Dysphagia

Background: Eosinophilic esophagitis (EoE) is a disease that causes inflammation in the esophagus. The esophagus is the tube that moves food from the mouth to the stomach. Diagnosing EoE currently requires a specialized tool called an endoscope. The esophageal string test (EST) is another test; the EST collects fluid from the upper digestive tract. An EST is simpler and cheaper than an endoscopy. Researchers want to know if an EST can diagnose EoE. Objective: To test if the EST can diagnose EoE in people who have trouble swallowing. Eligibility: Adults aged 18 to 65 years with trouble swallowing. They must have been born in the African continent or their parents were born in Africa. Design: Participants will be screened. They will give blood, stool, urine, and skin swab samples. They will complete surveys about their medical history, diet, symptoms, and home environment. They will bring a sample of their drinking water for testing. Participants will have an EST. They will swallow a pill capsule that contains a nylon string. One end of the string will be taped to their cheek. The string will unravel down the esophagus and into the stomach. It will be pulled out after 1 hour. Fluids that soaked into the string will be tested. At a different visit, participants will have an endoscopic exam. An endoscope is a flexible tube that is inserted down the mouth; it can be used to take tissue samples from the esophagus, stomach, and small intestine. Participants will have a final visit in person, online, or by phone. They will take a survey and talk about their test results.

This research study is investigating the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Currently, no targeted, effective, and feasible dysphagia treatment approaches currently exist for use in critically ill adults in the acute care setting. The current study will investigate the impact of EMST, standard of care dysphagia treatment, and intensive dysphagia treatment on pulmonary function, cough function, swallow function, frailty, patient-reported swallow function, and health outcomes in critically ill adults. This study will also examine patient perceptions and clinical speech-language pathologists' perceptions of the acceptability, appropriateness, and feasibility of these interventions. Critically ill adults will: undergo tests of breathing, cough, and swallow function, complete questionnaires about the treatment, and their swallow function, and complete their respective treatment as prescribed. Clinical speech-language pathologists will complete questionnaires about the interventions. A subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.

Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.

This study aims to directly compare and contrast swallowing pressure and impedance measurements obtained from two high-resolution manometry (HRM) systems: the Laborie LMT Pharyngeal System and the Medtronic ManoScan ESO HRM System in healthy adult volunteers. The primary objective is to determine how differences in catheter diameter, sensor configuration, and acquisition platforms influence measurement outcomes. Twenty-five healthy adults will participate in a single, approximately 2-hour visit; the study will be open for one year for data collection and two years for data analysis.

The purpose of this study is to evaluate the safety and potential benefits of combining deep brain stimulation (DBS) with targeted speech and swallowing rehabilitation in individuals who have experienced a stroke and have moderate to severe difficulties with speech and/or swallowing. Speech difficulties may include apraxia, which affects the ability to plan and coordinate speech movements, and dysarthria, which affects the ability to produce clear speech. Participants may also have difficulty swallowing (dysphagia). The primary objective of this feasibility study is to evaluate the safety of the SR-DBS system in individuals with post-stroke speech and swallowing difficulties. The secondary objective is to evaluate whether combining DBS with speech and swallowing rehabilitation improves motor speech and swallowing function and reduces related impairments. The study will compare outcomes following rehabilitation alone with outcomes following rehabilitation combined with DBS to determine whether the addition of DBS provides greater improvements in speech and swallowing function.

Difficulty swallowing (called dysphagia) is common in older adults and can make eating and drinking unsafe. It may lead to serious problems such as choking, lung infections, poor nutrition, and reduced quality of life. One common way to reduce these risks is to modify food and drink textures (for example, making foods softer or liquids thicker). However, people often find it difficult to prepare food at the correct texture level in everyday life, especially at home, which may reduce the effectiveness of this approach. This study aims to test whether an artificial intelligence (AI)- powered smartphone application can help older adults with swallowing difficulties eat more safely. The app allows users (or their caregivers) to take a photo of food or drinks, then estimates the texture level and provides guidance to help them follow their recommended food texture level. It also gives simple prompts to double-check food texture when needed. The app is intended as a decision-support tool and does not replace clinical advice or prescribed dietary recommendations. In this clinical trial, community-dwelling adults aged 60 years or above with swallowing difficulties will be randomly assigned to one of two groups. One group will receive usual care, which includes education about safe swallowing and written instructions on appropriate food textures. The other group will receive the same usual care plus access to the AI-enabled mobile app for 12 weeks. Participants will continue their daily eating routines at home. Participants will also be followed for an additional 8 weeks after the 12-week intervention period. The main question this study aims to answer is: Does using the AI-enabled mobile app increase the frequency with which people eat foods that match their recommended safe texture level compared with usual care alone? This will be assessed at Week 12 using a structured 3-day dietary record and accompanying meal photographs. The study will also examine whether the app helps reduce swallowing-related symptoms and adverse events, improves swallowing-related quality of life, and increases confidence in managing swallowing difficulties. In addition, the study will evaluate how easy the app is to use and whether it places any burden on users. Hypothesis: Participants who use the AI-enabled app, in addition to usual care, will more consistently follow recommended food texture guidelines than those who receive usual care alone.

