Clinical trial · Observational
Use of the Passy Muir Swallowing Self Trainer
Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia
NCT02848664CI-TRIAL-00037525completedResults 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)
The purpose of this study is to develop appropriate training methods and gather participant feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST is a small device that provides external vibratory stimulation to the larynx during swallowing and swallowing training. A secondary purpose of the study is to determine how 3 months of use of the PMSST affects swallowing physiology, brain activation, oral intake and quality of life. This was an uncontrolled pilot study aimed at gaining patient feedback on use of the vibratory device.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injury | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dysphagia retraining with device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Dysphagia retraining with device
- description
- Participants with dysphagia received baseline testing of dysphagia and dysphagia handicap. Then received training on how to use a vibrotactile device for self training at home. They used the device for 3 months and returned for re-evaluation on testing of dysphagia and feedback on the device
- interventionNames
- Device: Dysphagia retraining with device
Primary outcomes (2)
- measure
- Change in Dysphagia Outcome and Severity Scale (DOSS) Rating
- timeFrame
- From before onset of device use to return 3 months later
- description
- An ordinal scale of 7 levels of severity of swallowing disorder with 1 being the lowest level and 7 being the highest level. Level 1 is Severe dysphagia Nothing per oral and unable to tolerate any per oral liquid/substance safely. Level 2 is Moderately severe dysphagia, requires maximum assistance or use of strategies with partial per oral only, tolerates at least one consistency safely with total use of strategies. Level 3 is Moderate Dysphagia, requires total assist, supervision, or strategies with two or more consistencies restricted. Level 4 is Mild-moderate Dysphagia, Requires intermittent supervision/cueing, one or two consistencies restricted level 5 is Mild dysphagia: requires distant supervision may need one diet consistency restricted Level 6 Within functional limits, modified independence Level 7 Normal in all situations
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 13 years or older * Stable medical condition * Diagnosed with oropharyngeal dysphagia confirmed by Modified Barium Swallow (MBS) baseline measure of the follow two scales: 1. Penetration-Aspiration Scale score of 2 or greater verified by modified barium swallow (Rosenbek et al., 1996) and/or 2. Functional Oral Intake Scale score of 5 or lower (Crary et al., 2005) * Folstein Mini-Mental State Examination (MMSE) score of 23 or greater indicating cognitive ability to follow directions and communicate preferences * Willingness to travel to Sentara Rockingham Memorial Hospital 2 or more times to undergo initial evaluation, device use training and checkup at 3 months. Exclusion Criteria: * Pregnancy * Cardiac problems * history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia) * cardiac pacemaker in place * Highly-pigmented (dark) skin color is an exclusion criterion because near-infrared spectroscopy requires the measurement of the degree of absorption of different wavelengths of light after being reflected back through the scalp. Highly pigmented skin interferes with wavelength transmission, making the measurement of changes in absorption inaccurate. * Lack of a primary care physician who can be contacted if there are findings on the Magnetic Resonance Imaging (MRI) scan. * Presence of metal in the body (prostheses, electrodes, shrapnel, aneurism clips, other medical hardware) * Presence of certain tattoos with ferromagnetic metal or permanent makeup, due to the exposure to high magnetic force through MRI procedures. * Subjects who were metal workers as a previous occupation will also be excluded due to the possibility of unknown/undetected metal in their body. * Volunteers with broken skin in the area that the functional Near Infra-Red Spectroscopy (fNIRS) probes will be placed on the scalp * Claustrophobia * Previous surgery that used surgical staples * Artificial joints
References
Publications (2)
- BACKGROUNDMulheren RW, Ludlow CL. Vibration over the larynx increases swallowing and cortical activation for swallowing. J Neurophysiol. 2017 Sep 1;118(3):1698-1708. doi: 10.1152/jn.00244.2017. Epub 2017 Jul 5. PMID 28679839
- BACKGROUNDHegyi Szynkiewicz S, Mulheren RW, Palmore KW, O'Donoghue CR, Ludlow CL. Using devices to upregulate nonnutritive swallowing in typically developing infants. J Appl Physiol (1985). 2016 Oct 1;121(4):831-837. doi: 10.1152/japplphysiol.00797.2015. Epub 2016 Jul 28. PMID 27471240