Clinical trial NCT03122145
Conditions: Healthy
Keywords: healthy volunteer
Sponsor: University of Florida
Start date: 2017-05-23; Completion date: 2019-02-28
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

Detailed description:
The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options and minimal management strategies offered to treat these individuals and improve sequelae of dysphagia. Dysphagia contributes to malnutrition, aspiration, pneumonia, reduced quality of life and increased mortality in neurodegenerative disease such as ALS. One reason for this is the lack of normative data across various measures of swallowing and respiratory function. As a result, detecting early impairments in swallowing physiology is difficult, given the variability of swallowing and unknown normative value range of swallowing physiology. Therefore, the goal of this study is to complete clinical tests of swallowing and cough function in healthy volunteers to establish normative data. This will contribute to future study in disordered populations, to determine degree and severity of impairment and efficacious treatment and management strategies based on impairment.

The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.

Arms: arm 1: This study will involve a single 60-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination. arm 2: This study will involve a single 60-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo a instrumental swallowing evaluation (videofluoroscopy). The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.
Interventions: intervention 1: Capsaicin intervention 2: Videofluoroscopic swallow study
Intervention descriptions: intervention 1: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in 80% physiological saline, 20% ethanol. Participants will inhale single vital capacity breaths of capsaicin solution via an air-powered dosimeter (KoKoDigidoser; Pulmonary Data Services Instrumentation Inc; Louisville, CO). The reflex cough test ends when the participant coughs at least 2 times in response to one inhalation dose, or receives a dose of the highest concentration (500 μM). intervention 2: The swallowing systems core laboratory is fully equipped to perform videofluoroscopy with a c-arm (OEC 9900) that is dedicated solely to research purposes. Videofluoroscopy recordings will be kept to a minimum and turned on only during completion of a specific testing task. Video recording and images captured during the videofluoroscopy will be synced and saved for data analysis. Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks. The physiological swallowing measures (temporal and kinematic of the base of tongue, oropharynx, and hyolarynx complex during swallowing) to be analyzed cannot be visualized with any other technique. All swallowing tasks will be completed using barium in order to visualize the bolus during movement of various swallowing muscles and structures.

Protocol documents:
Prot_ICF_000.pdf: 
Title: Establishing Normal Swallowing and Breathing Profiles in Healthy adults across the age span  
NCT: 03122145 
Date: January 31, 2019  
 


Establishing Normal Swallowing and Breathing Profiles in Healthy adults across 
the age span 
Key Personnel: 
Principal Investigator: Emily Plowman, PhD, CCC-SLP; (352-273-9215)  
Co-Investigators: Ianessa Humbert, PhD, CCC-SLP  
Other research staff:  Lauren Tabor, MS, CCC-SLP (study coordinator, 443-536-
1234)Raele Robison, MS; Andrea Siluk, BS; Rachel O’Neal, BS; Alycia Rivet, BS;  
Alessandra Gallastegei, BS, Alayna Ernster, Alicia Vose, CCC-SLP, Karen Hegland, 
CCCSLP, PhD, Julia Mikaela Apostol 
 
Background and Significance 
The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age 
(Howden, 2004).  There are few therapeutic options and minimal management 
strategies offered to treat these individuals and improve sequelae of dysphagia.  
Dysphagia contributes to malnutrition, aspiration, pneumonia, reduced quality of life and 
increased mortality in neurodegenerative disease such as ALS (Tabor et al 2016, Chen, 
2005; Burkhead, 2014).  One reason for this is the lack of normative data across various 
measures of swallowing and respiratory function.  As a result, detecting early 
impairments in swallowing physiology is difficult, given the variability of swallowing and 
unknown normative value range of swallowing physiology.  Therefore, the goal of this 
study is to complete clinical tests of swallowing and cough function in healthy volunteers 
to establish normative data.  This will contribute to future study in disordered 
populations, to determine degree and severity of impairment and efficacious treatment 
and management strategies based on impairment. 
Purpose: The purpose of this study is to establish normative values for clinical testing 
measures of swallow, respiratory and cough functions.  This will aide in establishing 
degree of impairment in disordered populations, and in identifying efficacious treatment 
paradigms for dysphagia.   
Study Setting 
Swallowing Systems Core Laboratory in Shands Hospital at the University of Florida 
(DG 130, 136, DG 76 and DG 77). 
Population and Sampling Data 
Participants will include up to 120 adults, both males and females across the lifespan. 
The primary goal of the proposed study is to establish normative data for comparison 


