Dysphagia

Researchers are developing and validating a wearable sensor designed to help patients with Parkinson's Disease (PD) who have swallowing difficulties and drooling problems. This study focuses on improving the device's battery life and size, assessing usability with patient feedback, and testing its ability to detect and encourage swallowing in PD patients. The aim is to provide a digital therapeutic platform that can support swallowing function in this population. The wearable device, called the Aria sensor, is a patch that monitors physiological signals continuously and provides vibratory haptic cues to increase how often participants swallow. Participants will use the sensor for three weeks, with the device actively providing haptic cues only during the second week. This single-arm study tracks how the sensor performs in real-life conditions without randomization or blinding. Participants will be involved for three weeks, during which researchers will measure swallow frequency changes, participant adherence to using the haptic cues, and changes in clinical scales related to drooling and swallowing. Assessments include comparing sensor data to a gold standard and evaluating symptom severity before and after the intervention. The study also includes focus groups to gather patient feedback on usability, and safety monitoring is conducted throughout the study period.

Researchers are investigating a new way to predict severe oropharyngeal mucositis caused by radiation therapy in patients with nasopharyngeal carcinoma (NPC), a cancer common in southern China. The study focuses on a mucosal contouring method based on swallowing-induced breakthrough pain, which showed better prediction results than previous methods. This prospective, multicenter, observational study aims to further evaluate the effectiveness of this new predictive approach. The study observes patients with NPC who are undergoing radical radiotherapy or chemoradiotherapy. Researchers will use the new mucosal delineation method to assess radiation-induced oropharyngeal mucositis by monitoring swallowing-induced breakthrough pain. This method aims to identify patients at high risk for severe mucositis to help guide timely interventions, although no specific treatments are provided within the study. Participants will be monitored throughout the study period, which can last up to three years. Researchers will collect continuous records of mucositis severity and self-reported pain during swallowing. The study measures the accuracy of the predictive model using various statistical tools like AUC, sensitivity, and specificity. Safety and other important predictors of mucositis will also be evaluated, with no additional treatments or interventions required for participants.

Swallowing disorders are common in intensive care unit (ICU) patients, especially those with tracheostomies that can cause changes affecting swallowing. These disorders are linked to serious problems like respiratory issues, poor nutrition, and even death. Current clinical exams lack precision, while existing tests like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) are invasive, resource-heavy, and hard to access. Researchers are exploring ultrasound imaging as a non-invasive and precise method to assess swallowing disorders in difficult-to-wean tracheostomised ICU patients. This observational study will enroll 119 difficult-to-wean tracheostomised patients over nineteen months at multiple hospitals. Each patient will undergo FEES and ultrasound evaluations within a two-hour window. Ultrasound will assess movements and structures including the tongue, larynx, and suprahyoid muscles. The ultrasonographer will be blinded to other assessments. The goal is to develop a diagnostic ultrasound model using selected variables, which will be transformed into an easy-to-use scoring system to predict swallowing disorders. Participants will be assessed through clinical data collection and swallowing tests. Ultrasound exams will measure features like tongue thickness and muscle contractions, while FEES will evaluate swallowing function and residue severity. Reliability tests will be done with multiple examiners. Researchers will analyze data statistically to create and validate the ultrasound score’s accuracy and reliability. The study aims to improve early detection and management of swallowing disorders non-invasively, over the course of the study period ending in April 2026.

Researchers are evaluating the effectiveness of low volume Transanal Irrigation (TAI) using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome (LARS). This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups: one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy; and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires (EORTC QLQ-C30 and QLQ-CR29), incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.

Researchers are studying a new mucosal contouring method to predict radiation-induced oropharyngeal mucositis in patients with nasopharyngeal carcinoma (NPC). This condition, which causes swallowing-induced breakthrough pain, greatly affects patients' quality of life during radiotherapy. Previous prediction models using oral cavity or mucosa surface contouring were not satisfactory, so this study aims to further evaluate a method based on mucosal areas linked to breakthrough pain in a real-world, multicenter observational setting. This observational study will follow patients with locally advanced NPC undergoing radical radiotherapy or chemoradiotherapy. The study focuses on assessing how well the mucosal delineation method predicts the occurrence and severity of oropharyngeal mucositis by tracking swallowing-induced breakthrough pain. There are no investigational treatments involved; instead, patients are observed and data is collected during their standard care. Participants will have their oral or oropharyngeal mucositis severity and swallowing pain recorded continuously throughout their treatment. Researchers will analyze the predictive model's performance by measuring accuracy, sensitivity, specificity, and other statistical values over up to three years. The study will help improve risk assessment and early intervention for mucositis in NPC patients, with all data collected during their regular clinical visits.

