update
July 1 2025
Active Locations (1)
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1
Hospital Regional Universitario de Málaga
Málaga, Málaga, Spain, 29009