Use of the Passy Muir Swallowing Self Trainer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 13 - 100 |
| Updated: | 3/13/2019 |
| Start Date: | August 2013 |
| End Date: | August 2015 |
Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia
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.
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.
The investigators are currently developing the Passy Muir Swallowing Self-Trainer to continue
treatment of dysphagia after the patient is discharged to home. The self-training device is
worn around the neck with motors placed externally on the skin over the thyroid cartilage to
provide vibratory stimulation to the larynx. The vibrations activate the sensory receptors
inside the larynx which excite central nervous system (CNS) control for swallowing and can
help the patient to initiate swallowing. Patients can use the self-training device at home to
promote swallowing rehabilitation during daily swallowing practice. The device can also be
programmed to vibrate at regular intervals throughout the day to promote saliva swallows.
Using this method, the patient can continue their swallowing therapy independently and in a
manner that is cost effective. A previous Phase I trial compared the clinical outcomes of 8
patients with chronic dysphagia using either an intramuscular electrical stimulation implant
device or an external vibratory stimulator to practice swallowing daily at home. Functional
outcomes of oral intake improved with both devices. As the external vibratory stimulation has
the advantage of being external and completely noninvasive, it has been selected for further
development as a self-training device. A second pilot study examined the effect of different
frequencies of vibration on the swallowing frequency of healthy participants and found
swallowing rate significantly increased from baseline when using a vibration of either 70 Hz
or 150 Hz (Mulheren and Ludlow, 2017). Data has also been collected on the effect of
different vibration characteristics on swallowing in participants who have swallowing
problems after stroke (Kamarunas et al., in press).
Purpose: The purpose of this study is to allow patients with chronic dysphagia to use the
Self-Trainer for daily swallowing practice in their home and collect feedback on device use
and satisfaction and use. Objective information on the effectiveness of self-training for
swallowing rehabilitation will also be gathered.
Objectives:
1. To develop and evaluate training for participants and caregivers to use the
self-trainer.
2. To gather participant feedback on the use of the device after 3 months of daily
practice.
3. To determine how 3 months of daily practice with the Passy Muir Swallowing Self-Trainer
affects swallowing physiology, brain activation, oral intake, and quality of life in
participants with chronic dysphagia.
treatment of dysphagia after the patient is discharged to home. The self-training device is
worn around the neck with motors placed externally on the skin over the thyroid cartilage to
provide vibratory stimulation to the larynx. The vibrations activate the sensory receptors
inside the larynx which excite central nervous system (CNS) control for swallowing and can
help the patient to initiate swallowing. Patients can use the self-training device at home to
promote swallowing rehabilitation during daily swallowing practice. The device can also be
programmed to vibrate at regular intervals throughout the day to promote saliva swallows.
Using this method, the patient can continue their swallowing therapy independently and in a
manner that is cost effective. A previous Phase I trial compared the clinical outcomes of 8
patients with chronic dysphagia using either an intramuscular electrical stimulation implant
device or an external vibratory stimulator to practice swallowing daily at home. Functional
outcomes of oral intake improved with both devices. As the external vibratory stimulation has
the advantage of being external and completely noninvasive, it has been selected for further
development as a self-training device. A second pilot study examined the effect of different
frequencies of vibration on the swallowing frequency of healthy participants and found
swallowing rate significantly increased from baseline when using a vibration of either 70 Hz
or 150 Hz (Mulheren and Ludlow, 2017). Data has also been collected on the effect of
different vibration characteristics on swallowing in participants who have swallowing
problems after stroke (Kamarunas et al., in press).
Purpose: The purpose of this study is to allow patients with chronic dysphagia to use the
Self-Trainer for daily swallowing practice in their home and collect feedback on device use
and satisfaction and use. Objective information on the effectiveness of self-training for
swallowing rehabilitation will also be gathered.
Objectives:
1. To develop and evaluate training for participants and caregivers to use the
self-trainer.
2. To gather participant feedback on the use of the device after 3 months of daily
practice.
3. To determine how 3 months of daily practice with the Passy Muir Swallowing Self-Trainer
affects swallowing physiology, brain activation, oral intake, and quality of life in
participants with chronic dysphagia.
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
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