Cooling flavor effect on swallowing in stroke patients with dysphagia
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
This study is testing whether a cooling flavored drink can help stroke patients with swallowing difficulties do so more safely and effectively compared to a regular drink.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Mataró Academic / other |
| Locations | 1 site (Mataró, Barcelona) |
| Trial ID | NCT06250426 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a cooling sensation flavor in pre-thickened oral nutritional supplements on the swallowing response of post-stroke patients suffering from oropharyngeal dysphagia. The study compares the swallowing safety and efficacy of a cooling flavored supplement against a non-flavored counterpart. It aims to enhance the treatment of dysphagia by potentially improving swallowing function while maintaining safety. Participants will be monitored for their ability to safely swallow both formulations, contributing to the understanding of innovative dysphagia management strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic oropharyngeal dysphagia resulting from a stroke that occurred more than three months prior.
Not a fit: Patients with a history of oropharyngeal dysphagia prior to stroke or those with severe dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve swallowing function and safety for patients with dysphagia, potentially reducing complications like aspiration pneumonia.
How similar studies have performed: While there have been studies on thickened fluids for dysphagia, the specific combination of cooling sensation flavors with thickened supplements is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥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 Exclusion Criteria: * 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
Where this trial is running
Mataró, Barcelona
- Hospital de Mataró — Mataró, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Pere Clavé, MD, PhD
- Email: pere.clave@ciberehd.org
- Phone: 937417700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.