Study of the Use of the Passy Muir Swallowing Self Trainer by Persons With Dysphagia
Conditions: Stroke, Brain Injury, Head and Neck Cancer
Sponsor: James Madison University

Institutional Review Board (IRB) 
 
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James Madison University   
                                                                                                                                           
 
 
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James Madison University 
Human Research Review Request 
FOR IRB USE ONLY: 
Exempt:  
 
Protocol Number: 
1st Review:   
 
Reviewer:   
 
 
 
 
 
 
 
Expedited:  
 
IRB:  
 
 
 
 
2nd Review:   
 
Reviewer:   
 
 
 
 
 
 
 
Full Board:  
 
Received:  
 
 
 
3rd Review:   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROJECT TITLE: 
Study of the Use of the Passy Muir Swallowing Self 
Trainer by Persons with Dysphagia 
 
PROJECT DATES (Not to exceed 
1 year minus 1 day): 
From: 07/29/13 
          MM/DD/YY   
To: 07/28/16 
    MM/DD/YY   
 
MINIMUM # OF PARTICIPANTS:  
      
MAXIMUM # OF PARTICIPANTS:        
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EXTERNAL FUNDING:  
Yes: 
 
No: 
 
If yes, Sponsor:      Passy Muir, cost of devices, patient travel and 
payment for participation  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RESPONSIBLE RESEARCHER(S): 
     Christy L. Ludlow, PhD, Erin Kamarunas, PhD 
E-MAIL ADDRESS: 
     ludlowcx@jmu.edu; kamaruee@jmu.edu 
TELEPHONE: 
      
DEPARTMENT: 
      
ADDRESS (MSC): 
      
 
PLEASE SELECT: 
 Faculty 
 
 Undergraduate Student 
 Administrator/Staff Member 
 Graduate Student 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(If Applicable):  
RESPONSIBLE ADVISOR: 
      
E-MAIL ADDRESS: 
      
TELEPHONE: 
      
DEPARTMENT: 
      
ADDRESS (MSC): 
      
 
Investigator:  Please respond to the questions below.  The IRB will utilize your responses to evaluate your protocol submission. 
  1. 
 YES  
 NO     Does the James Madison University Institutional Review Board define the project as research?  
The James Madison University IRB defines "research" as a "systematic investigation designed to develop or contribute to generalizable knowledge.”   All 
research involving human participants conducted by James Madison University faculty, staff, and students is subject to IRB review.   
 
2. 
 YES  
 NO     Are the human participants in your study living individuals? 
“Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human 
subjects are defined as: living individual(s) about whom an investigator conducting research obtains:  
(1) data through intervention or interaction with the individual; or (2) identifiable private information.”   
 
 
 3. 
 YES  
 NO     Will you obtain data through intervention or interaction with these individuals?  
“Intervention” includes both physical procedures by which data are gathered (e.g., measurement of heart rate or venipuncture) and manipulations of the 
participant or the participant's environment that are performed for research purposes.  “Interaction” includes communication or interpersonal contact between the 
investigator and participant (e.g., surveying or interviewing). 
 
  4.   
 YES  
 NO     Will you obtain identifiable private information about these individuals?  
"Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is 
taking place, or information provided for specific purposes which the individual can reasonably expect will not be made public (e.g., a medical record or student 
record).  "Identifiable" means that the identity of the participant may be ascertained by the investigator or associated with the information (e.g., by name, code 
number, pattern of answers, etc.). 
 
  5. 
 YES  
 NO     Does the study present more than minimal risk to the participants?  

Institutional Review Board (IRB) 
 
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"Minimal risk" means that the risks of harm or discomfort anticipated in the proposed research are not greater, considering probability and magnitude, than those 
ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests.  Note that the concept of risk goes beyond 
physical risk and includes psychological, emotional, or behavioral risk as well as risks to employability, economic well-being, social standing, and risks of civil and 
criminal liability.   
CERTIFICATIONS: 
For James Madison University to obtain a Federal Wide Assurance (FWA) with the Office of Human Research Protection (OHRP), U.S. Department of Health & Human 
Services, all research staff working with human participants must sign this form and receive training in ethical guidelines and regulations.  "Research staff" is defined as 
persons who have direct and substantive involvement in proposing, performing, reviewing, or reporting research and includes students fulfilling these roles as well as their 
faculty advisors.  The Office of Sponsored Programs maintains a roster of all researchers who have completed training within the past three years.  
Test module at OSP website http://www.jmu.edu/sponsprog/irb/irbtraining.html 
Name of Researcher(s) 
Training Completion Date 
Erin Kamarunas, PhD 
09/02/2013 
Christy Ludlow, PhD 
08/06/2013 
Seng Mun Wong 
11/08/2013 
Erin Staudt 
5/28/15 
For additional training interests visit the National Institutes of Health Web Tutorial at:  http://cme.nci.nih.gov/  
 
By signing below, the Responsible Researcher(s), and the Faculty Advisor (if applicable), certifies that he/she is familiar with the ethical guidelines and regulations 
regarding the protection of human research participants from research risks.  In addition, he/she agrees to abide by all sponsor and university policies and procedures 
in conducting the research.  He/she further certifies that he/she has completed training regarding human participant research ethics within the last three years. 
 