Researchers are studying nutritional support strategies for critically ill patients with impaired gastrointestinal function, focusing on how to best achieve energy and protein intake goals. The study investigates the use of enteral nutrition alone versus a combination of enteral nutrition and supplemental parenteral nutrition (SPN) in patients who have impaired gastric emptying and reduced intestinal absorption. This research addresses the challenge of feeding intolerance and malnutrition in intensive care patients and explores muscle mass and function as important factors in nutrition efficacy. The study randomly assigns patients with diagnosed gastrointestinal dysfunction to one of two groups: one receiving gradual increases in enteral nutrition based on tolerance, and the other receiving a mix of enteral trophic feeding plus SPN to meet nutritional targets. Nutritional needs are monitored daily by indirect calorimetry, and gastrointestinal function is assessed with ultrasound gastric residual volume and a paracetamol absorption test. The SPN group aims to reach 80% of nutritional goals by day five, while the enteral nutrition group aims for full caloric intake as tolerated. Participants are monitored through various evaluations including muscle thickness via ultrasound, lean body mass by bioelectrical impedance analysis, and muscle strength with a handgrip dynamometer at admission and on days 10 and 15. The study measures daily calorie and protein intake adequacy, metabolic markers, and clinical outcomes such as mortality up to 28 days. Nutritional status, muscle function, and energy utilization are carefully assessed throughout the study to understand the impact of the tailored feeding protocols.

Researchers are evaluating a new approach to treating patients with squamous cell carcinoma of the oropharynx who have larger primary tumors (stage T3-T4). This phase II randomized trial compares the current standard chemoradiation treatment with a new method that adapts radiotherapy based on MRI scans taken mid-treatment. The goal is to see if adjusting radiation therapy according to tumor shrinkage seen on MRI can reduce swallowing difficulties measured six months after treatment. Participants will be randomly assigned to one of two groups. The standard care group receives radiotherapy planned at the start of treatment, with adjustments only if major anatomical changes occur. The experimental group receives systematic radiation plan changes guided by mid-treatment MRI scans to target the shrinking tumor. Both groups may also receive chemotherapy as part of their treatment. This study uses advanced MR-Linac technology to enable detailed imaging during therapy. During the study, patients will undergo assessments including patient-reported swallowing function measured six months after treatment using the MD Anderson Dysphagia Inventory. Researchers will also monitor acute and late side effects for up to five years after chemoradiation. The trial includes safety monitoring and statistical review of interim data to ensure appropriate sample size. Participation involves regular clinical visits, imaging, and questionnaires to track treatment effects and quality of life.

Researchers are evaluating advanced therapeutic endoscopy procedures to provide minimally invasive treatment options for gastrointestinal (GI) diseases such as Zenker Diverticulum, colon polyps, and colorectal cancer. This registry-based observational study at the Centre Hospitalier de l'Université de Montréal aims to improve the quality of advanced endotherapeutic practices by collecting and analyzing data to identify both low-quality and high-quality procedures. The study includes various advanced endoscopic procedures such as Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), polypectomy quality assessment for colorectal adenomas/polyps, Radio Frequency Ablation (RFA), Argon Plasma Ablation (APC), and Per Oral Endoscopic Myotomy (POEM). These procedures are recorded prospectively in a protected electronic registry. Each technique involves specific methods, including mucosal resection, submucosal dissection, thermal ablation, and endoscopic myotomy under general anesthesia with expert operators and specialized equipment. Participants undergo these advanced endotherapeutic procedures with data collected on outcomes such as complication rates, completeness of tissue resection, bleeding, perforation, and recurrence over 6 to 18 months. The study monitors technical skills of endoscopists and assesses quality of life after treatment. Safety is tracked through severe complication rates within 14 days post-procedure. This long-term follow-up supports efforts to enhance therapeutic endoscopy quality and patient care.

This research aims to evaluate the safety and effectiveness of the BougieCap device for stretching narrow areas in the esophagus (food pipe) in children. The study compares the BougieCap with traditional dilation methods such as Savary-Bougie or balloon dilation. The goal is to determine if the BougieCap works better, is easier to use, and causes fewer problems or discomfort for children with benign esophageal strictures. Participants are randomly assigned to one of two groups: one group using the BougieCap attached to an endoscope that allows direct visual and tactile control during dilation, and the other group receiving standard treatment with either Savary-Bougie dilation or balloon dilation under endoscopic or radiological control. These treatments involve gradually widening the narrow esophageal areas using different techniques and sizes of dilators or balloons. During the study, participants will answer questions about their symptoms before treatment, 24 hours after, and 14 days later, either during regular hospital visits or over the phone. Researchers will monitor the success of the dilation immediately after the procedure and assess any adverse events, such as bleeding or infections. The study does not add extra risks or burdens for participants and continues until December 2026.

Taste problems and dry mouth (xerostomia) are common symptoms in patients with advanced cancer. These symptoms can reduce the pleasure of eating and drinking, lower dietary intake, cause low mood, and reduce quality of life. This research aims to explore how dry mouth and taste problems are related in this patient group to better understand their impact and causes. This observational study will assess taste disturbances and dry mouth in patients with advanced cancer using questionnaires like the Oral Symptom Assessment Scale and the Taste Questionnaire in Palliative Care, along with an objective taste test called the Waterless Empirical Taste Test. The study will characterize different types of taste disturbances and look at how these affect dietary intake and quality of life. It will also identify other oral symptoms that may be linked to taste problems and dry mouth. Participants will be asked to complete questionnaires and undergo taste testing to measure their symptoms and the effects on their diet and quality of life. The study will collect data until December 2025. Researchers will monitor the prevalence and features of taste problems and dry mouth, aiming to improve understanding for better screening and management. The total study duration for each participant may vary based on their involvement and assessments.