Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 80

Digital Tongue-Pressure Biofeedback Training for Post-Stroke Swallowing

Official title: Digital Intelligent Tongue-Pressure Biofeedback Resistance Training for Post-Stroke Dysphagia: A Randomized Controlled Trial

Run by First People's Hospital of Foshan · NCT07798401 · Data updated 2026-11-12

This study tests whether digital tongue-pressure biofeedback training helps people with swallowing difficulties after stroke.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment80 (estimated)
SponsorFirst People's Hospital of Foshan
Academic / other
Locations1 site (Foshan, Guangdong)
StatusRecruiting
StartedJune 5, 2026
Main results expectedDecember 30, 2028
Study endsDecember 30, 2028
Registry record updatedSeptember 1, 2026
Trial IDNCT07798401 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with post-stroke dysphagia who can participate in tongue-pressure training and meet safety criteria.

Probably not a fit

Patients with severe cognitive impairment, oral disorders, or allergies to device materials may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter trial compares digital intelligent tongue-pressure biofeedback resistance training plus standard swallowing rehab versus standard rehab alone in adults with post-stroke dysphagia. The study hopes to see if real-time feedback improves tongue strength and swallowing function. It will enroll about 80 participants, randomly assigning them to intervention or control in a parallel design. The trial is open-label and assesses outcomes related to swallowing and safety during the treatment period.

Why it matters

Potential benefit: If successful, patients could experience improved swallowing function and reduced risk of pneumonia and malnutrition.

How similar studies have gone: Previous tongue-pressure training studies suggest potential benefits, but this digital biofeedback approach is a newer, more individualized method.

Who can join: the full rules

Show full inclusion / exclusion criteria
clusion Criteria:

1. Subarachnoid hemorrhage, transient ischemic attack, progressive stroke, reversible ischemic neurological deficit, or neurodegenerative disease.
2. Unable to complete tongue-pressure measurement or tongue-pressure resistance training, including participants with severe psychiatric disorders, severe cognitive impairment (Mini-Mental State Examination \[MMSE\] score \<18), oral structural abnormalities, or severe oral disease.
3. Known allergy or hypersensitivity to materials used in the study device.
4. Pregnant or breastfeeding, or planning pregnancy during the study period.
5. Participation in another medical device or drug clinical trial within the previous 1 month or current participation in another such trial.
6. Any other condition that, in the investigator's judgment, may result in poor compliance or make the participant unsuitable for the study.

Where it's running

  • First People's Hospital of Foshan
    Foshan, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.