with disordered dysphagic populations in an age and gender matched fashion.  This 
study represents a pilot study and the work proposed and comparisons planned have 
not yet been performed in the dysphagic population using clinical testing 
measurements.  Given that some volunteers may not be able to complete all required 
tasks and lead to missing data we will recruit and run 20% additional then our target 
number of 100 for a total of 120 participants.  drop and some data may not be included, 
we plan to study approximately 100 participants. A power analysis is not included in the 
protocol as we are conducting the first study to collect normative data and establish a 
database of ‘normal’ functioning across various swallow and respiratory parameters.   
Inclusion/Exclusion Criteria. 
A total of 120 individuals will be included in this study. Subjects will include both male 
and females who are aged between 18-100, healthy and with no major medical 
conditions.  Adults who are pregnant, or those with major medical conditions (i.e., 
swallowing impairment, brain injury) will be excluded from this study. Anyone with 
allergy to barium will be excluded from this study.  No specific gender or race will be 
excluded or targeted for participation in this study.   
Recruitment Plan and Consenting Process 
Potential participants will be identified through word of mouth, Health Street and 
advertising via approved flyers within the University of Florida campus and surrounding 
areas of Gainesville.  We will also post approved flyers advertising participation in the 
study.  Interested volunteers will be given an informed consent and given ample time to 
read over this and ask any questions and given the option to take home informational 
material to determine if they would like to participate. Prior to consenting, all participants 
will be screened to determine eligibility for the study. To determine if you are eligible for 
the study, who are considered to be of childbearing age (less then 60 years) will be 
asked to complete a pregnancy test to confirm they are not pregnant prior to performing 
the exam. If a person consents to be in the study, they will sign the ICF document and 
provided with a hard copy of the consent material.  Study personnel will arrange a 
single, one-hour appointment time to perform the study.  No costs will occur for being in 
this study. Each participant will receive a parking voucher, as needed, for participating 
in the study and a $50 compensation will be provided to each volunteer to cover any expenses 
associated with attendance 
Protocol: 
This study will involve a single 90-minute visit. All women under the age of 62 will be 
asked to complete a pregnancy test as part of the screening process during to radiation 


exposure.  Eligible participants will then undergo testing to determine their individualized 
Maximum Expiratory Pressure (MEP), maximum inspiratory pressures (MIP), voluntary 
and reflexive cough testing, tongue pressure testing and  a comprehensive instrumental 
swallowing evaluation (that will include either videofluoroscopy, manometry, or 
simultaneous swallowing and manometry study). The entire duration of the exam will be 
under 90 minutes and the participant will be free to leave at any point during the 
examination.  
Procedures:  
Respiratory Testing: 
The participants’ maximum expiratory/inspiratory pressure (MEP/MIP) will be assessed 
using a hand-held digital manometer (MP01, Micro Direct Inc.). The subject will be 
standing and while wearing a nose clip be asked to blow out as hard and fast (MEP) or 
in as hard as they can (MIP). Forced vital capacity (FVC), a maximum effort breathing 
test assessing maximum volume exhaled, will also be completed. These tests will be 
completed a maximum of three times to obtain values within close range of one another. 
Subjects will also complete maximum effort cough testing, both voluntary and reflexive 
testing using a spirometry and pneumotachograph setup (Lab Chart Version 7). 
Videofluoroscopy and Barium: 
The swallowing systems core laboratory is fully equipped to perform videofluoroscopy 
with a c-arm (OEC 9900) that is dedicated solely to research purposes. 
Videofluoroscopy recordings will be kept to a minimum and turned on only during 
completion of a specific testing task.  Video recording and images captured during the 
videofluoroscopy will be synced and saved for data analysis. Videofluoroscopy allows 
for time-synced, frame-by-frame data analysis for the specific measures taken during 
swallowing tasks.  The physiological swallowing measures (temporal and kinematic 
movement of the base of tongue and hyolaryngeal complex during swallowing) to be 
analyzed cannot be visualized with any other technique.  All swallowing tasks will be 
completed using barium in order to visualize the bolus during movement of various 
swallowing muscles and structures. A standardized barium protocol will be administered 
that will include thin liquid, nectar thick liquid, honey thick liquid, pudding and a solid 
cracker.  We do not expect aspiration (bolus into trachea) to occur during this study 
given we are recruiting individuals with no prior history of disease or disorder, and 
aspiration is uncommon is normal swallowing individuals. Swallowing tasks during 
videofluoroscopy will consist of comfortable size cup sips/bites in various head positions 
(i.e., head turned, chin tucked down).  In addition to swallowing trials , the participant 
may be asked to perform a list of commonly utilized swallowing therapeutic maneuvers 


that will include: a chin tuck, a head turn to the left and right, a tongue press 
maneuverer and a breathing maneuver to allow quantification of the physiologic impact 
of these tasks on the upper aerodigestive tract in healthy adults.  These tasks will also 
be utilized during the High Resolution Manometry procedure, explained below.  
High Resolution Manometry:  
During the manometry portion of the evaluation, we will be using a small pressure tube 
that gets inserted into the nose and travels down to the back part of the throat. After the 
tube is in place in the throat, the subject will sit comfortably for five minutes to acclimate 
to the tube being in this position. After this time, they will be asked to swallow several 
teaspoon-sizes of a saline solution. Saline is a thin-water like solution that has a slightly 
salty taste. They may feel a slight discomfort as the tube is being placed in position and 
as they begin to swallow the saline with the tube in place. Time to complete all 
swallowing-related tests will be approximately 30 minutes and participation in this study 
will require only one visit.  Individuals have the option to decline this procedure if 
uncomfortable or difficult to tolerate. 
Tongue Pressure Examination:  
During the tongue examination, we will measure tongue strength and the maximum 
amount of time that the subject can apply pressure to an air-filled tongue bulb that will 
rest on the roof of your mouth. Lingual function will be evaluated using the Iowa Oral 
Pressure Instrument (IOPI). The Iowa Oral Pressure Instrument (IOPI) model 2.3 is a 
device that measures the peak pressure performance of lingual strength and endurance 
via the action of a bulb placed on the hard palate. The patient elevates the tongue to 
touch the roof of the mouth and pushes against the bulb. To assess maximum anterior 
isometric pressure, the bulb will be placed on the roof of the mouth and the participant 
will raise his or her tongue to apply pressure to this bulb and then quickly release the 
tongue back into a neutral position.  
Tongue Function Testing:  
We will also perform a technique called electrical impedance myography (EIM) of the 
tongue. EIM allows us to learn more about the health of the composition of the tongue 
muscle. We will gently rest a small tongue depressor containing a special sensing 
electrodes on the top of the tongue. We will then have the subject close their mouth for 
two seconds while the electrode obtains information about the composition of your 
tongue. They will not feel anything while the tongue depressor is resting on your tongue.   
Cough 


Voluntary Cough Testing: 
Voluntary cough function will be assessed using an oral pneumotachograph (MLT 1000, 
ADInstruments, Inc; Colorado Springs, CO), connected to a spirometer filter (MQ 304 
Spirometer Filter, Vacumed; Ventura, CA) during voluntary cough production. The 
participant will be seated with a respiratory facemask held in place by the examiner and 
instructed to complete three tidal breaths into the facemask, take a deep breath in and 
then “cough hard like you have something stuck in your throat”. This task will be 
modeled to the patient by the examiner and practiced first to ensure the patient 
understands the procedure. Airflow signal will be measured, low pass filtered at 150Hz, 
digitized at 1 KHz and displayed on a portable laptop computer using Chart Version 7 
(Microsoft Corp; Redmond, WA). 
Reflexive Cough Testing: 
Participants will be outfitted with a facemask covering the nose and mouth.  The 
facemask will be coupled to a pneumotachograph, differential pressure transducer, and 
have a side port with a one-way inspiratory valve for nebulizer connection.  The 
nebulizer will be a DeVilbuss T-piece connected to a dosimeter that delivers aerosolized 
solution during inspiration with a delivery duration of 2 seconds. The cough airflow 
signal will be digitized (Power Lab Data Acquisition System) and recorded (LabChart 7; 
ADInstruments, Inc) to a computer for offline analysis.  Participants will be seated for an 
initial 30 seconds of quiet breathing in order to acclimate to the facemask.  Participants 
will then complete a capsaicin challenge with three randomized blocks of 0, 50, 100, 
200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution 
consisting of 80% physiological saline, and 20% ethanol. Participants will be given the 
instruction “cough if you need to” prior to capsaicin delivery.  The solution will be 
administered automatically upon detection of an inspired breath and there will be a 
minimum of one minute between each trial. After each inhalation of the capsaicin 
solution, participants will be asked to rate their urge-to-cough (UtC) on a modified Borg 
scale, ranging from 0 (no urge to cough) to 10 (maximal urge to cough).  Participants 
will be provided water to drink between trials.  Members of our research team have 
extensive experience using this methodology for the induction of reflex cough (Hegland 
et al., 2012; Wheeler-Hegland et al., 2014), and we have a FDA IND # 76866 for the 
use of capsaicin in the study of cough reflex sensitivity and motor pattern. 
Data Collection Procedures 
The principal investigator will be responsible for safety and monitoring data (oversight 
plan).  The data will be collected and recorded by the principal investigator and her 
research assistants who will enter data into the research database. Data will be kept in 


