Clinical trial · Observational
The Passy Muir Swallowing Self Training Device
Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke
NCT01765673CI-TRIAL-00030344PMSSTcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Dysphagia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vibrotactile stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Vibrotactile Stimulation in Dysphagia
- description
- A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort.
- interventionNames
- Device: Vibrotactile stimulation
Primary outcomes (5)
- measure
- Change in Swallow Frequency 30 Hz
- timeFrame
- During one session within 1 hour
- description
- Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
- measure
- Change in Swallow Frequency 70 Hz
- timeFrame
- During one session within 1 hour
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Stroke or post radiation for the treatment of head and neck cancer * Dysphagia with a score of 2 or greater on the Penetration/Aspiration Scale OR a Mann Assessment of Swallowing Ability ordinal risk rating of "probable" or "definite" Exclusion Criteria: * Neck injury * Epilepsy * Neurological disorder other than stroke * Psychiatric illness other than depression * Uncontrolled gastroesophageal reflux disease * Inability to communicate secondary to significant speech or language problems * Inability to maintain alertness for 1 hour * Significant health concerns that would put the participant at risk
References
Publications (2)
- RESULTTheurer JA, Bihari F, Barr AM, Martin RE. Oropharyngeal stimulation with air-pulse trains increases swallowing frequency in healthy adults. Dysphagia. 2005 Fall;20(4):254-60. doi: 10.1007/s00455-005-0021-1. PMID 16633868
- RESULTTheurer JA, Czachorowski KA, Martin LP, Martin RE. Effects of oropharyngeal air-pulse stimulation on swallowing in healthy older adults. Dysphagia. 2009 Sep;24(3):302-13. doi: 10.1007/s00455-009-9207-2. Epub 2009 Apr 24. PMID 19390893