AI-Based Dysphagia Rehabilitation Program: Development and Validation

NCT07767123 | Not Yet Recruiting

• 1 other identifier: 120603022006
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

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

Interventions

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.

Optimized methods; Standard methods

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.

Optimized methods; Standard methods

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Center for Rehabilitation Technical Aids: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Pengxu Wei

  National Research Center for Rehabilitation Techincal Aids

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Sun

CONTACT

86-10-58122959; ekangfu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share