An interventional study of Pre-thickened oral nutritional supplement with a cooling sensation flavour and Pre-thickened oral nutritional supplement without a cooling sensation flavour in Oropharyngeal Dysphagia, Stroke and Swallowing Disorder, sponsored by Hospital de Mataró. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Hospital de Mataró · Not applicable, Interventional, and Treatment
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®.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pre-thickened oral nutritional supplement with a cooling sensation flavour
Dietary Supplement: Pre-thickened oral nutritional supplement with a cooling sensation flavour
Pre-thickened oral nutritional supplement without a cooling sensation flavour
Dietary Supplement: Pre-thickened oral nutritional supplement without a cooling sensation flavour
Pre-thickened oral nutritional supplement (ONS) drink with cooling sensation flavour
Pre-thickened oral nutritional supplement (ONS) drink without cooling sensation flavour
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post intervention visit 2 (1 week after)
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.
Time frame: 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).
Time frame: Pre and Post treatment in visit 1 (baseline) and visit 2 (1 week after)
Characterization of the rheological properties of the study products
Determination of the viscosity in mPa•s at 50s-1 and the effect of the shear rate (viscosity at 50s-1 and at 300s-1) and alpha-amylase will be determine for both products. The rheological data will ensure the safety of the patients with OD during the study procedures.
Time frame: Previous to the start of the clinical study
Plan to share: No
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