Achalasia

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 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.

Achalasia is a rare condition caused by the loss of nerve cells in the lower esophagus, leading to swallowing difficulties. Researchers are studying the occurrence of gastroesophageal reflux disease (GERD) and esophagitis in patients who have undergone peroral endoscopic myotomy (POEM), a minimally invasive treatment designed to address achalasia. This observational study aims to understand how often reflux and silent GERD appear after POEM and to identify factors linked to these outcomes. Participants in this study are achalasia patients who have had the POEM procedure. They will undergo various assessments before and after treatment, including scoring of symptoms, questionnaires about reflux symptoms, high-resolution esophageal pressure tests, endoscopic examinations, and pH monitoring to measure acid exposure. No new treatments are given; the study focuses on monitoring and evaluating the effects after POEM. During the study, participants will have follow-up evaluations over a period of up to 36 months to track the presence of reflux and esophagitis. Researchers will collect data on patient symptoms, test results, and procedural details to analyze risk factors associated with post-POEM GERD. The main outcome measured is the prevalence of gastroesophageal reflux after the procedure. The study is sponsored by the Maria Sklodowska-Curie National Research Institute of Oncology and does not involve healthy volunteers.

Researchers are evaluating the combination of Anlotinib Hydrochloride Capsules and TQB2450 Injection as a postoperative adjuvant therapy for patients with esophageal squamous cell carcinoma (ESCC). This Phase II, open-label, single-arm study aims to assess the efficacy and safety of this combination treatment, focusing primarily on disease-free survival (DFS). The study also looks at one- and three-year DFS and overall survival rates, along with safety outcomes classified by adverse event severity. Participants will receive treatment in 21-day cycles, taking Anlotinib orally at 12 mg daily for the first 14 days, along with a single intravenous dose of 1200 mg TQB2450 on day one of each cycle. If participants experience side effects from Anlotinib, the dose may be reduced to 10 mg or 8 mg. The study treatment continues as determined by the researchers. During the study, participants will be closely monitored through laboratory tests and imaging to detect any cancer recurrence or progression. Researchers will track disease-free survival from the start of treatment up to 96 months, along with overall survival rates at one and three years. Safety will be evaluated by recording and categorizing adverse events. Participants are expected to follow up regularly and comply with study procedures throughout the treatment and observation period.

Researchers are evaluating whether a behavioral health program can improve swallowing and voice outcomes in patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgery. This prospective study enrolls patients having primary ACDF surgery and aims to determine if the program helps prevent swallowing and voice difficulties six weeks after surgery. The research is conducted at NYU Langone and focuses on dysphagia, which affects swallowing ability. Participants will receive a behavioral intervention program including hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercises for seven weeks total. This begins one week before surgery and continues for six weeks afterward. Weekly 45-minute sessions with a speech-language pathologist start about one week post-surgery and last for six weeks. The study compares these patients to historical controls who had ACDF surgery but did not receive the intervention. During the study, participants will undergo swallowing assessments using videofluoroscopy before surgery and six weeks after. Acoustic voice samples and patient-reported measures for swallowing and voice will also be collected at these times. Researchers will track adherence to hydration goals via a daily log. The main outcomes measured include changes in swallowing function and voice quality from baseline to six weeks post-operation. The total study duration for each participant is seven weeks.

Researchers are evaluating a new artificial intelligence (AI) tool designed to assist during third space endoscopic procedures, such as Endoscopic Submucosal Dissection (ESD) and Peroral Endoscopic Myotomy (POEM). These procedures treat gastrointestinal tumors and motility disorders but carry risks of bleeding and perforation if blood vessels under the mucosa are not properly identified and managed. This study aims to see if the AI can help endoscopists detect and outline blood vessels more accurately and quickly during live procedures, building on previous retrospective studies. The study uses an AI system integrated into the Olympus EVIS X1 endoscopy equipment to provide real-time visual overlays that highlight submucosal blood vessels. Participants will be randomly assigned to two groups: one where the endoscopist sees the AI-generated vessel segmentation mask during the procedure, and another where the endoscopist performs the procedure without AI assistance. The performance of vessel detection and timing will be recorded and compared with expert reviews after the procedure. Participants diagnosed with Achalasia Cardia or tumors will take part in this prospective trial. Researchers will evaluate how well the AI improves the Vessel Detection Rate (VDR) and Vessel Detection Time (VDT) during the first three months. Safety monitoring will focus on procedural outcomes related to vessel identification. The total participation time and detailed follow-up procedures are aligned with the study design to ensure comprehensive evaluation of the AI tool during these complex endoscopic procedures.

