Oropharyngeal DysphagiaNCT06250426

Effect of a Cooling Sensation Flavor on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia

A study testing Pre-thickened oral nutritional supplement with a cooling sensation flavour and Pre-thickened oral nutritional supplement without a cooling sensation flavour in people with Oropharyngeal Dysphagia and Stroke, run by Hospital de Mataró at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Oropharyngeal Dysphagia, Stroke, Swallowing Disorder
What is being tested?: Pre-thickened oral nutritional supplement with a cooling sensation flavour and Pre-thickened oral nutritional supplement without a cooling sensation flavour
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteSpain
Study dates: 21 Oct 2023to 31 Jan 2025
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 years
Patients with chronic OD as a consequence of stroke (more than 3 month since stroke diagnostic)
Patients with impaired safety and/or efficacy of swallow (V-VST)
Patients that can swallow safely the investigation and control product according to the viscosity of the product and the results of the V-VST
Patients able to follow the protocol and give informed consent

Who cannot join

Pregnancy
Life expectancy <3 months or palliative care
OD diagnosis prior to stroke
Dementia (GDS 4 or higher)
Allergy to the investigation and/or control product or to any of its components
Participation in another interventional study in the month prior to inclusion
Current users of a pre-thickened ONS drink with cooling sensation flavor

Trial locations and contacts

1 site in 1 country.

Pere Clavé, MD, PhD contact

937417700 ext. 2284

pere.clave@ciberehd.org

Spain1 site, 1 recruiting

Hospital de Mataró
Mataró, Barcelona, 08304
Pere Clavé, MD, 937417700 ext. 2284, pere.clave@ciberehd.org
Pere Clavé, MD, PhD
Recruiting

Other trials in Spain

About this study

Official title: REFRESH Study: Therapeutic Effect of a Cooling Sensation Flavor in Pre-thickened ONS Products on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia

Current oropharyngeal dysphagia (OD) treatment in older patients is based on compensatory strategies (fluid thickening and texture modified diets) that improve swallow safety but do not improve the swallowing function. One of these strategies is thickening products, which are used to reduce pharyngeal bolus velocity by increasing viscosity of fluids. There are several studies demonstrating the therapeutic effect of thickeners in reducing the prevalence of penetrations and aspirations, and their use has been correlated with reduced prevalence of respiratory infections, aspiration pneumonia and hospital readmissions.

In recent years, new neurorehabilitation treatment strategies for OD have been developed such as peripheral (electrical or chemical stimulation) or central stimulation (transcranial direct current stimulation or repetitive transcranial magnetic stimulation).

The investigators suggest that new generation treatments for OD have to combine thickened fluids and about peripheral stimulation using transient receptor potential (TRP) channels agonists. The aim of this study is to evaluate the therapeutic effect of a cooling sensation (CS) flavor in a pre-thickened oral nutritional supplement (ONS) drink on the biomechanical mechanism of the swallow response in chronic post-stroke patients with OD.

The investigators designed a randomized, crossover, interventional and open-label clinical study. The study includes 2 groups: 1) n=25: 1st visit: stimulation with Control, 2nd visit: stimulation with CS; and 2) n=25: 1st visit: stimulation with CS, 2nd visit: stimulation with Control. Each patient will attend a total of 2 visits, with a washing period of at least 7 days between visits. The procedures to be performed during each visit are: clinical assessment of swallowing with V-VST, spontaneous swallowing frequency measurement using electromyography, and collection of a sample of saliva using a Salivette®.

Conditions: Oropharyngeal Dysphagia, Stroke, Swallowing Disorder
Being tested: Pre-thickened oral nutritional supplement with a cooling sensation flavour, Pre-thickened oral nutritional supplement without a cooling sensation flavour
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.

Pre-thickened oral nutritional supplement with a cooling sensation flavourDietary supplement
Pre-thickened oral nutritional supplement (ONS) drink with cooling sensation flavour
Pre-thickened oral nutritional supplement without a cooling sensation flavourDietary supplement
Pre-thickened oral nutritional supplement (ONS) drink without cooling sensation flavour

Study groups in NCT06250426
Study group	Role	What they receive
Active	Active comparator	Pre-thickened oral nutritional supplement with a cooling sensation flavour Receives: Dietary Supplement: Pre-thickened oral nutritional supplement with a cooling sensation flavour
Control	Placebo comparator	Pre-thickened oral nutritional supplement without a cooling sensation flavour Receives: Dietary Supplement: Pre-thickened oral nutritional supplement without a cooling sensation flavour

What is being measured

The primary outcome is the main question the study is designed to answer.