Dysphagia can reach a prevalence of up to 80% in intensive care patients. The implementation or prolonged presence of medical devices such as the intubation tube, tracheostomy, or nasogastric tube alters the physiology of swallowing and causes local injuries at several levels. Additionally, certain medical treatments impair swallowing physiology and the patient's alertness, further promoting the development of these disorders. Management of dysphagia involves two main types of strategies: adaptive or compensatory maneuvers and rehabilitation techniques such as: performing praxis or swallowing exercises; physical stimulation (tactile or thermal); transcranial stimulation (electrical or magnetic); and finally, pharyngeal or transcutaneous electrical stimulation (NMES). Patients hospitalized in intensive care often present with altered levels of alertness, asynchronous ventilation and swallowing, and reduced motor capabilities, making it difficult to perform techniques like praxis, food trials, or resistance swallowing exercises. NMES does not require active patient cooperation or the permanent presence of the therapist during the stimulation session, thus increasing the intensity of dysphagia rehabilitation and the early implementation of treatment in these patients, complementing conventional rehabilitation. Muscle and sensory stimulation through the application of NMES can help increase the strength of the muscles involved in swallowing and improve sensory capabilities. However, its effects have not yet been evaluated in tracheostomized patients undergoing weaning from prolonged mechanical ventilation.

Swallowing difficulties are extremely common and result in substantial morbidity, reduction in the quality of life, and mortality related to malnutrition and complications from regurgitation and aspiration. Unfortunately, our understanding regarding the pathophysiology of dysphagia and GERD has been hampered by focusing predominantly on circular muscle activity and ignoring the essential biomechanical properties of the esophageal wall that promote normal emptying. Our initial work explored the relationship between intrabolus pressure (IBP) and esophagogastric junction (EGJ) compliance as a metric for outflow resistance. This work highlighted the direct relationship between IBP and EGJ opening and was the foundation for the development of the classification scheme utilized around the world to diagnose esophageal motor disorders: "the Chicago Classification" (CC). Despite this improved understanding focused on bolus transit dynamics, there are still significant gaps in our scientific understanding centered on the lack of a true correlate for symptoms, reliable predictive models and effective treatments for Functional dysphagia, IEM and EGJOO. Given these limitations, we have developed novel approaches that combine assessments of primary and secondary peristalsis (a NeuroMyogenic Model of esophageal function). These will leverage our recent findings supporting the importance of the esophageal response to distension in bolus clearance, noting that this response of the esophageal wall to bolus retention or reflux is one of the most essential functions of the esophagus in preventing complications of aspiration, or reflux injury. We will also include an assessment of esophageal geometry and wall biomechanics (elasticity/dilatation) as these carry essential interactions with esophageal function that are overlooked in the current diagnostic paradigms. In order to test our hypothesis that wall mechanics are a major determinant of esophageal diseases, we had to develop new approaches and new technology to directly measure mechanical wall state, descending inhibition and LES opening. Using impedance techniques combined with manometry, we are now capable of assessing IBP and diameter changes across a space-time continuum (4D HRM). We also developed physics-based hybrid diagnostics that include a FLIP technique to assess esophageal work and power during volumetric distention (FLIP-MECH) and a fluoroscopy approach that simultaneously assesses esophageal diameter-pressure relationships (Fluoro-MECH). We also developed a new approach, Interactive FLIP Panometry, which facilitates an assessment of descending inhibition and the mechanism behind impaired LES opening. These tools will allow us to expand our models to combine an assessment of neuromyogenic function simultaneously with geometry. Our overarching goal will be to study well-defined patient populations (Functional Dysphagia, IEM/GERD, EGJOO and Achalasia) before and after targeted interventions to test the NeuroMyogenic and MechanoGeometric Model. This work will build upon the previous success of the CC and help advance the evolution of the CC by defining new, relevant biomechanical physiomarkers of disease activity that can identify new targets for therapeutic intervention and facilitate prediction of clinical outcomes.