Researchers are studying swallowing problems that may develop in very sick patients who need a machine to help them breathe. These patients require a tube placed in their throat, called an endotracheal tube, to allow the ventilator to push air into their lungs. After removing this tube, a condition called post-extubation dysphagia (PED) can occur, causing difficulty swallowing and risk of food or liquids entering the lungs, which may lead to lung problems. The study aims to better understand how often PED occurs, why it happens, and how to best detect it. Participants will receive several tests to evaluate swallowing function after extubation. These include a tracheal ultrasound within 72 hours before tube removal, demographic and clinical data collection, three different swallowing screening tests within 24 hours after extubation, and a fiberoptic endoscopic examination of swallowing (FEES). The FEES exam uses a small flexible camera passed through the nose to view swallowing and assess for dysphagia. During the study, researchers will monitor swallowing ability and the presence of aspiration from extubation day 1 through hospital discharge, expected within 28 days. They will also assess other outcomes like laryngeal swelling and duration of mechanical ventilation. Participants may have videos of their swallowing recorded for evaluation by specialists. The total involvement includes these assessments and data collection during the hospital stay after extubation.

This research aims to compare the effectiveness and safety of two different peroral endoscopic myotomy (POEM) techniques in treating patients with achalasia types I and II. The study focuses on conventional myotomy, which involves cutting only the inner circular muscle layer, and a modified approach called full-thickness myotomy, which includes cutting the full thickness of the muscle bundle. The goal is to determine which method better improves symptoms and reduces complications for achalasia patients. Participants will receive one of two procedures: conventional myotomy or full-thickness myotomy. Both procedures start with a mucosal incision and creation of a submucosal tunnel near the gastroesophageal junction. The conventional method cuts only the circular muscle, while the full-thickness method additionally cuts the full muscle layer near the junction. After myotomy, the mucosal incision is closed with clips. The study compares these techniques by randomly assigning participants to one of the two groups. During the study, participants will be closely monitored before, during, and after the procedure. Researchers will measure therapeutic success at six months following treatment, along with procedure time, pressure changes in the esophagus, esophagogram results, complication rates, severity of esophagitis, and pain after POEM. Other assessments include endoscopic scoring and hospitalization duration. These evaluations will help determine the safety and benefits of each myotomy approach over a six-month period.

Researchers are evaluating whether biofeedback treatment is more effective than standard verbal feedback training in helping people recover from dysphagia after a stroke. This multicenter randomized controlled study will enroll 100 patients who have had a stroke and experience swallowing difficulties. The goal is to compare the recovery of swallowing function between those receiving biofeedback and those receiving conventional therapy without visual feedback. Participants will undergo 20 sessions over 4 weeks, attending five one-hour sessions each week. In the biofeedback group, sensors will be placed on the mylohyoid muscle to provide real-time visual feedback on muscle activity during swallowing exercises. The control group will perform the same swallowing maneuvers but will receive only verbal feedback from a speech therapist. Both groups will use effortful swallow techniques, timing and coordination tasks, and the Masako maneuver during training. Before starting treatment, and at two follow-up points—after 4 weeks of therapy and again two months later—patients will have clinical and instrumental evaluations including fibroendoscopy and several swallowing function scales. Researchers will measure swallowing efficacy, penetration/aspiration, pharyngeal residues, and quality of life related to swallowing. Data will be analyzed statistically to assess treatment effects and safety throughout the study duration.

Researchers are studying the effects of a structured four-week expiratory muscle strength training (EMST4) program on swallowing function in patients with Parkinson's disease who have difficulty swallowing (dysphagia). This non-randomized intervention aims to assess how EMST influences the biomechanics of swallowing using advanced techniques to measure neuromuscular changes. Participants will undergo daily EMST sessions consisting of 5 sets of 5 breaths, carried out 5 days a week for one month. The study uses devices to provide this training and evaluates swallowing function through fiberoptic endoscopic evaluation of swallowing (FEES) combined with pharyngeal high-resolution manometry (HRM) to gather detailed biomechanical data. Throughout the study, participants will be assessed at one month and three months to measure changes in swallowing biomechanics, including the pharyngeal contractile integral (PhcI), and to evaluate swallowing safety and efficiency using DIGEST-FEES scoring. The research team will monitor participants' progress with these objective measures to understand the impact of the EMST program on swallowing function over time.