Pre visit 1 Spontaneous swallowing frequency (SSF)
SSF will be measured with surface neck electromyography (sEMG) and accelerometry for 10min, in which the patient will be asked to breathe normally and to remain calm and quiet. sEMG electrodes will be placed over the digastric-mylohyoid complex and an omnidirectional accelerometer over the cricothyroid cartilage to assess the number of swallows per minute.
Measured: Pre intervention in visit 1 (baseline)
Pre visit 1 EMG metrics
EMG metrics (amplitude (Volts), latency (seconds), duration (seconds) and area under the curve (volts·second)) of the recordings using the AcqKnowledge 4.4 software (BIOPAC Systems, USA) will be analyzed and combined to describe the electromyographic response of the suprahyoid muscles.
Measured: Pre intervention in visit 1 (baseline)
Post visit 1 Spontaneous swallowing frequency (SSF)
SSF will be measured with surface neck electromyography (sEMG) and accelerometry for 10min, in which the patient will be asked to breathe normally and to remain calm and quiet. sEMG electrodes will be placed over the digastric-mylohyoid complex and an omnidirectional accelerometer over the cricothyroid cartilage to assess the number of swallows per minute.
Measured: Post intervention in visit 1 (baseline)
Post visit 1 EMG metrics
EMG metrics (amplitude (Volts), latency (seconds), duration (seconds) and area under the curve (volts·second)) of the recordings using the AcqKnowledge 4.4 software (BIOPAC Systems, USA) will be analyzed and combined to describe the electromyographic response of the suprahyoid muscles.
Measured: Post intervention in visit 1 (baseline)
Pre visit 2 Spontaneous swallowing frequency (SSF)
SSF will be measured with surface neck electromyography (sEMG) and accelerometry for 10min, in which the patient will be asked to breathe normally and to remain calm and quiet. sEMG electrodes will be placed over the digastric-mylohyoid complex and an omnidirectional accelerometer over the cricothyroid cartilage to assess the number of swallows per minute.
Measured: Pre intervention visit 2 (1 week after)
Pre visit 2 EMG metrics
EMG metrics (amplitude (Volts), latency (seconds), duration (seconds) and area under the curve (volts·second)) of the recordings using the AcqKnowledge 4.4 software (BIOPAC Systems, USA) will be analyzed and combined to describe the electromyographic response of the suprahyoid muscles.
Measured: Pre intervention visit 2 (1 week after)
Post visit 2 Spontaneous swallowing frequency (SSF)
SSF will be measured with surface neck electromyography (sEMG) and accelerometry for 10min, in which the patient will be asked to breathe normally and to remain calm and quiet. sEMG electrodes will be placed over the digastric-mylohyoid complex and an omnidirectional accelerometer over the cricothyroid cartilage to assess the number of swallows per minute.
Measured: Post intervention visit 2 (1 week after)
Post visit 2 EMG metrics
EMG metrics (amplitude (Volts), latency (seconds), duration (seconds) and area under the curve (volts·second)) of the recordings using the AcqKnowledge 4.4 software (BIOPAC Systems, USA) will be analyzed and combined to describe the electromyographic response of the suprahyoid muscles.
Measured: Post intervention visit 2 (1 week after)

Secondary outcomes (2)

