An interventional study of Air-Pulse Sensory Stimulation and sham intervention in Dysphagia, sponsored by First People's Hospital of Foshan. Not yet recruiting. Open to participants aged 18 Years to 76 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by First People's Hospital of Foshan · Not applicable, Interventional, and Treatment
This randomized, double-blind, sham-controlled clinical trial will investigate the effects and potential neural mechanisms of pharyngeal air-pulse sensory stimulation in patients with post-stroke dysphagia. A total of 80 participants with swallowing impairment after stroke will be randomly assigned in a 1:1 ratio to either an active stimulation group or a sham stimulation group. Both groups will receive conventional swallowing rehabilitation, while the active group will additionally receive pharyngeal air-pulse sensory stimulation and the control group will receive sham stimulation for 2 weeks.
Swallowing function and neurophysiological changes will be assessed before and after the intervention. Assessments will include clinical swallowing evaluations, videofluoroscopic swallowing study, surface electromyography, resting-state and task-based functional magnetic resonance imaging, and diffusion kurtosis imaging. The study aims to determine whether pharyngeal air-pulse sensory stimulation can improve swallowing function and to explore associated changes in swallowing-related sensory-motor brain networks after stroke.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →First People's Hospital of Foshan is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Air-Pulse Sensory Stimulation
Device: sham intervention
Active pharyngeal air-pulse sensory stimulation is delivered using a pharyngeal air-pulse sensory stimulation device. The stimulation site is the anterior wall of the piriform sinus or the aryepiglottic fold. Air-pulse stimulation is delivered at a frequency of 48 pulses per minute, with 1 minute of stimulation alternating with 1 minute of rest, for a total session duration of 20 minutes and approximately 480 air pulses per session.
Sham pharyngeal air-pulse sensory stimulation is delivered using the same device. The catheter insertion procedure, placement method, and duration are kept consistent with those used in the active stimulation group to maintain blinding.
The Functional Oral Intake Scale (FOIS)
The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale used to assess the functional level of oral food and liquid intake. Scores range from 1 (nothing by mouth) to 7 (total oral diet with no restrictions). Higher scores indicate better funct
Time frame: Baseline and immediately after completion of the 2-week intervention
Penetration-Aspiration Scale (PAS) Score
The Penetration-Aspiration Scale (PAS) is an 8-point ordinal scale used to assess the severity of airway invasion during swallowing. Scores range from 1 to 8, with a score of 1 indicating that material does not enter the airway and a score of 8 indicating that material passes below the vocal folds with no attempt to eject it. Higher scores indicate greater severity of penetration or aspiration.
Time frame: Baseline and immediately after completion of the 2-week intervention
Dysphagia Outcome and Severity Scale (DOSS) Score
The Dysphagia Outcome and Severity Scale (DOSS) is a 7-point ordinal scale used to assess the functional severity of dysphagia and the level of dietary restriction and assistance required. Scores range from 1 to 7, with a score of 1 indicating severe dysphagia with inability to safely tolerate oral intake and a score of 7 indicating normal swallowing with a regular diet and no need for compensatory strategies or additional time. Higher scores indicate better swallowing function and lower severity of dysphagia.
Time frame: Baseline and immediately after completion of the 2-week intervention
Oral Transit Time (OTT)
Oral Transit Time (OTT) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in seconds (s). OTT is defined as the time interval from the initiation of posterior oral bolus propulsion until the leading edge of the bolus reaches the ramus of the mandible. Measurements will be obtained using predefined bolus consistencies and volumes.
Time frame: Baseline and immediately after completion of the 2-week intervention
Upper Esophageal Sphincter Opening (UO)
Upper Esophageal Sphincter Opening (UO) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in millimeters (mm). UO is defined as the maximum opening diameter of the upper esophageal sphincter during bolus passage, measured on the lateral VFSS image at the point of maximal opening.
Time frame: Baseline and immediately after completion of the 2-week intervention
Hyoid Superior Movement (HSM)
Hyoid Superior Movement (HSM) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in millimeters (mm). HSM represents the maximum superior displacement of the hyoid bone from its resting position during swallowing.
Time frame: Baseline and immediately after completion of the 2-week intervention
Hyoid Anterior Movement (HAM)
Hyoid Anterior Movement (HAM) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in millimeters (mm). HAM represents the maximum anterior displacement of the hyoid bone from its resting position during swallowing.
Time frame: Baseline and immediately after completion of the 2-week intervention
Laryngeal Closure Duration (LCD)
Laryngeal Closure Duration (LCD) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in seconds (s). LCD is defined as the time interval from complete closure of the laryngeal vestibule to subsequent reopening of the laryngeal vestibule during swallowing. Measurements will be obtained using predefined bolus consistencies and volumes.
Time frame: Baseline and immediately after completion of the 2-week intervention
Pharyngeal Transit Time (PTT)
Pharyngeal Transit Time (PTT) will be measured from videofluoroscopic swallowing study (VFSS) recordings and expressed in seconds (s). PTT is defined as the time interval from the leading edge of the bolus passing the ramus of the mandible until the trailing edge of the bolus passes through the upper esophageal sphincter. A shorter PTT indicates faster pharyngeal bolus transport.
Time frame: Baseline and immediately after completion of the 2-week intervention
No study locations are listed for this record.
Plan to share: No
Start is estimated for Aug 2026; primary completion for Dec 2029, 40 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 40 months is above that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Foshan