a locked cabinet within a locked laboratory.  All data entered into the database will be 
coded to remove participant identifiers and this database is backed up daily. Data 
accuracy will be verified by double data entry. That is, following initial data entry the 
research assistant and /or principal investigator will verify the data entered into the 
database. Data verification will take place prior to any analysis of these data. Data, 
adverse events and individuals subject safety will be routinely monitored throughout 
each subject evaluation by the PI. A regulatory binder will be kept, in accordance with 
the IRB-01 Researcher Tools.  Any adverse event will be immediately reported to the 
IRB (using Regulatory Serious and Adverse Unexpected Event Form).  Early closure of 
the study may occur if the team is unable to enroll subjects, or subsequent to 
unexpected adverse events.  However, neither of the events are anticipated.  
Risks/Benefits Analysis 
• 
This research study involves exposure to radiation from x-rays. The radiation 
exposure you will receive from the swallowing test (videofluoroscopy) is about 50 
millirem. This radiation exposure is equivalent to 60 days of natural background 
radiation to which people in the United States receive each year. The risk from this 
radiation exposure is considered to be minor when compared with other everyday 
risks. However, the effects of radiation add up over your lifetime. Repeated exposures 
may increase your risk of injury or disease. When deciding to enter this study you 
should consider previous and future potential exposures. Examples would include x-
rays taken for a broken bone or radiation therapy treatments for cancer. The 
investigator will provide you with a contact person if you would like more information 
about radiation exposure. 
• 
The risk from this radiation exposure is considered to be minor when compared with 
other everyday risks.  However, the effects of radiation add up over your lifetime.  
Repeated exposures may increase your risk of injury or disease.  When deciding to 
enter this study you should consider previous and future potential exposures. 
Examples would include x-rays taken for a broken bone or radiation therapy 
treatments for cancer.  The investigator will provide you with a contact person if you 
would like more information about radiation exposure. 
• 
Barium will be the material used to help us see your swallow function and 
sometimes when testing is done the barium may enter your lungs during swallowing 
causing you to cough or feel some discomfort. While small amounts of barium 
ingested into the lungs does not pose a significant health risk, large amounts 
ingested over several days can lead to aspiration pneumonia, which is a bad 
respiratory infection. Therefore, we will stop the test if we see barium enter the 
airway on more than two swallows of liquid or food to prevent major health risk.  
• 
The ‘hot pepper’ vapor we will use to make you cough during this part of the testing 
contains capsaicin, which comes from hot peppers.  It may cause a hot sensation in 
your mouth and throat.  This will go away within a few seconds after you stop 
inhaling breathing the capsaicin vapor.   Water will be available to you whenever you 
want it.   


• 
Although not common, it is possible that you will experience jaw and throat muscle 
soreness after you are done completing the tongue strength and endurance trials. 
This discomfort should be temporary and subside within 48 hours. 
 
Outcome Measures: 
This study has several outcome measures because the goal is to establish normative 
parameters for a variety of clinical tests.  The outcome measures include: maximum 
expiratory/inspiratory pressures (MEP/MIP), which will be assessed using a hand held 
digital manometer (Micro Mouth Pressure Meter, MP01, Micro Direct Inc.). In order to 
measure MEP, the participant will be seated with the nose occluded with a nose clip. 
After inhaling to total lung capacity, the participant will place his or her lips around a 
disposable mouthpiece and blow out as forcefully as possible. Numbers are then 
recorded with the maximum across all three trials used for data analysis purposes. 
Additional outcome measures include maximum effort results from: high resolution 
manometry (pressure recordings), swallowing timing and kinematics (swallow study) 
and tongue pressure recordings (tongue testing).  The procedures of these tests are 
described above.  
Data Analysis 
Data analysis will be primarily descriptive, including central tendency, range and 
standard deviation in order to determine average values for each of the completed tests. 
This will help to create the database for normative parameters for swallowing and 
respiratory tasks.    
Limitations 
It is possible that there may be a limitation in the age range of the sample size, as we 
are recruiting from a university setting.  There are no other known limitations to the 
present study. 
Implications 
This study will provide researchers and clinicians with the data to compare disordered 
populations with normative parameters across clinical testing procedures.  The results 
will contribute to evidence for identifying disorder and subsequently recommending 
certain swallowing therapy approaches.  
None of the study members on this team have a financial interest or conflict of interest. 