Volume-viscosity swallowing test (V-VST)
The V-VST is an effort test in which boluses of increasing volume and viscosity are administered to check for clinical signs of impaired efficacy and safety in each swallow. V-VST is designed to protect patients from aspiration by starting with 250 mPa•s viscosity and increasing volumes from 5 ml, to 10 ml and 20 ml boluses. When patients have completed the 250 mPa•s series without major symptoms of aspiration, a less safe liquid viscosity series will be assessed. Finally, a safer 800 mPa•s viscosity series will be assessed in the same way. If the patient presents signs of impaired safety at 250 mPa•s viscosity, the series will be interrupted, the <50 mPa•s viscosity series will be omitted, and a safer 800 mPa•s viscosity series will be assessed. If the patient presents signs of impaired safety at <50 mPa•s viscosity, the liquid series will be interrupted, and the 800 mPa•s series will be assessed.
Measured: Pre and Post treatment in visit 1 (baseline) and visit 2 (1 week after)
Concentration of salivary neuropeptides
Saliva samples will be collected using the Salivette® technique, by putting a swab under the tongue for 5 min. Samples will be stored at -80ºC until their analysis. The concentration of salivary neuropeptides substance P (SP) and calcitonin gene-related peptide (CGRP) will be determined by using 2 specific commercial Enzyme-Linked ImmunoSorbent Assay (ELISA) kits: Substance P Parameter Assay Kit (R\&D systems, USA) and CGRP (Human) ELISA kit (Abnova, Taiwan).
Measured: Pre and Post treatment in visit 1 (baseline) and visit 2 (1 week after)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202331 Jan 2025

First posted9 Feb 2024
Study start21 Oct 2023
Primary completion31 Jan 2025 (estimated)
Study completion31 Jan 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Oropharyngeal DysphagiaStudies 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: Crossover
Model description: Randomized, crossover, interventional and, open-label clinical study. The study includes 2 groups: 1) n=25: 1st visit: stimulation with Control, 2nd visit: stimulation with CS; and 2) n=25: 1st visit: stimulation with CS, 2nd visit: stimulation with Control.
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06250426
Sponsor's protocol ID: Refresh
Status last verified: Jan 2024
First submitted: 6 Jul 2023
Last updated: 9 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tomsen N, Espano D, Nunez-Lara A, Clave P. An oral nutritional supplement with TRPM8 agonists as a cooling flavor improved swallowing function in post-stroke patients with oropharyngeal dysphagia. Sci Rep. 2026 Jun 19;16(1):28505. doi: 10.1038/s41598-026-58808-0.
PubMed 42321377

Want to know more?

Pere Clavé, MD, PhD

937417700 ext. 2284

pere.clave@ciberehd.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Oropharyngeal Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REFRESH Study: Therapeutic Effect of a Cooling Sensation Flavor in Pre-thickened ONS Products on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia
ClinicalTrials.gov ID: NCT06250426
Acronym / sponsor ID: Refresh
Conditions: Oropharyngeal Dysphagia, Stroke, Swallowing Disorder
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Hospital de MataróUniversity, hospital or other
Collaborators: Nutricia Research
Study start: 21 Oct 2023 (actual)
Primary completion: 31 Jan 2025 (estimated)
Study completion: 31 Jan 2025 (estimated)
First posted: 9 Feb 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Randomized, crossover, interventional and, open-label clinical study. The study includes 2 groups: 1) n=25: 1st visit: stimulation with Control, 2nd visit: stimulation with CS; and 2) n=25: 1st visit: stimulation with CS, 2nd visit: stimulation with Control.

Arm	Type	Receives
Active	Active comparator	Dietary Supplement: Pre-thickened oral nutritional supplement with a cooling sensation flavourPre-thickened oral nutritional supplement with a cooling sensation flavour
Control	Placebo comparator	Dietary Supplement: Pre-thickened oral nutritional supplement without a cooling sensation flavourPre-thickened oral nutritional supplement without a cooling sensation flavour

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥18 years
Patients with chronic OD as a consequence of stroke (more than 3 month since stroke diagnostic)
Patients with impaired safety and/or efficacy of swallow (V-VST)
Patients that can swallow safely the investigation and control product according to the viscosity of the product and the results of the V-VST
Patients able to follow the protocol and give informed consent

Key exclusion criteria (7 listed)

Pregnancy
Life expectancy <3 months or palliative care
OD diagnosis prior to stroke
Dementia (GDS 4 or higher)
Allergy to the investigation and/or control product or to any of its components

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
Pre-thickened oral nutritional supplement with a cooling sensation flavourPre-thickened oral nutritional supplement (ONS) drink with cooling sensation flavour	Dietary supplement	Active
Pre-thickened oral nutritional supplement without a cooling sensation flavourPre-thickened oral nutritional supplement (ONS) drink without cooling sensation flavour	Dietary supplement	Control

