[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651988":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":11,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":11,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":11},{"fullName":5,"class":6},"National Research Center for Rehabilitation Technical Aids","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Optimized methods","EXPERIMENTAL",null,[13,14],"Device: Neuromuscular electrical stimulation for swallowing","Diagnostic Test: Multi-sensor swallowing screening for dysphagia",{"label":16,"type":17,"description":11,"interventionNames":18},"Standard methods","ACTIVE_COMPARATOR",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Neuromuscular electrical stimulation for swallowing","Participants receive neuromuscular electrical stimulation (NMES) applied to swallowing-related muscles as part of swallowing rehabilitation. The stimulation parameters are individualized using an AI-assisted optimization process. The AI model analyzes swallowing assessment data, including FEES findings and multi-sensor signals, to select parameters expected to improve swallowing. The selected parameters are then applied. This intervention differs from conventional methods because the stimulation parameters are not selected solely by clinician experience, but are optimized by an AI-assisted system based on the participant's swallowing assessment results.",[9,16],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DIAGNOSTIC_TEST","Multi-sensor swallowing screening for dysphagia","Participants undergo a multi-sensor screening test for dysphagia. During swallowing, signals are collected from multiple sensors, such as surface electromyography, acoustic sensors, oxygen saturation, and respiratory sensors. The signals are analyzed using AI-assisted algorithms to identify patterns associated with swallowing impairment and aspiration risk. This approach provides objective, quantitative swallowing assessment and may be compared with FEES. It differs from conventional bedside screening and FEES by combining multiple physiological signals.",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Pengxu Wei","National Research Center for Rehabilitation Techincal Aids","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Dr. Sun","CONTACT","86-10-58122959","ekangfu@163.com",{"type":34,"investigatorFullName":32,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"director","100651988","ai-based-dysphagia-rehabilitation-program-development-and-validation-100651988",false,"NCT07767123","AI-Based Dysphagia Rehabilitation Program: Development and Validation","Development and Validation of an Artificial Intelligence-Based Rehabilitation Program for Dysphagia","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Diagnosed with dysphagia, confirmed by clinical screening (e.g., abnormal Water Swallow Test) or instrumental assessment (e.g., FEES);\n3. Conscious and alert, without severe cognitive impairment, and capable of understanding instructions and cooperating with swallowing function assessments and rehabilitation therapy;\n4. Provision of informed consent, with the informed consent form signed by the patient or their legal representative.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years;\n2. Presence of impaired consciousness, coma, or severe cognitive impairment, rendering the patient unable to understand instructions or cooperate with assessments and treatments;\n3. Presence of severe psychiatric disorders, behavioral abnormalities, or severe aphasia\u002Fhearing impairment, preventing cooperation with swallowing function assessment and therapy;\n4. Presence of severe anatomical abnormalities of the upper respiratory or digestive tract (e.g., laryngeal\u002Fesophageal tumors, recent major head and neck surgery), which contraindicate FEES or conventional swallowing therapy;\n5. Medically unstable conditions (e.g., severe respiratory distress, hemodynamic instability, acute infection phase), rendering the patient unable to tolerate assessments or rehabilitation therapy;\n6. Temporary dysphagia caused by acute, reversible factors (e.g., acute alcohol or drug intoxication);\n7. Any other conditions deemed by the investigator as inappropriate for participation in this study.",true,"ALL","18 Years",{"count":54,"type":55},30,"ESTIMATED","INTERVENTIONAL",[58],"NA","The goal of this clinical study is to learn if an artificial intelligence (AI)-assisted swallowing rehabilitation program can improve swallowing function in adults with dysphagia. It will also learn whether this approach can better detect aspiration (food or liquid entering the airway) and improve eating ability. The main questions it aims to answer are:\n\nCan AI-assisted analysis help identify swallowing treatment parameters that improve swallowing right away?\n\nDoes an optimized AI-assisted swallowing treatment work better than standard treatment parameters over 6 weeks?\n\nCan AI using data from sensors detect aspiration accurately?\n\nResearchers will compare swallowing function before and after treatment. They will also compare optimized treatment parameters selected with AI and FEES (a camera-based swallowing test) with standard treatment parameters. In addition, researchers will compare AI model results with FEES findings to see how well the sensors can identify aspiration.\n\nParticipants will:\n\nComplete swallowing assessments, including FEES, drinking tests, and swallowing questionnaires.\n\nHave small sensors placed to record muscle activity, sound, oxygen levels, and breathing while swallowing.\n\nReceive swallowing rehabilitation over 6 weeks, with treatment given in 1-week periods. During each period, treatment will be randomly assigned as either optimized parameters or standard parameters.\n\nComplete swallowing assessments after treatment periods to measure changes in swallowing function and eating ability.",[61],"Dysphagia","NOT_YET_RECRUITING","2026-08-16",{"date":65,"type":66},"2026-08-19","ACTUAL",{"date":68,"type":55},"2026-08",{"date":70,"type":55},"2027-12",{"name":5,"class":6}]