N/A
N=11
Use of the Passy Muir Swallowing Self Trainer
Stroke · Brain Injury · Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02848664 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Change in Dysphagia Outcome and Severity Scale (DOSS) Rating — 5; 2 Participants — p=<0.025
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dysphagia retraining with device (Device)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- James Madison University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dysphagia Outcome and Severity Scale (DOSS) Rating |
5; 2 | <0.025 sig |
| PRIMARY Dysphagia Handicap Index (DHI) |
61.143; 38.571 | 0.016 sig |
| SECONDARY Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure |
5.525 | 0.046 sig |
| SECONDARY Cortical Activation for Swallowing |
18.042; 70.822 | 0.037 sig |
Summary
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.
Eligibility Criteria
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:
- Penetration-Aspiration Scale score of 2 or greater verified by modified barium swallow (Rosenbek et al., 1996) and/or
- 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
Data sourced from ClinicalTrials.gov (NCT02848664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.