_________________________________________ 
________________ 
Principal Investigator Signature 
 
  
Date 
 
_________________________________________ 
________________ 
Principal Investigator Signature 
 
  
Date 
 
_________________________________________ 
________________ 
Principal Investigator Signature 
 
  
Date 
 
_________________________________________ 
________________ 
Principal Investigator Signature 
 
  
Date 
 
_________________________________________ 
________________ 
Faculty Advisor Signature 
 
  
Date 
 
Submit an electronic version of your ENTIRE protocol to jmu_grants@jmu.edu.  
Provide a SIGNED hard copy of the Research Review Request Form to:  
Office of Sponsored Programs, MSC 5728, James Madison Administrative Complex, Bldg #6, Suite 26 

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Figure 1. The Passy-Muir Swallowing 
Self-Training device is worn around 
the neck with the motors making 
contact with either side of the 
thyroid cartilage. These motors 
vibrate to stimulate the sensory 
nerves that induce swallowing.  
Figure 2: the 70/110 Hz motor increased 
swallowing by 100% or more in all healthy 
Background: 
Over 60% of patients who have a stroke will experience secondary problems with their swallowing (dysphagia) 
(Mann et al., 1999). However, at least half of acute stroke patients will discharge to home with limited follow up on their 
swallowing problem (Howrey et al., 2011), which can lead to severe consequences. Similar problems with need for 
continued access to swallowing therapy occur following treatment of head 
and neck cancer where patients usually experience swallowing difficulties 
following chemoradiation and surgery (Hutcheson et al., 2012; Hutcheson & 
Lewin, 2012). Patients with swallowing disorders following traumatic brain 
injury also usually require a prolonged period of rehabilitation (Hansen et al., 
2008). Once patients are discharged to home, limited access and cost issues 
are often barriers to continuing swallowing rehabilitation and consequently 
the patient’s swallowing problem is chronically untreated. This not only 
negatively impacts the patient’s quality of life and their ability to eat an oral 
diet, it fails to address chronic aspiration that can lead to rehospitalization 
and death. Continuing dysphagia care immediately following discharge is 
extremely important as earlier treatment leads to better outcomes 
(Odderson et al., 1995).  
We 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 (Figure 1). The vibrations activate the sensory receptors inside the larynx which excite CNS control for swallowing 
(Chi-Fishman, 1994) 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 (FDA IDE G0G0153). 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 (IRB-
12-0057) examined the effect of different frequencies of 
vibration on the swallowing frequency of healthy 
participants and found swallowing significantly increased 
from baseline when using a vibration of 70 Hz on one side 
of the larynx and 110 Hz on the other side (Figure 2). Data 
is currently being collected on the effect of different 
vibration characteristics on swallowing in participants 
who have swallowing problems after stroke (IRB-13-
0010).  
 
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.  
 

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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.   
 
Procedures/Research Design/Methodology/Timeframe 
Design: This study is a case series study of participants using the device to evaluate patient preferences such as 
frequency of device use, compliance with training guidelines, patient and caregiver training required for appropriate 
use, and patient and caregiver feedback on satisfaction with the device. All participants will continue any outpatient 
rehabilitation they are receiving during this time period. This research will determine device training and use parameters 
before designing a Phase II controlled trial of the degree of benefit from device use. All participants and their caregivers 
will be trained on correct use of the Swallowing Self-Trainer and will use the device to practice swallowing in their home 
environment for 3 months (months 1-3). Each participant will complete the outcomes measures at baseline and 
immediately after the 3 months of device use.   
  
Subjects: Between 12 and 20 participants with oropharyngeal swallowing problems will be recruited from the local 
area for participation. Participants must be 13 years of age or older. Parental consent will be obtained simultaneous to 
participant consent if the participant is under 18. Recently the principle investigator was contacted by the speech 
pathologist of a minor who has had a stroke and dysphagia and is interested in participating in this study. 
 
Recruitment: Participants will be recruited from community hospitals, rehabilitation centers, and home health 
services in the local area. Participants who have previously participated in the protocol, The Passy Muir Swallowing Self 
Training Device to Enhance Recovery Post Stroke (13-0010), and have documented during the consent process that they 
will wish to be contacted with information on future studies will also be recruited to participate in this study. 
 
Each participant will be given $20 for each visit they attend at Sentara RMH Medical Center (SRMH) for training or 
data collection purposes and $100 upon completion of the study. Travel mileage will also be reimbursed. All study 
compensation will be given in the form of a check mailed to the participant to the address they have specified by the 
study sponsor, Passy Muir. Hotel stay can be arranged and paid for if the participant is required to stay in Harrisonburg 
overnight. Hotel stay will also be paid for by the study sponsor, Passy Muir.  
 
Documentation of Dysphagia:  Participants will be identified as having swallowing difficulties for admittance into the 
study by obtaining medical records. Swallowing difficulty will be verified during the modified barium swallow completed 
as a baseline outcome measure.  
 
Exclusion criteria:  Exclusion from this study is contingent on participant self-report of one of the following:  
• 
Ongoing psychiatric disorder for which the patient is receiving medication and is under the care of a 
psychiatrist 
• 
Epileptic seizure 
• 
Severe speech or language problems affecting communication and reading comprehension 
• 
Cognitive impairment limiting understanding of the consent process and ability to follow directions as 
assessed by the Folstein Mini-mental State Examination (Folstein et al. 1975) with a score of less than 
23. 
• 
Diagnosis of esophageal disorders interfering with the ingestion of food and/or liquid. 
• 
Inability to tolerate a nasal endoscopic exam. 
• 
Rapidly progressive neurological disease such as amyotrophic lateral sclerosis, myasthenia gravis, and 
progressive supranuclear palsy.  
 
