Mechanisms of Air-pulse Pharyngeal Sensory Stimulation Regulation Post-stroke Swallowing Neural Network Remodeling Via TRPV4 Channel

August 20, 2026 updated by: Zhiming Tang, First People's Hospital of Foshan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Diagnosis of stroke according to the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases.
  2. Dysphagia confirmed by videofluoroscopic swallowing study (VFSS) or fiberoptic endoscopic evaluation of swallowing (FEES).
  3. Functional Oral Intake Scale (FOIS) score of 1-5.
  4. Stable vital signs.
  5. Time since stroke onset of at least 1 month.
  6. Age 18-76 years.
  7. No severe impairment of auditory comprehension and able to cooperate with study procedures.
  8. Written informed consent provided by the participant and/or family member, as applicable.

Exclusion Criteria:

  1. Other neurological or mental system disorders
  2. Severe sensory impairment.
  3. Severe cardiac, pulmonary, hepatic, or renal disease.
  4. History of seizures after stroke.
  5. Allergy in the relevant treatment area, or other contraindications to the study stimulation procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Pharyngeal Air-Pulse Sensory Stimulation
Device: Air-Pulse Sensory Stimulation
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 Comparator: Sham Pharyngeal Air-Pulse Sensory Stimulation
Device: sham intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Functional Oral Intake Scale (FOIS)
Time Frame: Baseline and immediately after completion of the 2-week intervention
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
Baseline and immediately after completion of the 2-week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Penetration-Aspiration Scale (PAS) Score
Time Frame: Baseline and immediately after completion of the 2-week intervention
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.
Baseline and immediately after completion of the 2-week intervention
Dysphagia Outcome and Severity Scale (DOSS) Score
Time Frame: Baseline and immediately after completion of the 2-week intervention
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.
Baseline and immediately after completion of the 2-week intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oral Transit Time (OTT)
Time Frame: Baseline and immediately after completion of the 2-week intervention
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.
Baseline and immediately after completion of the 2-week intervention
Upper Esophageal Sphincter Opening (UO)
Time Frame: Baseline and immediately after completion of the 2-week intervention
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.
Baseline and immediately after completion of the 2-week intervention
Hyoid Superior Movement (HSM)
Time Frame: Baseline and immediately after completion of the 2-week intervention
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.
Baseline and immediately after completion of the 2-week intervention
Hyoid Anterior Movement (HAM)
Time Frame: Baseline and immediately after completion of the 2-week intervention
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.
Baseline and immediately after completion of the 2-week intervention
Laryngeal Closure Duration (LCD)
Time Frame: Baseline and immediately after completion of the 2-week intervention
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.
Baseline and immediately after completion of the 2-week intervention
Pharyngeal Transit Time (PTT)
Time Frame: Baseline and immediately after completion of the 2-week intervention
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.
Baseline and immediately after completion of the 2-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First People's Hospital of Foshan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FSYYY-EC-SOP-008-03.0-A08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings