NCT07782424|Not Yet Recruiting
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Sponsor study identifier
interventional
80
0 countries
N/A
Study Start
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 19, 2026
Actual (reported)August 24, 2026
Actual (reported)December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Baseline and immediately after completion of the 2-week intervention
Penetration-Aspiration Scale (PAS) Score
Baseline and immediately after completion of the 2-week intervention
Dysphagia Outcome and Severity Scale (DOSS) Score
Baseline and immediately after completion of the 2-week intervention
Oral Transit Time (OTT)
Baseline and immediately after completion of the 2-week intervention
Upper Esophageal Sphincter Opening (UO)
Baseline and immediately after completion of the 2-week intervention
Hyoid Superior Movement (HSM)
Baseline and immediately after completion of the 2-week 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.
Clave P, Ortega O, Rofes L, Alvarez-Berdugo D, Tomsen N. Brain and Pharyngeal Responses Associated with Pharmacological Treatments for Oropharyngeal Dysphagia in Older Patients. Dysphagia. 2023 Dec;38(6):1449-1466. doi: 10.1007/s00455-023-10578-x. Epub 2023 May 5.
Theurer JA, Johnston JL, Fisher J, Darling S, Stevens RC, Taves D, Teasell R, Hachinski V, Martin RE. Proof-of-principle pilot study of oropharyngeal air-pulse application in individuals with dysphagia after hemispheric stroke. Arch Phys Med Rehabil. 2013 Jun;94(6):1088-94. doi: 10.1016/j.apmr.2012.11.033. Epub 2012 Dec 5.
First Submitted
August 19, 2026
First Posted
August 24, 2026
Study Start
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Your Mind Can Exercise Too: Swallowing Motor Imagery Practice
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.
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Assoratgoon I, Shiraishi N, Tagaino R, Ogawa T, Sasaki K. Sensory neuromuscular electrical stimulation for dysphagia rehabilitation: A literature review. J Oral Rehabil. 2023 Feb;50(2):157-164. doi: 10.1111/joor.13391. Epub 2022 Nov 28.
Zhang M, Li C, Zhang F, Han X, Yang Q, Lin T, Zhou H, Tang M, Zhou J, Shi H, Hui Y, Xiong M, Pang L, Wang B, Feng Z, Li Z, Cao C, Lu X, Ding Y, Shen S, Xu Z, Yu F, Chen C, Meng L, Liao G, Zhang J, Sasegbon A, Dou Z. Prevalence of Dysphagia in China: An Epidemiological Survey of 5943 Participants. Dysphagia. 2021 Jun;36(3):339-350. doi: 10.1007/s00455-020-10138-7. Epub 2020 May 26.
December 31, 2029
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 24, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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