Inclusion criteria:  
• 
Participant must be 13 years old or older 
• 
If the participant is under 18, parental consent must be given 

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• 
Stable medical condition 
• 
Diagnosis of oropharyngeal dysphagia confirmed by MBS baseline measure of the follow two scales:   
o Penetration-Aspiration Scale score of 2 or greater verified by modified barium swallow 
(Rosenbek et al., 1996; Appendix I) and/or 
o Functional Oral Intake Scale  score of 5 or lower (Crary et al., 2005; Appendix P) 
• 
Folstein Mini-Mental State Examination (MMSE) score of 23 or greater indicating cognitive ability to 
follow directions and communicate preferences (Appendix H) 
• 
Willingness to travel SRMH2 or more times to undergo initial evaluation, device use training and 
checkup at 3 months.  
 
 
   
Exclusionary Criteria for Participants Who Agree to Undergo MRI and fNIRS: 
• 
Pregnancy 
• 
Cardiac problems  
o history of cardiac rhythm condition (including heart murmur or cardiac arrhythmia)  
o 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 MRI. 
• 
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 fNIRS probes will be placed on the scalp  
• 
Claustrophobia 
• 
Previous surgery that used surgical staples 
• 
Artificial joints 
 
Will data be collected from or about any of the following populations? 
 
X 
 Minors (under 18 years of age); Specify Age: 13 and over 
 
 
 Prisoners 
 
 
 Pregnant Women 
 
 
 Fetuses 
 
 
 Cognitively impaired persons 
 
 
X 
 Other protected or potentially vulnerable population 
 
 
 Not Applicable   
 
Passy-Muir Swallowing Self-Trainer 
 
The Self-Trainer is designed to be used in either automatic or manual mode. The mode can be easily set using a 
switch on the side of the controller. When the controller is in automatic mode, the device will vibrate up to 15 seconds 
every 3-5 minutes. These specifications are set by connecting the Self-Trainer to a computer terminal by the 
investigators. When the controller is in manual mode, the device operates in a momentary manner, specifically the 
device only vibrates when the button is pushed.  
 
Swallow Practice 

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The participant will practice swallowing with the Self-Trainer daily in their home environment for 3 months. The Self-
Trainer device will be set to vibrate at a vibration rate and pressure that is ideal for each participant based on testing 
(see Procedures Part B, section g). The participant will wear the Self-Trainer during waking hours with the device in 
automatic mode. In automatic mode the Self-Trainer will be programmed to vibrate up to 15 seconds every 3-5 minutes 
to stimulate saliva swallows and promote swallowing practice. In this manner the participant will complete 
approximately 180-300 saliva swallows per day.  
The participant will also engage in 30-60 minutes of active swallowing practice every day by switching the device to 
manual mode and manually pushing the button to turn on the vibration while swallowing, and releasing the button to 
turn off the vibration. The participant will complete a total of 60 practice swallows a day by doing 30 trials of practice 2 
times a day. Participants will be given a small 5 cc syringe or ¼  teaspoon for administering 1-2 cc of water (equivalent to 
a saliva swallow) to moisten their mouths during each of their practice swallows. 
 
 
Participant and Caregiver Instruction  
Each participant and their caregivers will be trained in the following:  1) Self-Trainer placement; 2) Self-Trainer 
charging and use; 3) Self-Trainer cleaning; and 4) Aspiration precautions.  Participants and caregivers will learn to locate 
the thyroid notch (Adam’s apple) and place the motor contacts so that they are on either side of the thyroid notch 
(Figure 1). Each participant’s device attachment cuff will be marked to illustrate where the Velcro should be secured to 
assure appropriate tightness for a neck pressure that is comfortable but effective for inducing swallowing during 
vibration. The participant and caregiver will also learn to verify correct placement by phonating while the vibration is on 
to determine if they can hear the sound of the vibration in their voice to indicate correct placement.   
 
The participant and caregiver will learn the differences between automatic and manual modes and how to change 
the device to operate in each mode.  Verbal, written, and/or video instructions will instruct the participant and caregiver 
to secure the Self-Trainer to the outside of the participant’s neck (as described above) every morning after breakfast 
with the device set in automatic mode.  The participant will wear the Self-Trainer set to automatic mode during waking 
hours with the exception of mealtimes, swallowing practice and during vigorous exercise when it may be cumbersome 
to use.  The participant will learn to correctly sequence active swallowing practice with the Self-Trainer, which involves 
the following steps: 1) pushing the button to turn on the device vibration, 2) initiate swallowing within a 1/3 of a second 
while the vibrator is “on”, and 3) releasing the button when the swallow is completed.  Participants will be given written, 
pictorial, and/or video instructions on how to use the device and how to verify correct placement of the device. 
Instruction and training will be provided on how to daily clean and charge the device.  Participants will learn to follow a 
daily regimen for preventing aspiration of secretions and for preventing aspiration pneumonia including good oral 
hygiene, monitoring for wet vocal quality, taking their body temperature, and only using the Self-Trainer in an upright 
position (see Human Subjects Protection).  
 
 
 
 
 
 
 
 
Dependent variables:  
Data on participant training:  Each participant and their caregiver will be asked to demonstrate device setting up and 
use after each training session.  When the participant and caregiver are able to demonstrate appropriate use based 
Figure 3. Time course 
Enroll 
Baseline measures 
Train device use 
Practice swallowing retraining with the device every day 
Stop use of self-trainer 
Assess outcome measures 
 
Phone call follow up 1x/month, 
Participant sent survey at 6 mo. 
End study 
Month 1 
Month 3 
Months 4-6 

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on a checklist completed by the examiner, their training will be completed.  The number of training sessions 
required and total training time before accurate use is demonstrated will be recorded for each participant. The 
participants will also be asked a series of multiple choice questions about the usefulness of training sessions and 
training materials.  
 
