Neuromotor Dysphagia After Acute StrokeNCT06936501
The Cooling Sensation Safe Deglution Study
A study testing Traditional flavor ONS (vanilla or strawberry, by choice) and Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice) in people with Neuromotor Dysphagia After Acute Stroke, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neuromotor Dysphagia After Acute Stroke
- What is being tested?
- Traditional flavor ONS (vanilla or strawberry, by choice) and Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 19 May 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gabriel Olveira Fuster, PhD, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, Málaga, 29009
Gabriel Olveira Fuster, MD, +34 951290343, gabrielm.olveira.sspa@juntadeandalucia.es
About this study
Official 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
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.
Read more
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
- Being tested
- Traditional flavor ONS (vanilla or strawberry, by choice), Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice)
- Keywords
- dysphagia, cerebrovascular accident, oral nutritional supplements
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP TR (Traditional-->Refreshing) | Active comparator | Not described Receives: Dietary Supplement: Traditional flavor ONS (vanilla or strawberry, by choice) |
| GROUP RT (Refreshing-->Traditional) | Active comparator | Not described Receives: Dietary Supplement: Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: At 48 and 96 hours
Secondary outcomes (3)
Evaluation of Satisfaction of thickened ONS
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
Measured: At 48 and 96 hours
Evaluation of Tolerability of thickened ONS
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
Measured: At 48 and 96 hours
Evaluation of Consumption of thickened ONS
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
Measured: At 48 and 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start19 May 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromotor Dysphagia After Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Olveira Fuster, PhD, MD, Principal investigator, Hospital Regional de Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936501
- Sponsor's protocol ID
- DEGLUCOOLING
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06936501
- Acronym / sponsor ID
- DEGLUCOOLING
- Conditions
- Neuromotor Dysphagia After Acute Stroke
- Keywords
- dysphagia, cerebrovascular accident, oral nutritional supplements
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | GROUP TR (Traditional-->Refreshing) |
| 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. | Dietary supplement | GROUP RT (Refreshing-->Traditional) |
Primary outcome
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
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.
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
3 secondary outcomes
Evaluation of Satisfaction of thickened ONS
Time frame: At 48 and 96 hours
Evaluation of Tolerability of thickened ONS
Time frame: At 48 and 96 hours
Evaluation of Consumption of thickened ONS
Time frame: At 48 and 96 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel Olveira Fuster, PhD, MD contact
Gabriel Olveira Fuster, PhD, MD principal investigator
Hospital Regional de Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional flavor ONS (vanilla or strawberry, by choice) and Refreshing and stimulating flavor ONS (mango-peppermint or lemon-mint, by choice) in people with Neuromotor Dysphagia After Acute Stroke, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Olveira Fuster, PhD, MD (+34 951290343 / +34 951030117, gabrielm.olveira.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of swallowing safety of thickened ONS (time frame: At 48 and 96 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.