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

NCT06250426 | Unknown

• 1 other identifier: Refresh
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Post intervention visit 2 (1 week after)

Secondary Outcomes (2)

• Volume-viscosity swallowing test (V-VST)

  Pre and Post treatment in visit 1 (baseline) and visit 2 (1 week after)

• Concentration of salivary neuropeptides

  Pre and Post treatment in visit 1 (baseline) and visit 2 (1 week after)

Other Outcomes (1)

• Characterization of the rheological properties of the study products

  Previous to the start of the clinical study

Study Arms (2)

Active

ACTIVE COMPARATOR

Pre-thickened oral nutritional supplement with a cooling sensation flavour

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

Dietary Supplement: Pre-thickened oral nutritional supplement without a cooling sensation flavour

Interventions

Pre-thickened oral nutritional supplement with a cooling sensation flavour DIETARY_SUPPLEMENT

Pre-thickened oral nutritional supplement (ONS) drink with cooling sensation flavour

Active

Pre-thickened oral nutritional supplement without a cooling sensation flavour DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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
• Current users of a pre-thickened ONS drink with cooling sensation flavor

Sponsors & Collaborators

• Hospital de Mataró: lead
• Nutricia Research: collaborator

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Pere Clavé, MD, PhD

CONTACT

937417700; pere.clave@ciberehd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: February 9, 2024
• Study Start: October 21, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)