Outcome measures for documenting swallowing and dietary changes will be taken at baseline and at end of the 3 
month self-training period. Outcome measures for all participants will include the following: 1) Training and 
maintenance data; 2) Participant feedback questionnaire; 3) Participant fidelity data; 4) Modified Barium Swallow 
administered and scored with the Modified Barium Swallow Impairment Profile Protocol (Martin-Harris et al., 2008) 
and the 5) Dysphagia Outcome and Severity Scale (O’Neil et al., 1999) with the rater blinded to participant ID and 
condition; 6) the Dysphagia Handicap Index (DHI) (Silbergleit et al., 2012); and 7) percent change in hemoglobin 
oxygenation in the somatosensory and motor regions associated with swallowing and measured with functional 
near-infrared spectroscopy (fNIRS) as an indirect measure of brain activation changes.  
 
Procedures: 
A. Telephone screening done by speech pathologists in the Laboratory of Neural Bases of Communication and 
Swallowing 
a. Telephone screening script (Appendix A); if persons are not excluded at this point, they will be invited to 
continue enrollment with the informed consent process.  
b. Participants will be mailed records request to sign and mail to their hospital to obtain medical records 
for enrollment diagnostic verification. Diagnoses will be confirmed by medical records review before 
enrollment into the study.  
c. Participants will also be mailed the informed consent form for information purposes prior to the 
consenting visit  
B. Informed Consent (Appendix B) and Research Screeners: Consenting appointment can take place at James 
Madison University’s Laboratory of Neural Bases of Communication and Swallowing or SRMH Voice and 
Swallowing Service in the Outpatient Center. As all consent and release forms contain participant information 
(name), these will be stored separately from the de-identified case report forms in a locked cabinet at the James 
Madison University Neural Bases of Communication and Swallowing Lab. This lab remains locked at all times and 
allows only authorized keycard entry. Participants who are under 18 will be asked to sign an assent form, which 
describes the research procedures in grade appropriate language, and their parent/guardian will be asked to 
sign a parent consent form to allow their child to participate in the research.  
a. A medical history form will be used to gather background information on the participant’s medical 
history (Appendix C) 
b. Eligible participants will read or be read the risks and benefits with the investigators before signing the 
consent form. Each participant will be provided with a copy of his or her signed informed consent form.  
c. After signing consent forms, participants will be asked to sign release forms 
i. Release form: Participants have access to the summarized group data from this research 
(Appendix D) 
ii. Release form: Researchers may use their data for educational purposes (Appendix E) 
iii. Release form: Permission for Future Contact Release Form, Neural Bases of Communication and 
Swallowing Laboratory (Appendix F) 
iv. Release form: Permission for Future Contact Release Form, Communication Sciences and 
Disorders Department (Appendix G) 
d. Folstein Mini-Mental State Examination (MMSE) will be administered as a screening examination 
(Appendix H)  
e. Dysphagia Outcome and Severity Scale (DOSS) (O’Neil et al., 1999) will be administered as a screening 
examination and allows the speech pathologist to assign a 1 to 7 numerical score to the safest food and 
liquid consistency that the participant can take orally, ranging from no food restrictions to no oral 

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intake. As a screening test, the DOSS will be completed by the speech pathologist per discussion with 
the participant about their current oral intake (Appendix J). This rating scale form will be identified only 
by ID number with no personal health information.  Each participant must obtain a score of 5 or lower, 
indicating a restricted diet secondary to oropharyngeal dysphagia, to participate in the protocol.  
f. Consented subjects will fill out the Edinburgh Handedness Inventory (Appendix O), a 10 question survey, 
to determine hand dominance.  
g. Self-Trainer Motor Selection: If the participant has participated in the protocol “The Passy Muir 
Swallowing Self-Training Device to Enhance Recovery Post Stroke” (IRB 13-0010) then the optimal motor 
settings for the participant from this study will be used. However, if the participant has not participated 
in the previous study, then optimal motor settings will need to be identified for that patient. Motors at 
frequencies ranging from 30-150 Hz and other hybrid motors combining two frequencies (using 2-6 kPa 
neck pressure) will apply 8 seconds of stimulation followed by 15 seconds of rest for a total of 28 
stimulation trials for a total of 10.7 minutes per motor frequency. Using the same vibration time 
specifications, neck pressure, vibration mode, and vibration duration may also be tested so that optimal 
motor parameters can be selected for each participant. Online recordings of bi-axial accelerometry of 
laryngeal motion and inductive plethysmography of respiration will identify laryngeal movement and 
respiratory apnea to confirm swallows. The rate of swallowing during the 10.7 minute condition will be 
computed for each motor condition and compared to baseline to identify the optimal motor to use with 
the patient for daily swallowing self-training during device use. All testing done for motor selection will 
be video recorded for later analysis. Each digital video file will be saved using the participant’s study ID 
only and will be stored on an encrypted drive for 5 years after publication, after which it will be 
destroyed. 
i. Online digitizing with AD instruments Powerlab and Chart software will record accelerometry on 
the neck measuring laryngeal movement onset and offset and inductive plethysmography 
noninvasive recordings of chest wall and abdominal respiratory movement to identify swallows 
and the apneic period. These recordings will be identified only by ID number and stored as Chart 
files for analysis on encrypted computers or the secure server in the laboratory at JMU 
accessible by VPN from laptops in the Voice and Swallowing Service. Analyses will be conducted 
on workstations in the Laboratory of Neural Bases of Communication and Swallowing at JMU 
and only identified by ID code with no personal health information (PHI).  
C. Training session 
a. The participants will be trained on appropriate device placement, appropriate device pressure, how to 
verify correct placement of the device, and how to use the device daily for swallowing therapy. 
Caregivers will be encouraged to attend to provide support and will be trained to “coach” the 
participant.  
b. Self-Trainer guides will be given to the participant in the following forms:  
i. Written directions with pictures 
ii. Optional DVD instructional video 
c. Once the participant and their caregiver can demonstrate correct use of the Passy Muir Self Trainer for 
Swallowing, they will be given the device to take home and use for 3 months. The investigators will 
provide phone support to the participant and caregivers every day for the first 3 days of participation 
and on a weekly basis after that. The participants and caregivers will be encouraged to call the 
investigators with questions as needed and the investigators will be available for one on one meetings 
as needed. All contacts will be documented. 
 
