Clinical Research Directory

Effect of Visual Biofeedback-Assisted Oropharyngeal Exercises in Post-Stroke Dysphagia

Post-stroke dysphagia is a common complication that negatively affects nutritional status, quality of life, and morbidity. Conventional swallowing rehabilitation, including oropharyngeal exercises and neuromuscular electrical stimulation (NMES), is widely used to improve swallowing function. This randomized controlled clinical study aims to investigate the effectiveness of visual biofeedback-assisted oropharyngeal exercises combined with NMES in patients with post-stroke dysphagia. Participants will be randomly assigned to either a visual biofeedback-assisted exercise group or a conventional exercise group, with both groups receiving NMES. Treatment will be administered five days per week for four weeks. Changes in swallowing function, suprahyoid muscle activity assessed by surface electromyography, and muscle stiffness evaluated by shear wave elastography will be analyzed to determine the effectiveness of the intervention.

MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL)

The goal of this study is to find out how muscle wasting in the mouth and throat affects swallowing (dysphagia) in adults who are critically ill and being treated in intensive care units. The main aims of this research study are to understand: how much and how quickly the oral and suprahyoid muscles waste in critically ill participants, and whether muscle wasting causes problems with swallowing. The investigators will compare critically ill participants with non-critically ill participants to determine if muscle wasting is linked to swallowing problems. In this study, participants will have the size and strength of their mouth and throat muscles measured at four different times during their critical care admission and hospital stay. Tests will also be performed to check how well and how safely participants can swallow. Tongue strength will be measured, and participants will answer questions about their experience with swallowing and eating using patient-reported outcome measures. This study may help identify better ways to diagnose and treat swallowing problems in people who are critically ill, to support safe eating and drinking and promote faster recovery.

The Effect of Swallowing Exercise and Maneuver Program For Older Adults With Dysphagia in Nursing Home

This clinical trial aimed to evaluate the effectiveness of a structured swallowing exercise and maneuver program for older adults with dysphagia living in a nursing home. Dysphagia, or difficulty in swallowing, is common in elderly populations and may lead to malnutrition, dehydration, and aspiration pneumonia. In this study, 72 participants aged 60 years and older were randomly assigned to either an intervention group or a control group. The intervention group received a combined swallowing exercise and maneuver program-including Masako Maneuver, Chin Tuck Against Resistance, Supraglottic Swallow, and Super-Supraglottic Swallow-performed three times daily before meals over a six-week period. The control group received standard care, including upright sitting posture during meals. Swallowing ability was measured using the EAT-10 questionnaire. The intervention group showed significant improvement in swallowing scores, while no meaningful changes were observed in the control group. This study suggests that nurse-led swallowing exercises can be a safe, simple, and effective strategy to improve swallowing function and quality of life in older adults living in long-term care settings.

Tongue Pressure in Middle-Aged and Elderly Individuals With Chronic Cervical Pain

The goal of the cross-sectional study is to explore the impact of neck pain on tongue pressure in the middle-aged and elderly population and analyze the effects of different cranio-cervical positioning on tongue pressure performance. The main questions it aims to answer are: 1. Do middle-aged and elderly individuals with chronic cervical pain exhibit reduced maximal tongue pressure compared to those without cervical pain? 2. What are the effects of different cranio-cervical positioning on tongue pressure performance? Participants will complete all the assessments on the day of testing.

Modelling of Pharyngeal Laryngeal Effectiveness

The purpose of this study is to collect the signals of pharyngeal laryngeal activity through five non-invasive sensors (microphone, accelerometer, surface electromyography (EMG), nasal cannula and oximeter) in order to identify indicators of functional efficiency of swallowing, protection of the lower airways and phonation. 440 patients (subjects with swallowing disorders), spread over 4 centers and 80 healthy subjects spread over 2 centers will be recruited for the study in an interventional research study involving the prospective, multicentric and longitudinal. Pharyngolaryngeal effectiveness will be measured from 6 indicators identified by examinations or reference tests grouped into 3 functions: * swallowing: pharyngeal transport capacity (Yale Residue) and Penetration Aspiration Scale (PAS) rated by videofluoroscopy of swallowing (VFS) or flexible endoscopic evaluation of swallowing (FEES); * airway protection: cough trigger (citric acid test) and cough power (peak expiratory flow); * phonation: vocal efficiency (maximum phonation time) and velar efficiency (nasal scores). The signals obtained from the 5 sensors will be annotated. Stochastic modelling based on hidden Markov models will be used initially and followed by the implementation of deep neural networks to model indicators. For the complication's prediction algorithm, deep neural networks will also be used to evaluate signal-based methods. The expected benefits are to obtain automated recognition of pharyngeal-laryngeal effectiveness to diagnose swallowing disorders using objective and quantifiable indicators, non-invasive devices, to assess the severity of these disorders and to identify the risk of complications.

Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2)

Radiotherapy for head and neck cancers (H\&NC) heightens the risk of swallowing disorders (SD), impacting nutrition, quality of life, and overall health, leading to increased hospitalization and mortality. Dietary plans hinge on patients' nutritional status, swallowing ability, and prognosis. Early interventions are crucial, emphasizing the need for precise assessments guiding prognosis, specifying structures for intervention, and facilitating targeted rehabilitation. Clinical examinations lack precision, while existing complementary methods like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing are invasive, irradiating, resource-intensive, and challenging to access, with uncertain prognostic values. Ultrasound imaging emerges as a non-invasive alternative, offering morphological and dynamic evaluation of swallowing-related structures. It enables qualitative and quantitative analyses, improving precision in targeting structures for rehabilitation. Researchers propose an ultrasound predictive model to anticipate SD risk during H\&NC radiotherapy, assessing its reliability and accuracy. Over eighteen months, 124 outpatients beginning H\&NC radiotherapy at Forcilles's Hospital will undergo weekly clinical and water-swallow tests by a speech language therapist, with videofluoroscopy when SD is suspected. Ultrasound evaluations pre-treatment and at seven and fourteen days will be conducted by blinded ultrasonographers. Cox models will test ultrasound measurement thresholds for SD prediction, estimating sensitivity, specificity, and prediction values. A global ultrasound predictive model will be developed via logistic multivariable regression. The study aims to establish an association between ultrasound markers and SD, improving early detection for tailored management. This non-invasive alternative to videofluoroscopy offers potential for enhancing patient outcomes in H\&NC radiotherapy.

Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures. The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.