Deglutition Disorders

12

Review clinical trials related to Deglutition Disorders. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

AI-Enabled Mobile App for Safe Eating in Older Adults With Dysphagia

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 a smartphone application powered by artificial intelligence (AI) 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, and the app then estimates the texture level and provides guidance to help ensure it is safe to swallow. It also gives simple prompts to double-check food texture when needed. 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 16 weeks. Participants will continue their daily eating routines at home. The main question this study is trying to answer is: Does using the AI-enabled mobile app improve how often people eat foods that match their recommended safe texture level compared with usual care alone? The study will also examine whether the app helps reduce swallowing-related problems (such as choking), improves quality of life, and supports better overall eating ability. In addition, the study will evaluate how easy the app is to use and whether it places any burden on users. Hypothesis: The researchers hypothesize that participants who use the AI-enabled app, in addition to usual care, will more consistently follow recommended food texture guidelines and experience safer eating compared with those who receive usual care alone.

Participants needed: 332
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: KAM Chi Shan AnnaUpdated: Jun 17, 2026Locations: 1
Eligibility criteria

Adults aged 60 years or above [+6]

Exclusive dependence on non-oral feeding (e.g., tube feeding) [+5]

Status: Not yet recruiting

Silent Aspiration Following Extubation in the ICU

Post-extubation dysphagia is common in critically ill patients and may lead to silent aspiration, which often remains undetected because patients do not exhibit overt clinical signs such as coughing or choking. Current bedside nursing swallow screening may fail to identify silent aspiration in patients recovering from prolonged mechanical ventilation. The goal of this observational study is to learn about the incidence, risk factors, and clinical outcomes of silent aspiration in critically ill adult patients who require prolonged mechanical ventilation and are extubated in the ICU. The main questions it aims to answer are: * How often does silent aspiration occur in ICU patients intubated for 5 days or longer after extubation? * Can silent aspiration be present despite passing the routine bedside nursing swallow screen? * What clinical factors are associated with silent aspiration? * Is silent aspiration associated with worse clinical outcomes such as aspiration pneumonia, reintubation, prolonged ICU stay, ventilator-free days, or mortality? Participants who have been mechanically ventilated for 5 days or more will undergo routine bedside swallow screening followed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES), considered the gold-standard diagnostic tool for detecting silent aspiration, within 72 hours after extubation. Researchers will compare bedside nursing swallow screening results with FEES findings to evaluate the diagnostic accuracy of bedside screening in detecting silent aspiration. Clinical data, swallowing assessment findings, and patient outcomes will also be collected and analyzed.

Participants needed: 274
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Cleveland Clinic Abu DhabiUpdated: Jun 9, 2026Locations: 1
Eligibility criteria

Adult ICU patients requiring invasive mechanical ventilation for 5 days or longe... [+4]

Presence of tracheostomy [+4]

Status: Recruiting

Effectiveness of Best Care Practices in Acute Stroke in Conventional Hospitalization (BEST CARE ICTUS_HC)

The goal of this clinical trial is to evaluate whether a multicomponent nurse-led intervention (BEST CARE ICTUS\_HC) can reduce stroke-related complications and improve recovery in adults (18 years and older) hospitalized with an acute ischemic or hemorrhagic stroke in hospitals without specialized Stroke Units. The main questions it aims to answer are: 1. Does the implementation of the program increase the early and correct detection of swallowing difficulties (dysphagia) to prevent pneumonia? 2. Does the program reduce the severity of attention problems (hemineglect) and improve the patients' quality of life up to 6 months after discharge? Researchers will compare patients receiving the BEST CARE ICTUS\_HC program to patients receiving usual hospital care to see if this new approach improves patient safety and long-term functional recovery. Participants will: * Receive either the usual hospital care for stroke or the BEST CARE ICTUS\_HC nursing program, depending on the study phase of the hospital. * Be screened for swallowing problems using a standardized test before receiving any food or drink. * Be cared for in an adapted environment (FLECHA Project) that uses visual signs and room organization to help with orientation and safety. * Have their temperature, blood sugar, and blood pressure monitored under a strict specialized protocol. * Be contacted by phone 30 days and 6 months after leaving the hospital to answer questions about their health and quality of life.

Participants needed: 700
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of MalagaUpdated: Jun 4, 2026Locations: 4
Eligibility criteria

Patients aged 18 years or older. [+2]

Patients admitted for a cause other than stroke who develop a stroke during thei... [+4]

Status: Recruiting

Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia

The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia.

Participants needed: 30
Trial details
Age: 19+Biological sex: AllType: InterventionalSponsor: NEUROPHETUpdated: Apr 9, 2026Locations: 1
Eligibility criteria

men and women >19 years old [+4]

patients with recurrent stoke, traumatic brain injury, spine cord injury, and de... [+11]

Status: Not yet recruiting

Effects of Different-Frequency Electroacupuncture on Suprahyoid Muscles in Post-Stroke Dysphagia: Efficacy and Neural Networks

This randomized controlled study in patients with post-stroke dysphagia aims to determine the optimal stimulation frequency of electroacupuncture of the suprahyoid muscles and to elucidate the underlying neural mechanisms. Participants will be assigned to low-frequency (2 Hz), medium-frequency (50 Hz), or high-frequency (100 Hz) electroacupuncture groups. Therapeutic efficacy will be assessed using the Kubota water-drinking test, videofluoroscopic swallowing study (VFSS), and ultrasonography to identify the optimal frequency. In parallel, diffusion tensor imaging (DTI) will be used to evaluate changes in fiber connectivity between swallowing-related cortical regions (bilateral precentral gyrus, insula, supramarginal gyrus, and frontal lobe) and the medullary nucleus tractus solitarius, thereby exploring neural network remodeling and providing mechanistic evidence to inform clinical practice.

Participants needed: 90
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Kaili ChenUpdated: Mar 27, 2026Locations: 1
Eligibility criteria

Diagnosis: Patients diagnosed with cerebral infarction confirmed by CT or MRI. [+4]

Dysphagia Etiology: Patients with dysphagia caused by etiologies other than cere... [+6]

Status: Recruiting

Effectiveness of an mHealth Intervention, Based on Rehabilitation and a Personalised Nutrition Plan, in the Recovery and Improvement of Dysphagia in Patients Diagnosed With Stroke

The goal of this clinical trial is to evaluate the efficacy of an mHealth intervention as a complement to usual clinical practice for the improvement and recovery of dysphagia in patients who have suffered a stroke. The main question it aims to answer is: \- Does the mHealth intervention improve the recovery of dysphagia in post-stroke patients compared to usual care alone? Researchers will compare patients receiving the mHealth intervention plus usual care to see if the combined approach leads to better dysphagia outcomes, reduced negative consequences (e.g., malnutrition, pneumonia), and improved quality of life compared to usual care alone. Participants will be recruited and: * Receive a diagnosis and usual care for post-stroke dysphagia. * Be assigned to either the mHealth intervention group (using a smartphone/tablet app for information and follow-up) or the control group (usual care only). * Be followed up to assess dysphagia recovery, reduction in negative outcomes (like aspiration pneumonia, dehydration), and changes in quality of life.

Participants needed: 74
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of CadizUpdated: Feb 3, 2026Locations: 1
Eligibility criteria

Subjects aged 18 years or older. [+1]

Hospitalized patients presenting any type of visual barrier. [+6]

Status: Recruiting

Occupational Therapy Rehabilitation for Frail Elders with Dysphagia

The goal of this proof-of-concept study is to assess the potential of a newly developed intervention with combined skill- and strength-based principles for maximizing swallowing-related outcomes and prevent further weakening of the swallowing muscles in older people with dysphagia (difficulty swallowing). The main questions to be answered are: 1. Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia? 2. Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia? 3. Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia? 4. Is there an association between perceived autonomy support and intervention engagement when older individuals with dysphagia receive the intervention during hospitalization and continued in community-based rehabilitation after discharge? Participants will be asked to perform goal-directed and task-specific swallowing exercises in eating and drinking activities where the intensity variables include advancing steps of an altered bolus volume and consistency according to a 17-level task hierarchy, which are introduced according to predetermined progression rules, as well as increases in swallowing repetitions. The dosage is 2-3 individual, face-to-face therapy sessions per week for up to a maximum of eight weeks. A therapy session lasts up to 45 min. In between therapy sessions, participants integrate the achieved level from therapy into their daily meals as self-training.

Participants needed: 30
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Hvidovre University HospitalUpdated: Mar 14, 2025Locations: 1
Eligibility criteria

A score of 5-18 on the Gugging Swallowing Screen. [+3]

Esophageal dysphagia. [+5]

Status: Recruiting

Automatic Voice Analysis for Dysphagia Screening in Neurological Patients

The proposed study suggests using automatic voice analysis and machine learning algorithms to develop a dysphagia screening tool for neurological patients. The research involves patients with Parkinson's disease, stroke, and amyotrophic lateral sclerosis, both with and without dysphagia, along with healthy individuals. Participants perform various vocal tasks during a single recording session. Voice signals are analysed and used as input for machine learning classification algorithms. The significance of this study is that oropharyngeal dysphagia, a condition involving swallowing difficulties in the transit of food or liquids from the mouth to the esophagus, generates malnutrition, dehydration, and pneumonia, significantly contributing to management costs and hospitalization durations. Currently, there is a lack of rapid and effective dysphagia screening methods for healthcare personnel, with only expensive invasive tests and clinical scales in use.

Participants needed: 400
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Istituti Clinici Scientifici Maugeri SpAUpdated: Feb 20, 2025Locations: 2
Eligibility criteria

Patients with a diagnosis of stroke, Parkinson's disease, or amyotrophic lateral... [+1]

Cognitive impairment that do not allow participants to understand the requested... [+1]

Status: Recruiting

EMST in Patients Undergoing CRT for HNCA

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on maintenance of safe and efficient oropharyngeal swallow function in persons with cancer of the head and neck (HNCA) undergoing treatment with radiation therapy or chemoradiotherapy (RT/CRT).