D. Outcome measures 
Outcome measures a-e will be completed at the SRMH Voice and Swallowing Services in the Treatment 
Center. Voice and Swallowing Service is a collaboration between SRMH Healthcare and James Madison 
University.  

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a. Training and maintenance data will be taken on each participant and will include how many training 
sessions were required to demonstrate competency for device use, the duration of each training 
session, caregiver involvement, documentation of questions or comments during maintenance phone 
calls, and how many times the participant contacted the research team and for what purposes.  
b. Participant feedback will be gathered at the end of the 3 month self-training period.  The participant will 
read or be read a series of multiple choice questions (Appendix K) regarding their opinion on the training 
they received, ease of device use, and design of the device. The participants will be instructed to answer 
truthfully and will be assured that their answers will not impact their treatment or enrollment in this or 
future research studies at JMU/SRMH.  
c. Participant fidelity will be measured by 1) daily documentation by the participant or caregiver on device 
use and 2) downloading the count data from the device periodically throughout the study which 
provides data on how many times the device has vibrated in automatic mode and in manual mode.  
d. Modified Barium Swallow study (MBS) will be completed in radiology and requires the participant to 
swallow small amounts of barium.  This will be done by a licensed speech-language pathologist who has 
been trained to complete MBS. An MBS study will be completed at baseline and after the 3 month self-
training period. During each exam the participant will swallow thin liquid, nectar thick liquid, honey thick 
liquid, puree, and solid texture (cracker/cookie).  For the entire MBS protocol, see Appendix L. The 
participant will be given each consistency in gradually increasing amounts from 5 ml to approximately 15 
ml (See Human Subjects Protection).  If more than a trace amount of aspiration is observed on any trial, 
the remaining trials of that consistency will be discontinued from the study. Radiation exposure time for 
each study will be 5 minutes or less. All MBS studies will be recorded for later analysis.  All recordings 
will be de-identified with a random ID number. Each MBS study will include a 19 mm metal sphere 
calibration marker be taped to the side of the neck for future displacement measures. Each video will be 
analyzed for:  
 
 
i. Modified Barium Swallow Impairment Profile score (MBSImP) (Martin-Harris et al., 2008) allows 
the speech pathologist to rate specific physiological movement during each swallow and assign 
an overall 0 to 55 numerical score representative of swallowing impairment in the oral, 
pharyngeal, and esophageal phase (Appendix L). 
ii. Dysphagia Outcome and Severity Scale (DOSS) (O’Neil et al., 1999) allows the speech pathologist 
to assign a 1 to 7 numerical score to the safest food and liquid consistency that the participant 
can take orally, ranging from no food restrictions to no oral intake. The DOSS will be completed 
by the speech pathologist while reviewing each MBS while participant ID and condition will be 
masked (Appendix J). This rating scale form will be identified only by ID number with no 
personal health information.   
e. Dysphagia Handicap Index (DHI) (Silbergleit et al., 2012) survey requires the participant to rate their 
agreement with 25 statements pertaining to their swallowing (Appendix M).  The DHI is designed to 
determine how the patient’s swallowing affects their day to day quality of life on a physical, functional, 
and emotional level and possible scores range from 0-100. The DHI will be completed by the participant 
with help from the caregiver or speech pathologist as needed.  The DHI will be completed at baseline, 
after the 3 month self-training period, and at 1 month post the self-training period. This survey will be 
identified only by ID number with no personal health information.  
f. Magnetic Resonance Imaging:  Some participants may be scheduled to receive an MRI scan at SSRMH as 
a part of the study. The MRI image can be used to identify the 3 dimensional locations of particular 
regions of the brain from the scalp position and can also provide information as to the anatomical 
location of brain tissue damage, for example, if the patient has had a stroke or brain injury. MRI scans will 
be conducted at SRMH on a 1.5 Tesla MRI, to allow fNIRS recording from corresponding anatomy.   
 
Female participants who are pregnant cannot undergo a research MRI scan. Although there have not 
been any reports of injury to a fetus from MRI, we want to prevent any unforeseen difficulties when 
these scans are being performed for research purposes and are not needed for patient care. Female 

