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NCT Number: NCT07767123

AI-Based Dysphagia Rehabilitation Program: Development and Validation

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • Diagnosed with dysphagia, confirmed by clinical screening (e.g., abnormal Water Swallow Test) or instrumental assessment (e.g., FEES);
  • Conscious and alert, without severe cognitive impairment, and capable of understanding instructions and cooperating with swallowing function assessments and rehabilitation therapy;
  • Provision of informed consent, with the informed consent form signed by the patient or their legal representative.

Exclusion criteria

  • Age < 18 years;
  • Presence of impaired consciousness, coma, or severe cognitive impairment, rendering the patient unable to understand instructions or cooperate with assessments and treatments;
  • Presence of severe psychiatric disorders, behavioral abnormalities, or severe aphasia/hearing impairment, preventing cooperation with swallowing function assessment and therapy;
  • Presence of severe anatomical abnormalities of the upper respiratory or digestive tract (e.g., laryngeal/esophageal tumors, recent major head and neck surgery), which contraindicate FEES or conventional swallowing therapy;
  • Medically unstable conditions (e.g., severe respiratory distress, hemodynamic instability, acute infection phase), rendering the patient unable to tolerate assessments or rehabilitation therapy;
  • Temporary dysphagia caused by acute, reversible factors (e.g., acute alcohol or drug intoxication);
  • Any other conditions deemed by the investigator as inappropriate for participation in this study.

Treatment and study plan

Neuromuscular electrical stimulation for swallowing

Device

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.

Multi-sensor swallowing screening for dysphagia

Diagnostic Test

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.

Primary outcomes

  1. Change in Penetration-Aspiration Scale (PAS) Score

    Time frame: Baseline to 6 weeks.

    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.

  2. Change in Pharyngeal Residue Severity

    Time frame: Baseline to 6 weeks

    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.

Secondary outcomes

  1. Change in Functional Oral Intake Scale (FOIS) Score

    Time frame: Baseline to 6 weeks

    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).

  2. Change in Eating Assessment Tool-10 (EAT-10) Score

    Time frame: Baseline to 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Sun

CONTACT

[email protected]

86-10-58122959

Sponsors and collaborators

Lead sponsor

National Research Center for Rehabilitation Technical Aids

Other

Registry information

Official study title

Development and Validation of an Artificial Intelligence-Based Rehabilitation Program for Dysphagia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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