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Wisconsin, MilwaukeeUpdated: Dec 4, 2024Locations: 2
Eligibility criteria

New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx; [+3]

Primary surgery to the head and neck (neck dissection is permitted); [+5]

Status: Recruiting

A New Ultrasound Score for Swallowing Disorders Diagnosis in Difficult-to-wean Tracheostomised Patients

Swallowing Disorders (SD) is commonly observed in intensive care unit (ICU) patients. Disruption to the upper airway by way of a tracheostomy may lead to physiological and/or biomechanical changes to the swallow, thereby increasing dysphagia risk. SD is independently associated with adverse outcomes including respiratory complications, nutritional compromise, and even death. Experts recommend a systematic bedside screening. Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening positive patients. However, the clinical examination lacks precision. Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources and are difficult to access. No current consensus exists on how to best approach to evaluate ICU patients at risk. In this context, US imaging has garnered increased interest for assessing swallowing disorders. Recognised for its non-invasive nature and its ability to overcome conventional constraints, this approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance the precision in targeting structures for rehabilitation. The researchers intend to create an ultrasound diagnostic model for difficult-to-wean trahceostomised patients. Additionally, they aim to evaluate the reliability and accuracy of this model. During an nineteen-months period, we will enrolled one hundred and nineteen difficult-to-wean tracheostomised patients at Forcilles's Hospital, Universitary Hospital of Dijon, Béthune Hospital and Bourgon Jallieu Hospital. All patients will have a FEES evaluation. The ultrasonographer will be blinded to the patient's status and prior clinical or imaging assessments. Ultrasound assessment will focus on evaluating the movements or morphology of structures such as the tongue, laryngeal movement, or suprahyoid muscles. A global ultrasound diagnostic model will be developed after selecting variables in logistic multivariable regression. Its sensitivity and specificity and prediction value will be estimated. The constructed model will be transformed in an easy-to-use scoring system. The study anticipates establishing an association between ultrasound markers and swallowing disorders, aiming to enhance early detection for tailored management strategies, providing a non-invasive alternative to videofluoroscopy or FEES.

Participants needed: 114
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Hopital ForcillesUpdated: Oct 8, 2024Locations: 4
Eligibility criteria

Patients admitted to ICU and tracheostomised for difficult-to-wean reasons ; [+5]

Patient with total laryngectomy; [+9]

Status: Not yet recruiting

Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia

Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated \>48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with \>48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects \>18 years old, admitted to an intensive care unit (ICU), with \>48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics

Participants needed: 150
Trial details
Age: 18-65Biological sex: AllType: ObservationalSponsor: Universidad Europea de MadridUpdated: Jul 1, 2024Duration: 1 Year
Eligibility criteria

• Subjects >18 years old. [+1]

• Congenital or acquired conditions of the Central Nervous System (CNS) such as... [+8]

Status: Not yet recruiting

Design and Development of a Functional Plant-based Beverage Formulated According to the Main Nutritional Guides for Early Elderly Requirements to Improve Nutritional Status and Immunity for the Early Elderly People to Get Well-healthy Ageing

Populations around the world are aging and this demographic transition will impact almost every aspect of society. Furthermore, the COVID-19 pandemic has highlighted the seriousness of gaps in policies, systems and services. According to the World Health Organization (WHO) plan for 2021-2030, a decade of concerted global action on healthy ageing is urgently needed to ensure that older people can realize their potential in dignity and equality in nutritional requirements. An effective way to address the inherent demographic change, which translates into the health status of older people, is through the maintenance of adequate nutritional status. Public health services require new funding to address this problem, but if we bring new strategies to health policies, by improving nutrition, we could impact the reduction of costs at the level of medical care in the ageing population. In older people, according to the latest guidelines on nutritional requirements in geriatrics from the Spanish Nutrition Foundation (FEN), the British Nutrition Foundation and The European Society for Clinical Nutrition and Metabolism (ESPEN), multinutrient strategies instead of mononutrient strategies, are gaining importance due to relevant scientific evidence based on controlled and randomized clinical trials. Therefore, following the nutritional requirements in healthy ageing, an important aspect is to strengthen immunity in this population. Consequently, the food industry is booming in the development of new functional alternatives, such as plant-based beverages, which are well positioned in the market and can offer healthy functional beverage options to people of early elderly age (60 to 75 years) as a target population due to the ease with which they are ingested. Therefore, investments in small and medium-sized companies to encourage the incorporation of trained doctoral personnel and add innovation value to this type of product are essential for resilience. Therefore, the present proposal hypothesizes that, following the nutritional needs for healthy ageing, a multinutrient-optimized beverage as a functional food can improve immunity and reduce inflammation and oxidation in women and men in the elderly population.

Participants needed: 80
Trial details
Age: 60-75Biological sex: AllType: ObservationalSponsor: University Rovira i VirgiliUpdated: Jun 6, 2024
Eligibility criteria

Type 2 diabetes [+6]