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participants who have child bearing potential will need to undergo pregnancy testing prior to MRI 
scanning. To decide whether a female participant has child bearing potential, we will also ask each 
female participant the date of their last menses in order to determine whether they are post-
menopausal.  Any female participant who is over 1 year since her last menses will be considered post-
menopausal (unless they are breastfeeding) and not have child bearing potential and will not require a 
pregnancy test. All  female participants who have child bearing potential (i.e. are not post-menopausal ) 
will be given a pregnancy test kit by the JMU research team (free of charge) and will be asked to take 
the pregnancy test the morning before going to the SRMH for their MRI scan. They must report to the 
research staff at JMU that the test was negative before going for their MRI scan. If participants have not 
reported a negative pregnancy test before a scan, the scan will be cancelled by the JMU staff by 
contacting the SRMH. Results of the pregnancy test will be confidential and discussed privately with the 
participant alone, even if the participant is a minor. Participation in the MRI will not be essential for 
participating in the study.  
g. Functional Near-Infrared Spectroscopy (fNIRS) will be conducted on those participants willing and able 
to travel to James Madison University Neural Bases of Communication and Swallowing Laboratory for 
testing prior to device use and after 3 months of device use. Therefore, fNIRS data may not be taken on 
every participant.  fNIRS will be used to measure the hemodynamic response in the brain while the 
participant is asked to actively swallow, recording cortical activation changes in the primary motor 
cortex and   somatosensory cortex bilaterally during swallowing in comparison with rest. Participation in 
the fNIRS will not be essential for participating in the study.  
i. This is a noninvasive technology using optodes to emit laser lights, similar to pulse oximetry in 
concept and practice. Light detectors are placed 3 centimeters from the emitters to absorb any 
reflected light from the emitter. These emitters and detectors are placed on the scalp after 
parting the hair to reduce inference from pigment in hair. The only risk to participants and the 
investigative team is if the emitters are turned on and a laser light could be shined in someone’s 
eyes, similar to laser pointers. Therefore, the emitters will only be turned on after they are 
placed and attached to a participants scalp. The lasers will be turned off prior to moving or 
replacing the emitters on the scalp.  Six emitters and ten detectors will be attached to the scalp 
over 6 locations with Coban material, a self-adhesive stretching material similar to an Ace 
bandage, which will be wrapped over the optodes and detectors to keep them in place. Bobby 
pins and clips will be used to part the hair when appropriate, a non-invasive procedure. No hair 
will be cut and any color markings made on the scalp for the Brainsight identified coordinates 
will wash off in the shower with shampoo.  
ii. fNIRS data files will be deidentified and saved for later analysis. fNIRS sessions will be video 
recorded and saved for future analysis. Each digital video file will be saved using the 
participant’s study ID only and will be stored on an encrypted drive for 5 years after publication, 
after which it will be destroyed.  
 
E. Participants will return to the SRMH Voice and Swallowing Service at the end of the 3 month self-training period 
to document outcome measures as outlined in section C. If the participant has also opted to participate in fNIRS, 
they will also return to the James Madison University Neural Bases of Communication and Swallowing 
Laboratory at 3 months.  
F. Follow up and Discharge:  
a. During months 4-6 the investigators will contact the participant by phone or Skype one time each month 
to follow up on their progress and answer any questions. At the end of month 6, the participant will be 
mailed the Dysphagia Handicap Index survey (Appendix M) to complete and return by mail and a 
statement of discharge from the study (Appendix N). The participant will be encouraged to contact the 
investigators if they should have questions or concerns in the future.  
 

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Potential Problems and Alternative Strategies:  Anticipated problems include difficulties with recruiting an adequate 
sample of patients in the Harrisonburg area for testing in our clinic at SRMH. A website has been developed for 
promoting research on the swallowing Self-Trainer (swallowingselftrainer.com), which can be used by the public, speech 
pathologists or participants, to educate themselves on the uses of the Self-Trainer or to get contact information. 
Advertisements on Google and on the National Foundation of Swallowing Disorders are also in place to help with 
recruitment.  In this manner, participants who are interested in swallowing research can self-refer. Also participants who 
have participated in a previous protocol involving the Self-Trainer and have stated that they give permission for future 
contact will be contacted for participation in this study.  Participants can also be recruited from the SRMH/JMU Voice 
and Swallowing Service, the SRMH/JMU Swallowing Support Group, which meets bimonthly as well as other dysphagia 
services in the area, including other local support groups. Local speech-language pathologists will be informed of current 
research projects and will be able to inform their patients to contact us for more information.  
 
Statistical Analysis: Questionnaire data will be categorized and coded. Quantitative data will be analyzed using 
Analysis of Variance (MANOVA) for repeated measures with a Bonferroni corrected alpha of 0.05.  
 
Human Subjects Protection  
A. Potential Risks 
During this case series, the participants are asked to wear the swallowing Self-Trainer around their neck 
to provide vibratory stimulation to the nerves that influence swallowing. They will wear the device during 
waking hours and prior research has shown that the stimuli can increase the frequency of swallowing 2-3x 
their normal rate. Participants will be instructed to only take food or liquid consistencies by mouth for 
nutritional purposes as recommended by the SLP based on their modified barium swallow while the device 
is on for swallowing training. Rather, the participants will swallow their own saliva or an equivalent amount 
of water (1-2 ml) as a part of the self-training, as they do on a normal basis throughout the day.  As the most 
persons use up their saliva after 3 swallows, participants will be given a small syringe or  ¼ teaspoon for 
administering 1-2 ml of water, equivalent to a saliva swallow, to moisten their mouths while practicing. 
For participants who take food orally these consistencies must be approved by the SLP as being safe to 
use with the device.  If the participant is not safe for any intake, instructions will be given to remove the 
device from the participant’s neck prior to food consumption they take for pleasure.  As the Self-Trainer is 
known to increase the frequency of swallowing, the participants will be swallowing their secretions more 
frequently and therefore it is possible that each participant’s risk of aspirating could change.  For some 
participants, specifically those who do not swallow their secretions and instead periodically expectorate, the 
participant is now attempting to swallow the secretions instead of attempting to clear them form their 
oropharynx using regurgitation.  Participants who do not feel secretions pooling in their throat may have a 
decreased risk of aspirating secretions while using the device as they are now prompted to swallow.  As 
saliva swallows and the risks associated with saliva aspiration are an ongoing daily risk for these participants, 
this study provides only a minimal increase in risk. Efforts will be made to minimize any risk associated with 
participation in this study (see Protection against risks). If a participant expectorates their saliva as a part of 
reducing aspiration risk, they will be encouraged to continue with this practice as needed, but to try to 
swallow when they feel the urge to swallow as part of the self-training. The study will be conducted by a 
licensed speech language pathologist who will counsel each participant on minimizing secretion aspiration 
risk. 
 