This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation. Participants will: * undergo tests of breathing, cough, and swallow function * complete questionnaires about the treatment, their swallow function * complete breathing exercises daily

Dysphagia, or difficulty swallowing, is a common symptom of many neurological diseases but its treatment is not well established or easily accessible. To start addressing this gap, the researchers developed and validated a cost-effective wearable surface electromyography (sEMG) biofeedback sensor technology (i-Phagia), optimized to record muscle activity from the head/neck and provide biofeedback to patients and adherence data to clinicians during swallow therapy. This system has been developed with commercially available and widely used materials and the Purdue University IRB has determined that the device is non-significant risk device. The goal of this clinical trial is to learn if this biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease. It will also help the investigators learn whether this therapy protocol is equally effective when provided in-person versus via telehealth. Finally, it will determine which patient factors may influence how well the treatment works. The main questions it aims to answer are: * Does biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works better than a standard of care treatment to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease? * Is completing the swallow therapy protocol at home (via telehealth) as effective as completing it in-person (in the clinic)? * What factors related to the patients (e.g., age, diagnosis, etc.) may influence how well the treatment works? Participants will: * Complete a 12-week swallow treatment protocol (12 treatment visits) either in-person or at home (via telehealth) * Complete 3 in-person evaluations (pre-treatment; post-treatment; and at a 12-week post treatment follow-up time point) * Exercise at home several days per week and keep a diary/log of their home exercise The hypothesis is that upon study completion, the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations will have been established, and variables determining response to treatment will begin to be identified.

This prospective observational cohort study aims to compare the safety and clinical outcomes of sedated and unsedated percutaneous endoscopic gastrostomy procedures in elderly patients classified as ASA IV. The primary outcome is the development of cardiopulmonary complications within the first 24 hours after the procedure. Secondary outcomes include technical success, procedure duration, early procedure-related complications, length of hospital stay, intensive care requirement, 30-day mortality, and 30-day readmission.

The goal of this clinical trial is to learn whether a tongue endurance exercise program can improve swallowing function in adults with dysphagia after a stroke. It also aims to explore how this exercise may affect brain structure and connectivity involved in swallowing. The main questions it aims to answer are: Primary Aim: Does lingual endurance exercise improve swallowing function compared to a sham therapy? Secondary Aim: Does lingual endurance exercise lead to changes in brain structure or neuroplasticity, as measured by MRI? Researchers will compare a group receiving tongue endurance exercises to a sham therapy group to see whether the treatment improves tongue function, swallowing. Participants will: * Complete a baseline swallowing assessment and MRI * Be randomly assigned to either the lingual exercise or sham therapy group * Complete 8 weeks of home-based tongue exercise therapy * Return for follow-up swallowing assessments * A subgroup of participants will complete a pre-treatment and post-treatment MRI.

This study evaluates the safety, feasibility, and preliminary effects of transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol in infants with severe dysphagia. Infants with significant sucking and swallowing impairment will receive twice-daily taVNS paired with oromotor training over a three-week period. Outcomes include swallowing mechanics, sucking proficiency, and functional feeding performance assessed before and after the intervention.

