An interventional study of Neuromuscular electrical stimulation for swallowing and Multi-sensor swallowing screening for dysphagia in Dysphagia, sponsored by National Research Center for Rehabilitation Technical Aids. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by National Research Center for Rehabilitation Technical Aids · Not applicable, Interventional, and Treatment
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:
Can AI-assisted analysis help identify swallowing treatment parameters that improve swallowing right away?
Does an optimized AI-assisted swallowing treatment work better than standard treatment parameters over 6 weeks?
Can AI using data from sensors detect aspiration accurately?
Researchers 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.
Participants will:
Complete swallowing assessments, including FEES, drinking tests, and swallowing questionnaires.
Have small sensors placed to record muscle activity, sound, oxygen levels, and breathing while swallowing.
Receive 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.
Complete swallowing assessments after treatment periods to measure changes in swallowing function and eating ability.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →National Research Center for Rehabilitation Technical Aids is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Neuromuscular electrical stimulation for swallowing · Diagnostic Test: Multi-sensor swallowing screening for dysphagia
Device: Neuromuscular electrical stimulation for swallowing · Diagnostic Test: Multi-sensor swallowing screening for dysphagia
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.
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.
Change in Penetration-Aspiration Scale (PAS) Score
The PAS is an 8-point scale derived from FEES (Flexible Endoscopic Evaluation of Swallowing) to quantify the depth and clearance of material entering the airway. A score of 1 indicates normal swallowing, while 8 indicates silent aspiration.
Time frame: Baseline to 6 weeks.
Change in Pharyngeal Residue Severity
Residue was assessed via FEES using the Yale Pharyngeal Residue Severity Rating Scale. This is a five-point ordinal rating scale based on residue location (vallecula and pyriform sinus) and amount (1: none, 2: trace, 3: mild, 4: moderate, and 5: severe), used to quantify post-swallow residue in the valleculae and pyriform sinuses across different consistencies.
Time frame: Baseline to 6 weeks
Change in Functional Oral Intake Scale (FOIS) Score
Oral intake status was assessed using a 7-point scale (Functional Oral Intake Scale \[FOIS\]), ranging from nothing by mouth (Level 1: most impaired) to a total oral diet with no restrictions (Level 7: most functional).
Time frame: Baseline to 6 weeks
Change in Eating Assessment Tool-10 (EAT-10) Score
A self-administered questionnaire assessing the severity of swallowing disorder symptoms and their impact on quality of life. Scores range from 0 to 40, with higher scores indicating worse symptoms.
Time frame: Baseline to 6 weeks
No study locations are listed for this record.
Plan to share: No — Sharing raw biometric and clinical datasets is restricted by institutional ethics board policies and local privacy regulations to protect patient confidentiality.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 16 months is below that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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National Research Center for Rehabilitation Technical Aids