Primary outcome

Pre visit 1 Spontaneous swallowing frequency (SSF)
Time frame: Pre intervention in visit 1 (baseline)
SSF will be measured with surface neck electromyography (sEMG) and accelerometry for 10min, in which the patient will be asked to breathe normally and to remain calm and quiet. sEMG electrodes will be placed over the digastric-mylohyoid complex and an omnidirectional accelerometer over the cricothyroid cartilage to assess the number of swallows per minute.
Pre visit 1 EMG metrics
Time frame: Pre intervention in visit 1 (baseline)
EMG metrics (amplitude (Volts), latency (seconds), duration (seconds) and area under the curve (volts·second)) of the recordings using the AcqKnowledge 4.4 software (BIOPAC Systems, USA) will be analyzed and combined to describe the electromyographic response of the suprahyoid muscles.
Post visit 1 Spontaneous swallowing frequency (SSF)
Time frame: Post intervention in visit 1 (baseline)
SSF will be measured with surface neck electromyography (sEMG) and accelerometry for 10min, in which the patient will be asked to breathe normally and to remain calm and quiet. sEMG electrodes will be placed over the digastric-mylohyoid complex and an omnidirectional accelerometer over the cricothyroid cartilage to assess the number of swallows per minute.
Post visit 1 EMG metrics
Time frame: Post intervention in visit 1 (baseline)
EMG metrics (amplitude (Volts), latency (seconds), duration (seconds) and area under the curve (volts·second)) of the recordings using the AcqKnowledge 4.4 software (BIOPAC Systems, USA) will be analyzed and combined to describe the electromyographic response of the suprahyoid muscles.
Pre visit 2 Spontaneous swallowing frequency (SSF)
Time frame: Pre intervention visit 2 (1 week after)
SSF will be measured with surface neck electromyography (sEMG) and accelerometry for 10min, in which the patient will be asked to breathe normally and to remain calm and quiet. sEMG electrodes will be placed over the digastric-mylohyoid complex and an omnidirectional accelerometer over the cricothyroid cartilage to assess the number of swallows per minute.
Pre visit 2 EMG metrics
Time frame: Pre intervention visit 2 (1 week after)
EMG metrics (amplitude (Volts), latency (seconds), duration (seconds) and area under the curve (volts·second)) of the recordings using the AcqKnowledge 4.4 software (BIOPAC Systems, USA) will be analyzed and combined to describe the electromyographic response of the suprahyoid muscles.
Post visit 2 Spontaneous swallowing frequency (SSF)
Time frame: Post intervention visit 2 (1 week after)
SSF will be measured with surface neck electromyography (sEMG) and accelerometry for 10min, in which the patient will be asked to breathe normally and to remain calm and quiet. sEMG electrodes will be placed over the digastric-mylohyoid complex and an omnidirectional accelerometer over the cricothyroid cartilage to assess the number of swallows per minute.
Post visit 2 EMG metrics
Time frame: Post intervention visit 2 (1 week after)
EMG metrics (amplitude (Volts), latency (seconds), duration (seconds) and area under the curve (volts·second)) of the recordings using the AcqKnowledge 4.4 software (BIOPAC Systems, USA) will be analyzed and combined to describe the electromyographic response of the suprahyoid muscles.

2 secondary outcomes

Volume-viscosity swallowing test (V-VST)
Time frame: Pre and Post treatment in visit 1 (baseline) and visit 2 (1 week after)
Concentration of salivary neuropeptides
Time frame: Pre and Post treatment in visit 1 (baseline) and visit 2 (1 week after)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
Derived from this study: PubMed 42321377Tomsen N, Espano D, Nunez-Lara A, Clave P. An oral nutritional supplement with TRPM8 agonists as a cooling flavor improved swallowing function in post-stroke patients with oropharyngeal dysphagia. Sci Rep. 2026 Jun 19;16(1):28505. doi: 10.1038/s41598-026-58808-0.
Individual participant dataSharing planned: No

Related trials for Oropharyngeal Dysphagia

RecruitingObservational study
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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. This study is not recruiting at the moment.

Pere Clavé, MD, PhD contact

937417700 ext. 2284

pere.clave@ciberehd.org

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pere Clavé, MD, PhD (937417700 ext. 2284, pere.clave@ciberehd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre visit 1 Spontaneous swallowing frequency (SSF) (time frame: Pre intervention in visit 1 (baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06250426, which also lists 1 linked publication.

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 9 Feb 2024.