[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hopital Forcilles\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100633632","effectiveness-of-transcutaneous-nmes-as-an-adjunct-for-swallowing-disorders-in-tracheotomized-patients-100633632",false,"NCT07529210","Effectiveness of Transcutaneous NMES as an Adjunct for Swallowing Disorders in Tracheotomized Patients","Evaluation of the Effectiveness of Transcutaneous Neuromuscular Electrical Stimulation as an Adjunct to Standard Treatment for Swallowing Disorders in Tracheotomized Patients Following Prolonged Mechanical Ventilation Weaning","SWALEC","Inclusion Criteria:\n\n* Hospitalized in intensive care units, post-ICU rehabilitation, or weaning and rehabilitation services;\n* Presence of a tracheostomy for more than 72 hours due to difficult mechanical ventilation weaning;\n* Diagnosis of swallowing disorders (swallowing fiberoscopy);\n* Patient aged at least 18 years at the time of inclusion;\n* Affiliated to a social security scheme or beneficiary of such a scheme;\n* Written, free and informed consent of the patient or their next of kin.\n\nExclusion Criteria:\n\n* Contra- indication to cervical NMES;\n* History of swallowing disorders;\n* Patient with a spinal cord injury above C5 level;\n* History of head and neck cancer;\n* Person under legal protection measures;\n* Patient under guardianship or conservatorship;\n* Known pregnancy;\n* Limitation of care.","ALL","18 Years",{"count":20,"type":21},238,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nManagement 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).\n\nPatients 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.",[27,28],"Dysphagia","NeuroMuscular Electrical Stimulation",[30],"Deglutition","NOT_YET_RECRUITING","2026-04-09",{"date":34,"type":35},"2026-04-14","ACTUAL",{"date":37,"type":21},"2026-03-26",{"date":39,"type":21},"2028-06-30",{"name":41,"class":42},"Hopital Forcilles","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100518638","prevalence-of-tapias-syndrome-in-weaning-unit-100518638","NCT06033144","Prevalence of Tapia's Syndrome in Weaning Unit","Prevalence of Tapia's Syndrome in Weaning Unit and Associated Factors After Orotracheal Intubation in the ICU","PRESTIO","Inclusion Criteria:\n\n* Hospitalized in weaning unit\n* Duration of orotracheal intubation in the ICU greater than 48 hours;\n* Glasgow score greater than or equal to 13 ;\n* Patient at least 18 years of age at the time of inclusion;\n* Affiliation with a social security system or beneficiary of such a system ;\n* Oral, free, informed and express consent of the patient.\n\nExclusion Criteria:\n\n* Known history of ENT or neurological pathologies (stroke, head trauma, neurodegenerative disease, brain tumor, ENT cancer);\n* Known tumors in the vicinity of the X-nerve pathway;\n* Ortner's syndrome (left recurrent nerve compression through the left atrium in mitral stenosis);\n* Left lung cancer with subaortic lesion;\n* History of cervical adenopathy compressing the X nerve;\n* Presence of a cervical or cerebral abscess;\n* 24-hour ventilated patient;\n* Refusal of the patient or designated trusted person to participate in the study;\n* Person subject to a safeguard of justice measure ;",{"count":52,"type":21},247,"OBSERVATIONAL","Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of tongue. This damage is most often unilateral but it can also be bilateral. It results in dysphonia and swallowing disorders.\n\nTapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have been described in the literature. Previous works are mainly case reports and literature reviews. No prevalence study has been performed to date. Furthermore, disagreements persist regarding the semiology. Indeed, the involvement of the soft palate is not always described.",[56],"Tapia's Syndrome","RECRUITING","2025-09-09",{"date":60,"type":35},"2025-09-15",{"date":62,"type":35},"2023-04-07",{"date":64,"type":21},"2027-04-07",{"name":41,"class":42},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":66},"100545829","radiation-related-dysphagia-development-prediction-using-a-two-step-ultrasonographic-model-r-2d-2-100545829","NCT06387004","Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2)","Evaluation of the Prognostic Value of Aerodigestive Tract Ultrasound in the Occurrence of Radiotherapy-related Swallowing Disorders in Head and Neck Cancer Patients","R-2D-2","Inclusion Criteria:\n\n* Patients admitted to Hôpital Forcilles for head and neck cancer radiotherapy;\n* Ultrasound operator available ;\n* Patient at least 18 years old at the time of inclusion;\n* Membership of a social security scheme or beneficiary of such a scheme ;\n* Oral, free, informed and express patient consent.\n\nExclusion Criteria:\n\n* Patients with neurological disorders;\n* Patients with DR before the start of radiotherapy;\n* Patient's refusal to participate in the study ;\n* Person subject to a safeguard of justice measure ;\n* Patient under guardianship;\n* Patient with limited care.",{"count":76,"type":21},112,"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.\n\nClinical 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.\n\nUltrasound 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.\n\nOver 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.\n\nThe 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.",[79],"Swallowing Disorders",[81,82,83,84],"Swallowing disorders","Echography","Prediction model","head and neck cancer","2025-01-17",{"date":87,"type":35},"2025-01-22",{"date":89,"type":35},"2024-01-18",{"date":91,"type":21},"2026-02-18",{"name":41,"class":42},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":5},"100564502","a-new-ultrasound-score-for-swallowing-disorders-diagnosis-in-difficult-to-wean-tracheostomised-patients-100564502","NCT06630013","A New Ultrasound Score for Swallowing Disorders Diagnosis in Difficult-to-wean Tracheostomised Patients","Construction and Evaluation of a New Ultrasound Score for the Diagnosis of Swallowing Disorders in Difficult-to-wean Tracheostomised Patients","SHUBACA","Inclusion Criteria:\n\n* Patients admitted to ICU and tracheostomised for difficult-to-wean reasons ;\n* Patients with a medical indication for nasofibroscopy ;\n* Medical prescription for physiotherapy assessment ;\n* Ultrasound operator available ;\n* Patient at least 18 years old at the time of inclusion;\n* Oral, free, informed and express patient consent\n\nExclusion Criteria:\n\n* Patient with total laryngectomy;\n* History of swallowing disorders prior to critical care admission;\n* History of central nervous system disorders (stroke, Parkinson's disease, etc.)\n* Patient admitted to intensive care following central neurological injury;\n* Patient with spinal cord injury above C5 ;\n* Patient's refusal to participate in the study ;\n* Known pregnancy ;\n* Cognitive impairment incompatible with understanding instructions;\n* Patient under guardianship;\n* Patient with limited care.",true,{"count":103,"type":21},114,"Swallowing Disorders (SD) is commonly observed in intensive care unit (ICU) patients.\n\nDisruption to the upper airway by way of a tracheostomy may lead to physiological and\u002For biomechanical changes to the swallow, thereby increasing dysphagia risk. SD is independently associated with adverse outcomes including respiratory complications, nutritional compromise, and even death.\n\nExperts recommend a systematic bedside screening. Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening positive patients.\n\nHowever, 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.\n\nIn 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.\n\nThe 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.\n\nDuring 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.\n\nAll 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.\n\nA 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.\n\nThe 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.",[106],"Deglutition Disorders","2024-10-04",{"date":109,"type":35},"2024-10-08",{"date":111,"type":35},"2024-07-09",{"date":113,"type":21},"2026-04-01",{"name":41,"class":42},""]