Clinical trial NCT02848664: Use of the Passy Muir Swallowing Self Trainer
Official title: Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Brain Injury
Head and Neck Cancer
Lead sponsor: James Madison University
Sponsor class: OTHER
Collaborators: name: Passy Muir Inc.
First posted: 2016-07-28
Enrollment: 11
Sex: ALL
Minimum age (years): 13
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic severe dysphagia requiring Percutaneous Endoscopic Gastrostomy (PEG) tube for nutrition

Brief 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.

Detailed description: 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.

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:

  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

Primary outcomes:
measure: Change in Dysphagia Outcome and Severity Scale (DOSS) Rating
timeFrame: From before onset of device use to return 3 months later
measure: Dysphagia Handicap Index (DHI)
timeFrame: From before onset of device use to return 3 months later
Secondary outcomes:
measure: Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure
timeFrame: From before onset of device use to return 3 months later
measure: Cortical Activation for Swallowing
timeFrame: From before onset of device use to return 3 months later
Other outcomes:
Locations:
city: Harrisonburg
country: United States
facility: James Madison University
state: Virginia
Study officials:
affiliation: James Madison University
name: Erin Kamarunas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mulheren 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.
citation: Hegyi 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.