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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pre visit 1 Spontaneous swallowing frequency (SSF)
研究概览
简要总结
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®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
Active
Pre-thickened oral nutritional supplement with a cooling sensation flavour
干预措施: Pre-thickened oral nutritional supplement with a cooling sensation flavour (Dietary Supplement)
Control
Pre-thickened oral nutritional supplement without a cooling sensation flavour
干预措施: Pre-thickened oral nutritional supplement without a cooling sensation flavour (Dietary Supplement)
结局指标
主要结局
Pre visit 1 Spontaneous swallowing frequency (SSF)
时间窗: 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.
Post visit 1 Spontaneous swallowing frequency (SSF)
时间窗: 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.
Pre visit 1 EMG metrics
时间窗: 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.
Pre visit 2 EMG metrics
时间窗: 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 EMG metrics
时间窗: 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.
Pre visit 2 Spontaneous swallowing frequency (SSF)
时间窗: 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.
Post visit 2 Spontaneous swallowing frequency (SSF)
时间窗: 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 1 EMG metrics
时间窗: 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.
次要结局
- 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))
研究者
Pere Clave
Principal Investigator
Hospital de Mataró