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Swallowing Disorder clinical trials

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NCT ID: NCT06250426 Recruiting - Stroke Clinical Trials

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

Start date: October 21, 2023
Phase: N/A
Study type: Interventional

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®.

NCT ID: NCT06163118 Recruiting - Dysphagia Clinical Trials

Validation of a Screening Tool for Swallowing Disorders for the Elderly

DéGluT'G
Start date: December 12, 2023
Phase: N/A
Study type: Interventional

Swallowing disorder, or dysphagia, is a lack of protection of the airways during the passage of the food bolus towards the esophagus. Swallowing disorder is characterized by a feeling of discomfort when swallowing, difficult swallowing in elderly people or a blockage felt during the progression of food between the mouth and the stomach, sometimes with falsities. These disorders can be the cause of a loss of appetite and a reduction in food consumption in older people. In the most serious cases, they can lead to aspiration, weakening the pulmonary passages and possibly leading to suffocation. Swallowing disorders constitute an important public health problem due to their prevalence among the elderly. Many early readmissions could be avoided thanks to better quality of care in these patients. In the elderly, the number of comorbidities and the multiplicity of medications and drug intake increase the incidence of swallowing disorders in this population. They constitute a common pathology, probably underestimated and underdiagnosed in the geriatric population. Given the aging of the Martinique population, it is appropriate to offer an easy-to-use, quickly achievable tool for diagnostic purposes, making it possible to quickly identify potential swallowing disorders, and therefore to anticipate meal intake, and on the adaptation of the prescription to a medicinal alternative (before any food or medication taken during hospitalization). In the Geriatric Short-Stay Unit of the Martinique University Hospital, a tool called "Deglut'G", was developed, and has been used since 2015, in order to allow caregivers a rapid, reliable and relevant assessment of swallowing disorders in the elderly, in order to guide care and medication alternatives.It now appears important to validate this tool, by comparing it with the results of examinations of swallowing disorders obtained from a speech-language pathologists (SLPs) and an ENT doctor.

NCT ID: NCT05938166 Recruiting - Swallowing Disorder Clinical Trials

The Effects of Using Augmented Reality (AR) Simulation System to Train Foreign Care Workers.

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the effect of augmented reality (AR) simulation training intervention of foreign care workers on the oral function of older people. This randomized controlled trial included experimental group: AR group (EG) and control group(CG), respectively. The EG will receive augmented reality (AR) simulation training intervention with traditional classroom oral health education. The CG only receive traditional classroom oral health education.

NCT ID: NCT05905016 Recruiting - Gastroparesis Clinical Trials

Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders

POEM
Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

NCT ID: NCT05795569 Recruiting - Clinical trials for Deglutition Disorders

Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial

FIRST
Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Post-extubation dysphagia (PED) is a frequent but still underestimated condition in the intensive care units (ICU). In the international literature, the manifestations and consequences of PED lead to intra- and post-intensive care comorbidities. The exact etiology of PED is unknown, but considered multifactorial. Numerous causes, acquired during ICU, can lead to a delay in the reintroduction of intravenous nutrition, or even favor the development of inhalation pneumopathy. One of these causes is the presence of the nasogastric tube. The incidence of ECD varies from 3 to 62%. Its presence impacts morbidity and mortality. Preventive strategies for PED have only been studied with questionable methodologies. The goal of ICU therapists is to detect PED as early as possible in order to implement curative strategies such as adapted nutrition and early swallowing rehabilitation.

NCT ID: NCT05735626 Recruiting - Stroke Clinical Trials

Treatment of Acute Post-stroke Oropharyngeal Dysphagia With Paired Stimulation

ICI20/00117
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

According WHO, oropharyngeal dysphagia (OD) is a prevalent post-stroke (PS) condition involving the digestive system (ICD-10: I69.391) and an independent risk factor for malnutrition and pulmonary infection; and leads to greater morbimortality and healthcare costs and poorer quality of life (QoL). Currently, OD therapy is mainly compensatory, with low rates of compliance and small benefit, and there is no pharmacological treatment, so new treatments that improve patients' condition are crucial. PS-OD patients present both oropharyngeal sensory and motor deficits, so neurorehabilitation treatments which target both could be optimum. Benefits of paired peripheral sensory stimulation with oral capsaicin or piperine and of central motor noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) will be studied. Pairing sensory peripheral and central stimulation may produce greater benefits. The main aim of the project is to study the efficacy of a novel protocol of paired stimulation on acute PS-OD patients. The investigators will assess the acute application of tDCS/piperine or tDCS/capsaicin in the acute phase of stroke, will improve PS-OD. 2 days randomized crossover study with 60 patients in 3 treatment groups (60 patients in the acute stroke phase divided in 3 study arms). We will assess changes in swallow safety, and neurophysiology of the swallow, hospital stay, respiratory and nutritional complications, mortality and QoL.

