DysphagiaNCT07767123
AI-Based Dysphagia Rehabilitation Program: Development and Validation
A study testing Neuromuscular electrical stimulation for swallowing and Multi-sensor swallowing screening for dysphagia in people with Dysphagia, run by National Research Center for Rehabilitation Technical Aids.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- Neuromuscular electrical stimulation for swallowing and Multi-sensor swallowing screening for dysphagia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Validation of an Artificial Intelligence-Based Rehabilitation Program for Dysphagia
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?
Read more
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.
- Conditions
- Dysphagia
- Being tested
- Neuromuscular electrical stimulation for swallowing, Multi-sensor swallowing screening for dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation for swallowingDevice
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 dysphagiaDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Optimized methods | Experimental | Not described Receives: Device: Neuromuscular electrical stimulation for swallowing; Diagnostic Test: Multi-sensor swallowing screening for dysphagia |
| Standard methods | Active comparator | Not described Receives: Device: Neuromuscular electrical stimulation for swallowing; Diagnostic Test: Multi-sensor swallowing screening for dysphagia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 6 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Rehabilitation Technical Aids
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pengxu Wei, National Research Center for Rehabilitation Technical Aids
- Investigators
- Pengxu Wei, Principal investigator, National Research Center for Rehabilitation Techincal Aids
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767123
- Sponsor's protocol ID
- 120603022006
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing raw biometric and clinical datasets is restricted by institutional ethics board policies and local privacy regulations to protect patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Artificial Intelligence-Based Rehabilitation Program for Dysphagia
- ClinicalTrials.gov ID
- NCT07767123
- Acronym / sponsor ID
- 120603022006
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Research Center for Rehabilitation Technical AidsUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized methods | Experimental | Device: Neuromuscular electrical stimulation for swallowing, Diagnostic Test: Multi-sensor swallowing screening for dysphagia |
| Standard methods | Active comparator | Device: Neuromuscular electrical stimulation for swallowing, Diagnostic Test: Multi-sensor swallowing screening for dysphagia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulation for swallowingParticipants 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. | Device | Optimized methods, Standard methods |
| Multi-sensor swallowing screening for dysphagiaParticipants 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. | Diagnostic test | Optimized methods, Standard methods |
Primary outcome
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.
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.
2 secondary outcomes
Change in Functional Oral Intake Scale (FOIS) Score
Time frame: Baseline to 6 weeks
Change in Eating Assessment Tool-10 (EAT-10) Score
Time frame: Baseline to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Sharing raw biometric and clinical datasets is restricted by institutional ethics board policies and local privacy regulations to protect patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pengxu Wei principal investigator
National Research Center for Rehabilitation Techincal Aids
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation for swallowing and Multi-sensor swallowing screening for dysphagia in people with Dysphagia, run by National Research Center for Rehabilitation Technical Aids.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Sun (86-10-58122959, ekangfu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Penetration-Aspiration Scale (PAS) Score (time frame: Baseline to 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.