Participants will be encouraged to continue with their current swallowing treatment plan of care as 
determined by their speech language pathologist. We will take great care to make certain that all 
participants and their family and caregivers do not misinterpret the purpose of this research and fully 
understand that this study is experimental research with no guarantees of benefit.  It will be made clear in 
the advertising material, informed consent and in any discussions with the participants and family members 
that treatment received is experimental research and there is no guarantee of improvements in swallowing 
function.  The speech language pathologist conducting the research will provide participants and their 

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caregivers with referrals to patient services in their area for treatment of their swallowing disorder if 
appropriate.  
 
During the Modified Barium Swallow study the participant will be exposed to small amounts of 
radiation. As we are testing a minimum of 2 and a maximum of 12 swallows for each test, it is expected that 
the amount of radiation the participant will be exposed to will be negligible.  
 
MRI does not involve  radiation and is safe when used on individuals who are appropriately screened for 
the procedure.  The FDA has classified MRI as a class II risk.  Individuals with any implanted metal objects in 
the brain or body are at risk of injury with MRI procedures due to the high magnetic force to which they are 
exposed.  Therefore, individuals with one or more of the MRI exclusion criteria will be excluded from the 
study.  The principal investigator will review each of the exclusion criteria with the participant. Acoustic 
noise is generated in the magnet when the gradient coils are energized and de-energized in the magnetic 
fields to create MRI images.  Subjects will be required to wear earplugs during the scan, which will be placed 
by the investigators. No incident of hearing impairment has been reported before in clinical scanners.  
During the scan, the investigator will monitor the patient’s comfort level.  We consider that the procedures 
described above are safe and should not produce any undue discomfort for subjects.  The main discomfort 
associated with the study is the need for the subject to remain quiet within the scanner for the duration of 
testing, about 20 minutes maximum.   
 
 
B. Human Subjects Protection- Recruitment and Informed Consent 
Participants will be recruited through community hospitals, rehabilitations, and home health services. 
We will recruit from area speech language therapy service centers by placing advertisements in the waiting 
areas and asking professionals including neurologists, otolaryngologists, and speech-language pathologists 
to place notices in their waiting and office areas. Notices will also be mailed to professional involved in 
rehabilitation in the Shenandoah Valley area asking them to place notices in their waiting and office areas. 
We will also be using email blasts, discussion board postings, and a website (swallowselftrainer.com) to 
increase awareness of the study among speech language pathologists and patients with swallowing 
disorders in the community. We will only ask professionals to place notices and make literature available on 
our study but not to refer patients directly to us so patients will not feel under any undue influence from 
their professional caregivers to participate. Our notices and literature will provide information that will allow 
participants to contact us directly and the website will allow patients to self-refer.   
We have 3 rooms in the JMU-SRMH Voice and Swallowing Service to support multiple participants being 
tested simultaneously. Free parking is immediately available within 100 ft of the entrance to our testing 
grooms in the Treatment Center on the ground floor of SRMH.  The burden to participants will be the daily 
use of the Self-Trainer for 3 months, the majority of which the device will be switched in “automatic” mode 
requiring no active engagement on the part of the participant. Active practice required of the participant 
consists of 60 swallows and will take from 30-60 minutes a day.  Additional burden to the participant 
includes 3 or more visits to SRMH for testing measures, while periodic counts taken from the Self-Trainer 
can be completed with laptops and can be done in the participant’s home, JMU or SRMH as is convenient.  
Weekly check ins can be done over the telephone, Skype, or as needed by the participant to answer 
questions and verify compliancy, although in person appointments can be made if needed.  
Administration of informed consent: Participants will be telephone screened and if they meet the 
inclusion criteria, they will be mailed the consent form for information purposes to allow them to review it 
before coming to the Voice and Swallowing Service. The consent will inform participants that Dr. Ludlow has 
a financial interest in the research. Either Dr. Ludlow or Dr. Kamarunas, the speech language pathologist, will 
administer informed consent to the participant. During the consent process, either Dr. Ludlow or Dr. 
Kamarunas will review the study with the participant and any family members present to answer questions. 
The participant will then read or be read the consent and answer a few questions to demonstrate they have 

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understood. The consent will then be signed, witnessed, and a copy given to the participant. Participants 
who have sight or literacy problems will have the consent read to them and a series of questions will be 
asked of all participants to assure their comprehension of the study before completing the informed consent 
process. No proxy consent or assent will be accepted for this study.  
 