Post-stroke dysphagia is a common complication of stroke and may lead to impaired oral intake, malnutrition, aspiration, and pneumonia. Reduced tongue strength and tongue pressure are important contributors to impaired swallowing after stroke. Conventional tongue-pressure resistance training may improve tongue strength, but traditional training provides limited real-time feedback and may be difficult to individualize.This prospective, multicenter, randomized, open-label, parallel-controlled trial will evaluate the effectiveness of digital intelligent tongue-pressure biofeedback resistance training in patients with post-stroke dysphagia. A total of 80 participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group. Participants in the intervention group will receive digital intelligent tongue-pressure biofeedback resistance training in addition to conventional swallowing rehabilitation, while participants in the control group will receive conventional rehabilitation without the digital biofeedback intervention. The intervention period will last 2 weeks.Swallowing function will be assessed at baseline and after completion of the intervention. The primary outcome is the change in Functional Oral Intake Scale (FOIS) score. Secondary assessments include maximum tongue pressure and quantitative videofluoroscopic swallowing study (VFSS) measures, including oral transit time, Penetration-Aspiration Scale score, and pharyngeal residue. The study aims to determine whether digital intelligent tongue-pressure biofeedback resistance training provides additional benefits for swallowing function, tongue strength, and swallowing safety in patients with post-stroke dysphagia.

Dysphagia and sarcopenia are common complications in critically ill patients and are associated with increased morbidity, prolonged hospitalization, nutritional complications, and poorer clinical outcomes. Muscle ultrasound is a non-invasive bedside technique that may provide objective information on muscle mass and help identify patients at increased risk of these conditions. This single-center observational diagnostic accuracy study will evaluate the association between masseter muscle thickness measured by ultrasound and the presence of dysphagia in critically ill adult patients after extubation and in patients with a tracheostomy. Dysphagia will be assessed using the Modified Volume-Viscosity Swallow Test (MECVVm). Ultrasound measurements of the masseter and rectus femoris muscles will also be evaluated to investigate their relationship with sarcopenia and relevant clinical outcomes. The study aims to determine the diagnostic performance of masseter muscle ultrasound for identifying dysphagia, establish ultrasound cut-off values associated with dysphagia and sarcopenia, and explore whether these measurements may facilitate early risk stratification in critically ill patients.

This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.

This randomized, double-blind, sham-controlled clinical trial will investigate the effects and potential neural mechanisms of pharyngeal air-pulse sensory stimulation in patients with post-stroke dysphagia. A total of 80 participants with swallowing impairment after stroke will be randomly assigned in a 1:1 ratio to either an active stimulation group or a sham stimulation group. Both groups will receive conventional swallowing rehabilitation, while the active group will additionally receive pharyngeal air-pulse sensory stimulation and the control group will receive sham stimulation for 2 weeks. Swallowing function and neurophysiological changes will be assessed before and after the intervention. Assessments will include clinical swallowing evaluations, videofluoroscopic swallowing study, surface electromyography, resting-state and task-based functional magnetic resonance imaging, and diffusion kurtosis imaging. The study aims to determine whether pharyngeal air-pulse sensory stimulation can improve swallowing function and to explore associated changes in swallowing-related sensory-motor brain networks after stroke.

The purpose of this study is the development and early-stage validation of a wearable sensor for dysphagia in patients with PD.

This is a prospective, single-center, crossover study comparing EndoFLIP measurements obtained in two patient positions, supine and left lateral decubitus, in pediatric and young adult patients. The Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is an FDA-approved device for patients aged 5 and older that utilizes high-resolution impedance planimetry and volume-controlled distension to assess esophagogastric junction function. Currently, no standardized positioning protocol exists, and proceduralists perform EndoFLIP based on individual preference, either supine or left lateral decubitus. This variability may introduce measurement inconsistencies, particularly when comparing preoperative and postoperative assessments performed in different positions.

The goal of this clinical study is to learn if an artificial intelligence (AI)-assisted swallowing rehabilitation program can improve swallowing function in adults with dysphagia. It will also learn whether this approach can better detect aspiration (food or liquid entering the airway) and improve eating ability. The main questions it aims to answer are: Can AI-assisted analysis help identify swallowing treatment parameters that improve swallowing right away? Does an optimized AI-assisted swallowing treatment work better than standard treatment parameters over 6 weeks? Can AI using data from sensors detect aspiration accurately? Researchers will compare swallowing function before and after treatment. They will also compare optimized treatment parameters selected with AI and FEES (a camera-based swallowing test) with standard treatment parameters. In addition, researchers will compare AI model results with FEES findings to see how well the sensors can identify aspiration. Participants will: Complete swallowing assessments, including FEES, drinking tests, and swallowing questionnaires. Have small sensors placed to record muscle activity, sound, oxygen levels, and breathing while swallowing. Receive swallowing rehabilitation over 6 weeks, with treatment given in 1-week periods. During each period, treatment will be randomly assigned as either optimized parameters or standard parameters. Complete swallowing assessments after treatment periods to measure changes in swallowing function and eating ability.