NCT ID: NCT05734586 Recruiting - Swallowing Disorder Clinical Trials

Screening for Sarcopenic Dysphagia and the Implementation of Measures to Prevent Its Complications in Geriatric Patients [DYSPHAGING-PILOT]

DYSPHAGING-P
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Sarcopenic dysphagia is described as a swallowing disorder caused by a loss of muscle mass and strength, sarcopenia. It induces chronic complications like micro-inhalations and the worsening of chronic undernutrition, according to a vicious circle. Awareness of the high prevalence of sarcopenic dysphagia and its serious consequences among elderly people with disabilities and hospitalized patients is recent, which explains the low rate of screening in the population concerned. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most exposed population are needed. Two European learned societies have developed recommendations that include increased awareness of swallowing disorders, the use of screening scores, preventive measures, diagnostic standardization, and implemented interventions (rehabilitation, textural adaptation, etc.). In order to respect these recommendations, a pedagogical sheet, entitled DYSPHAGING was elaborated within our unit in a multiprofessional way in 4 steps (1 - Screen; 2 - Protect; 3 - Confirm; 4 - Rehabilitate). This feasibility study aims to evaluate the rate of completion and the conditions for implementing steps 1 and 2 in hospital and institutional care units.

NCT ID: NCT05733494 Recruiting - Dysphagia Clinical Trials

Cross Cultural Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration

Start date: April 5, 2022
Phase:
Study type: Observational

The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population. Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics. The present study aims to translate and validate the Italian version of CADN in neurodegenerative population. Psychometric properties will be measured.

NCT ID: NCT05720871 Recruiting - Stroke Clinical Trials

Treatment of Chronic Post-stroke Oropharyngeal Dysphagia With Paired Stimulation

ICI20/00117
Start date: November 28, 2022
Phase: N/A
Study type: Interventional

According WHO, oropharyngeal dysphagia (OD) is a prevalent post-stroke (PS) condition involving the digestive system (ICD-10: I69.391) and an independent risk factor for malnutrition and pulmonary infection; and leads to greater morbimortality and healthcare costs and poorer quality of life (QoL). Currently, OD therapy is mainly compensatory, with low rates of compliance and small benefit, and there is no pharmacological treatment, so new treatments that improve patients' condition are crucial. PS-OD patients present both oropharyngeal sensory and motor deficits, so neurorehabilitation treatments which target both could be optimum. Benefits of paired peripheral sensory stimulation with oral capsaicin and of central motor noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) will be studied. Pairing pharmacological peripheral and central stimulation may produce greater benefits. The main aim of the project is to study the efficacy of two novel protocols of paired stimulation on PS-OD patients. The investigators will assess whether 5-day application of tDCS/capsaicin or rTMS/capsaicin in the chronic phase of stroke, will improve PS-OD. One RCT (200 patients in the chronic stroke phase divided in 4 study arms) will assess changes in swallow safety, biomechanics and neurophysiology of the swallow response, hospital stay, respiratory and nutritional complications, mortality and QoL.

NCT ID: NCT05516693 Recruiting - Swallowing Disorder Clinical Trials

Chewing, Swallowing and Orofacial Motricity in Severe Obese

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Background: Obesity is considered an epidemic disease of great repercussion on the world and its prevalence has increased in recent decades. The treatment of obesity aims to improve health and quality of life, by reducing body weight. The clinical approach to obesity is routinely the first line of treatment. Clinical treatment usually involves a combination of restriction of caloric intake, modification of behavior and habits, regular practice of physical activity and pharmacotherapy. Clinical treatment of obesity leads to considerable weight loss, but often not sustained in most patients. This long-term sustained weight loss is an attribute of bariatric surgery, since severe obesity remains largely refractory to dietary and drug therapy. Changes in lifestyle that occur in severely obese patients undergoing bariatric surgery, especially in terms of food, lead to the need for the contribution of speech therapy to adapt to the new way of ingesting food. Objectives: to analyze the stomatognathic functions of mastication and swallowing and to verify the effectiveness of orofacial motricity stimulation in adults, severely obese before and after bariatric surgery. Methods: This is a randomized, controlled clinical trial involving severely obese adult patients of both sexes referred for bariatric surgery. This study was approved by the Research Ethics Committee of the Centro Universitário Fundação Assis Gurgacz (FAG) in the city of Cascavel (PR), Brazil, protocol number CEP FAG no. 4,169,295. Patients will be consecutively recruited from the Bariatric Surgery Department of Hospital São Lucas (FAG) and referred to the Speech Therapy Clinic according to the eligibility criteria of the research protocol. After the initial assessment, patients will be randomly assigned to an intervention group (MOG) and a control group (COG). The COG and MOG groups will be evaluated before and after bariatric surgery. Only the GMO will be submitted to the speech therapy training program before bariatric surgery. The myofunctional characteristics will be evaluated through the Orofacial Myofunctional Assessment protocol with Scores (AMIOFE). The AMIOFE protocol was designed according to the assessment models that reflect the physical characteristics and orofacial behaviors of individuals. In this way, the components and functions of the stomatognathic system will be evaluated in terms of appearance/posture, mobility and swallowing functions - liquid and solid - chewing and breathing.