C. Protection against risk 
As listed above under Potential Risks, this application is expected to involve only minimal increased risk 
from the research procedures for participants with swallow disorders as only saliva swallows or 1-2 ml water 
swallows as needed (equivalent to a saliva swallow) will be used while the device is on. All participants will 
be producing saliva normally and will be exposed to the risk of saliva aspiration throughout the day in their 
normal living. This risk occurs even when they are receiving enteral feeding either through a PEG tube or 
nasogastric tube. With the increased frequency in swallowing associated with the Self-Trainer, there is a 
minimal increased risk for the participant because of their swallowing disorder.  
To minimize the risk associated with saliva aspiration, the speech language pathologist conducting the 
research will train all participants and their caregivers on a daily regimen to follow for secretion aspiration 
prevention and an oral hygiene regime to reduce oral bacteria. Each participant and their caregivers will be 
trained to competency on the following aspiration monitoring methods: 
1. Oral hygiene including cleaning the mouth, teeth (or dentures), tongue, etc. with toothpaste and 
mouthwash, as deemed appropriate, after meals or 3 times a day.  
2.  Voice quality testing to detect a wet, gurgly voice quality which would indicate increased fluid in or 
around the airway.  If voice quality sounds “wet” they will be trained to voluntarily move secretions 
away from the airway by throat clearing/coughing to bring the secretions in the mouth and then 
spitting or swallowing the materials brought up.  
3. Daily body temperature monitoring: The participant and their caregivers will be instructed to 
contact the research staff if they have a rise in body temperature over three days sequentially while 
participating in the study.  
4. Participants and caregivers will be instructed to only use the Self-Trainer while sitting in an upright 
position, which may be helpful in preventing the aspiration of oral secretions. If the participant 
needs to lay down for any reason, the Self-Trainer should be switched off and/or removed from the 
participant’s neck.  They will also be instructed not to use the self-trainer during vigorous exercise 
(like running) as this would be cumbersome and could result in damage to the device.  
5. Participants will be instructed not to use the device with any oral intake they are unsafe for. The SLP 
will make recommendations as to what food consistencies the participant is safe for consuming 
while using the device. If they are unsafe on all consistencies, the recommendation will be not to 
wear the device while there is any food in their mouth.  
D. Adverse events 
Participants will be monitored for the occurrence of adverse events throughout their enrollment in the 
clinical study.  All adverse events occurring during the course of the clinical study, whether device-
related or otherwise, will be recorded on the Adverse Event CRF. Records of adverse events (AE) will be 
evaluated by the medical officer, Dr. Kini, the Study Team and the JMU and SRMH IRBs for participants 
in the protocol.  Serious adverse events (SAE) will be evaluated by Dr. Kini and reported to the IRBs at 
JMU and SRMH within 10 days of their occurrence.  The study physician will assess and report on the 
relationship of the adverse event to the investigational device as well as the severity of the event, the 
outcome of the event, and whether or not the adverse event could have been anticipated.  The IRBs will 
evaluate the reports of AEs/SAEs to determine if use of the device shows increased risk of aspiration 
pneumonia and other problems indicating that use of the device produces “more than minimal“ risk.   
 
 
 
 
Data Analysis 

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Data integrity will be assured by using the LabTrack electronic notebook system in Dr. Ludlow’s lab which is on a secure 
backup server. This system meets FDA standards for data monitoring. Case Report Forms (CRF) will be setup with 
templates requiring entry of all essential data elements on each participant such as inclusion/exclusion criteria, consent 
records and records of visits, telephone contacts, and correspondence tracking each participant’s involvement in the 
research.  The LabTrack system tracks all entries, the date and the identity and any data changes by user ID.  All measures 
will be entered into data files on the Laboratory server by participant ID number. All videos associated with the study will 
be stored on encrypted drives for at least 5 years. The PI and speech pathologist will conduct monthly quality assurance 
reviews of the CRFs and data files. 
 
 
 
The outcome measure data points will include training and maintenance data, participant feedback survey, fidelity 
data, MBSImP score, Dysphagia Outcome and Severity Scale score, Dysphagia Handicap Index score, and fNIRS data 
(optional) at baseline and at 3 months. Each of these data points will be entered into data files by participant number in 
LabTrack and Excel.   
 
 
 
Paper case report forms will not contain any identifying information and will be stored in a locked cabinet at the James 
Madison University Neural Bases of Communication and Swallowing Laboratory, which requires authorized badge access. 
All deidentified data will also be recorded in the case report form on encrypted Laptops connected by VPN to the LabTrack 
system on a server in Dr. Ludlow’s laboratory. Participants’ status at the end of each test session will be recorded in the 
CRF in LabTrack.  
 
Reporting Procedures 
Result of this research study will be published in a professional peer reviewed journal intended for professionals 
who perform research in the field of dysphagia and/or work with individuals who have dysphagia. Participants will be 
given the opportunity to opt to have the research results in the form of the journal article sent to them by mail or email.  
 
 
Experience of the Researcher (and advisor, if student): 
 
Dr. Ludlow has conducted clinical research for over 35 years.  
 
 
 
 
Dr. Kamarunas successfully defended her dissertation in August of 2012. She is an author on two publications and 
has presented numerous times at national conferences.  
 
 
Seng Mun Wong, is a doctoral student in Communication Sciences and Disorders at James Madison University.  She 
has completed a Bachelor of Science degree in speech sciences from University College London in the UK.  Her research 
experience includes 2 co-authored publications in her previous employment at the Singapore General Hospital.  
 
 
Erin Staudt is a 1st year graduate student in the CSD department at JMU. Her involvement in this research project 
will include telephone and medical records screening, assisting in data collection, data analysis, and maintaining records.   
 
Additional Attachments as applicable: 
The following appendices are attached: 
Appendix A -  
Telephone Screening 
Appendix B -  
Consent to Participate 
Appendix C -  
Medical History Form 
Appendix D -      Release for Participant to Obtain Research Information 
Appendix E -  
Release of Data for Educational Purposes 
Appendix F -  
Permission for Future Contact Release Form, Neural Bases of Communication and Swallowing 
Laboratory 
Appendix G -  
Permission for Future Contact Release Form, Communication Sciences and Disorders Department 
Appendix H -  
Folstein Mini-Mental State Examination (MMSE) 
Appendix I -  
Penetration-Aspiration Scale 

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Appendix J-  
Dysphagia Outcome and Severity Scale  
Appendix K-  
Participant Survey 
Appendix L-  
MBSImP Protocol and Scoring (Martin-Harris et al., 2008) 
Appendix M-  
Dysphagia Handicap Index 
Appendix N-  
Discharge letter 
Appendix O-  
Edinburgh Handedness Inventory 
 
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