The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort. Researchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program. Participants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.

Esophageal cancer is the seventh most common type of cancer in the world, with an estimated global incidence of 604,100 new cases per year. The main symptom of esophageal cancer is dysphagia, associated or not with weight loss. Unfortunately, due to asymptomatic presentation in the early stages, more than half of patients are diagnosed in advanced stages of the disease, becoming ineligible for treatment with curative intent. In this sense, chemotherapy and radiotherapy are the pillars of palliative treatment, often regressing the injury and improving symptoms. However, some patients persist with dysphagia. In this scenario, esophageal prostheses are one of the main tools in the palliative treatment of esophageal cancer dysphagia, obtaining rapid and lasting relief of dysphagia. This study aims to compare fully covered (FC-SEMS) and partially covered (PC-SEMS) esophageal prostheses in this context, evaluating the number of reinterventions in each group, as well as the occurrence of adverse events. However, it is expected that with the data obtained it is possible to develop clearer and more effective protocols in the palliation of malignant dysphagia of esophageal stenosis.

The objective of of this observational study is to evaluate the nutritional status and the prevalence of nutrition-related conditions, as well as dysphagia, among patients aged 65 years and older with mental disorders. The study will also identify key associated factors and inform the development of targeted strategies for the prevention, early identification, and management of malnutrition and related conditions. Furthermore, a draft clinical pathway for nutritional care will be developed, and its feasibility and effectiveness will be assessed.

A retrospective, open-label, matched-control registry study designed to characterize the effectiveness of Pharyngeal Electrical Stimulation (PES) to improve swallowing in patients with severe dysphagia post stroke when delivered using the Phagenyx® System in real-world clinical settings in hospitals in the United States of America (US).

Dysphagia is a frequent complication following stroke, with an estimated prevalence of 42%. One training modality which have been implemented in both hospitals and municipalities for alleviating dysphagia are oral neuromuscular training devices. These devices are hand-held acrylic devices which are inserted between the lips and teeth by the patient or an assistant and pulled forward against lip pressure. According to the developers of one of these devices coined IQoro, the training strengthens the orofacial and pharyngeal muscles. One of recent studies by the developer of IQoro, have demonstrated a positive effect of IQoro in improving swallowing function and reducing clinical signs of aspiration among older people in intermediate care. However, aspiration risk was based on unblinded subjective water swallowing tests, and findings may therefore be biased. Additionally, it should be considered that the study was a cluster-randomized study, in which the intervention was performed in some care units, and the usual care was performed in other care units. Since usual care is not described in detail, results in favor of IQoro may also be due to differences in the usual care practice between care units. Focusing on individuals with stroke, only observational studies have been carried out. These studies have shown functional improvements in all four quadrants of the mouth, improved lip strength, and improved swallowing capacity. However, observational studies suffer from the inherent limitation that it is not possible to establish whether training with IQoro is actually the cause of these improvements. The present research group recently published a small Randomized Controlled Trial (RCT), investigating the effectiveness of IQoro on swallowing function and decannulation in a very selective population of patients with cuffed tracheostomies due to severe acquired brain injury . Here, 22 subjects were randomized to either usual care, or usual care plus IQoro training as an add-on. In the study, there was no effect of IQoro in either time until decannulation, or swallowing function (as the implicit mechanism of action), compared with usual care. Patients with cuffed tracheostomy tubes are a very selective patient group, and results may not be generalized to a broader group of patients with post-stroke dysphagia. Based on this, more high-quality clinical trials with IQoro, on a broader population of patients with dysphagia admitted for neurorehabilitation is warranted, in order to clarify whether training with IQoro have an effect on swallowing. Aim and hypothesis The aim of this study is to investigate the effectiveness of oral neuromuscular training with IQoro on swallowing function in patients with dysphagia due to stroke. The hypothesis is that patients will have improved swallowing function because of training with IQoro as an add-on to usual care, compared with patients who only receive usual care. Study design An assessor-blinded randomized controlled trial. Study participants will be randomly assigned to either the IQoro (intervention group) or usual care (control group). The trial will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and approved by the Danish National Medical Research Ethics Committee