NCT07767123|Not Yet Recruiting
AI-Based Dysphagia Rehabilitation Program: Development and Validation
Development and Validation of an Artificial Intelligence-Based Rehabilitation Program for Dysphagia
Loading search results
Development and Validation of an Artificial Intelligence-Based Rehabilitation Program for Dysphagia
Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 11, 2026
Actual (reported)August 17, 2026
Actual (reported)December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
Baseline to 6 weeks
Change in Functional Oral Intake Scale (FOIS) Score
Baseline to 6 weeks
Change in Eating Assessment Tool-10 (EAT-10) Score
Baseline to 6 weeks
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.
Pengxu Wei
National Research Center for Rehabilitation Techincal Aids
First Submitted
August 11, 2026
First Posted
August 17, 2026
Study Start
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 19, 2026
Record last verified: 2026-08
Sharing raw biometric and clinical datasets is restricted by institutional ethics board policies and local privacy regulations to protect patient confidentiality.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: