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Oropharyngeal Dysphagia 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: 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: 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: NCT05421689 Recruiting - Clinical trials for Oropharyngeal Dysphagia

Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia

Start date: May 26, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety of AMDC-GIR during the 24 months following 2 consecutive treatments of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.

NCT ID: NCT05278039 Recruiting - Clinical trials for Head and Neck Cancer

Training Swallowing Initiation During Expiration

Start date: August 12, 2021
Phase: N/A
Study type: Interventional

Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.

NCT ID: NCT04695600 Recruiting - Clinical trials for Oropharyngeal Dysphagia

Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia

Start date: August 22, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Dysphagia in patients with stroke, multiple sclerosis, parkinsonism or dystonia can occur due to relative hypertonia of the cricopharyngeus muscle. In the resting state, muscle is contracted and relaxes only during deglutition. Treatment of dysphagia by injecting botulinum toxin in the cricopharyngeus was described by Schneider et al. in 1994. More than 100 cases have been described after that, however there are no randomized controlled trials. A meta-analysis from Cochrane has also concluded that there is no sufficient evidence to conclude regarding the efficacy and safety of Botulinum toxin injection in cricopharyngeal dysfunction. So this study is necessary to fill this void in knowledge

NCT ID: NCT04581486 Recruiting - Malnutrition Clinical Trials

Effectiveness of an Optimal-Massive Intervention in Older Patients With Dysphagia

OMI
Start date: June 6, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the efficacy of an optimal-massive intervention (OMI) based on increasing shear viscosity of fluids, nutritional support with oral nutritional supplements (ONS) and triple adaptation of food (rheological and textural, caloric and protein and organoleptic) and oral hygiene improvement on the incidence of respiratory infections in older patients with OD. We have designed a randomized clinical trial, with two parallel arms and 6 months follow-up. The study population will be constituted by older patients of 70 years or more with OD hospitalized at Hospital de Mataró by an acute process that will be identified by using the volume-viscosity swallow clinical test. We will consecutively recruit 500 subjects during admission (Geriatrics, Internal medicine, etc.) at the Hospital de Mataró. Patients included will be randomly assigned to one of both interventional groups: a) study intervention: multifactorial intervention based on fluid viscosity adaptation (with a xanthan gum thickener -> Nutilis Clear®), nutritional support with a triple adaptation of food (texture, caloric and protein content, organoleptic) + pre-thickened ONS and evaluation and treatment of oral hygiene (tooth brushing + antiseptic mouthwashes + professional dental cleaning), or b) control intervention: standard clinical practice (fluid adaptation with Nutilis Powder and simple texture adaptation for solids). Main outcome measures: respiratory infection incidence during the 6-month period follow-up. Secondary outcomes: mortality at 6 months, general hospital readmissions and readmissions due to respiratory infections, nutritional status, hydration status, quality of life, functional status, oral hygiene and dysphagia severity and its relationship with other study variables.

NCT ID: NCT04477460 Recruiting - Clinical trials for Oropharyngeal Dysphagia

Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event

BRUE
Start date: April 1, 2021
Phase:
Study type: Observational

This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

NCT ID: NCT04359199 Recruiting - Clinical trials for Head and Neck Cancer

QUantitative Assessment of Swallowing After Radiation (QUASAR)

QUASAR
Start date: September 1, 2020
Phase:
Study type: Observational

To use novel methods for quantitative analysis of VFSS (videofluoroscopic swallow study, also known as modified barium swallow) to study and compare dysphagia in patients treated for head and neck carcinoma with concurrent radiation therapy and chemotherapy (cisplatin) or targeted therapy (cetuximab) vs. immunotherapy (pembrolizumab, nivolumab, or durvalumab). Our hypothesis is that pharyngeal constriction will be greater (lower ratio) with concurrent immunotherapy compared to chemotherapy, as measured by the pharyngeal constriction ratio (PCR).

NCT ID: NCT04130867 Recruiting - Clinical trials for Oropharyngeal Dysphagia

Rehabilitation Manometry Study

Start date: November 11, 2020
Phase:
Study type: Observational

Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function. This proposed project will address a central hypotheses that objective swallowing measures (including (pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment. The investigators will follow a cohort of participants with oropharyngeal dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6 weeks) and post-treatment (10-12 weeks). The investigators will compare participants to healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.