References 
Howden, C.W. (2004). Management of acid-related disorders in patients with dysphagia. American 
Journal of Medicine, 117 (5A): 44S-48S. 
Chen, A, Garrett CG (2005) Otolaryngologic presentations of amyotrophic lateral sclerosis. 
Otolaryngology--Head and Neck Surgery 132 (3):500-504 
Tabor, LC Gaziano J, Watts S, Robison R, Plowman EK (2016) Defining Swallowing-Related Quality of 
Life Profiles in Individuals with Amyotrophic Lateral Sclerosis. Dysphagia. doi:10.1007/s00455-015-9686-
2 
Wheeler Hegland K, Troche MS, Brandimore AE, Davenport PW, Okun MS (2014) Comparison of 
voluntary and reflex cough effectiveness in Parkinson's disease. Parkinsonism & related disorders 20 
(11):1226-1230. doi:10.1016/j.parkreldis.2014.09.010 
 
Hegland KW, Bolser DC, Davenport PW (2012) Volitional control of reflex cough. Journal of Applied 
Physiology 
 
 
 
 


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INFORMED CONSENT FORM
to Participate in Research, and
AUTHORIZATION 
to Collect, Use, and Disclose Protected 
Health Information (PHI)
INTRODUCTION
Name of person seeking your consent:
Place of employment & position: 
Please read this form that describes the study in some detail. A member of the research 
team will describe this study to you and answer all of your questions.  Your participation is 
entirely voluntary.  If you choose to participate you can change your mind at any time and 
withdraw from the study.  You will not be penalized in any way or lose any benefits to which 
you would otherwise be entitled if you choose not to participate in this study or to withdraw.  
If you have questions about your rights as a research subject, please call the University of 
Florida Institutional Review Board (IRB) office at (352) 273-9600.   
GENERAL INFORMATION ABOUT THIS STUDY
1.
Name of Participant ("Study Subject")
___________________________________________________________________ 
2. What is the Title of this research study?
Establishing Normal Swallowing and Breathing Profiles in Healthy adults across the 
age span 
3. Who do you call if you have questions about this research study?
Principal Investigator: Dr. Emily Plowman, Ph.D., CCC-SLP (352)-273-9215     
Other research staff:  
Jennifer Chapin, M.S., CCC-SLP (860) 798-5009
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Danuza Nunn, M.S., CCC-SLP (617) 852-0957
Raele Robison, M.S. (610) 504-4605
Alicia K. Vose, MA CCC-SLP (860) 912-8156
4.  Who is paying for this research study? 
The sponsor of this study is the National Institute of Health, Department of Speech, 
Language and Hearing Science, College of Public Health and Health Professions at 
the University of Florida, and the Clinical and Translational Science Institute Pilot 
Research program.
5. Why is this research study being done? 
The purpose of this research study is to understand the normal function of swallowing 
and respiratory muscles in order to establish normal parameters.  This will allow us to 
compare normal physiology and function of the swallowing and respiratory muscles to 
the performance of individuals with neurodegenerative disease and stroke. It is also to 
identify clinical tests that are quick and easy to administer in a clinical setting.   
Volunteers are being asked to participate in this study in order to better understand 
normal swallowing and breathing function in order to develop treatments for 
individuals with swallowing and breathing impairments.   
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. 
At most, the Web site will include a summary of the results. You can search this Web 
site at any time.
WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY?
6.   What will be done as part of your normal clinical care (even if you did not 
participate in this research study)? 
Nothing. Normal clinical care is medical or treatment or services that you would 
receive even if you did not participate in this research study.
Participation in this study is not part of your normal clinical care and your normal 
clinical care will not be impacted regardless of whether you to choose to participate in 
this study or not.
7.  What will be done only because you are in this research study? 
Screening: Adults who are pregnant, or those with major medical conditions (i.e., 
swallowing impairment, brain injury, deviated septum, G.I. strictures obstructions, or 
Zenker’s diverticulum, surgeries to nose, neck or throat or bleeding disorders) will be 
excluded from this study. Anyone with allergy to barium or lidocaine will be excluded 
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from this study.  Those in the Communication Science Disorder field or have learned 
about their swallowing before should be excluded. Individuals with difficulty following 
directions, or uncorrected visual impairments shall be excluded. No specific gender or 
race will be excluded or targeted for participation in this study. To help the study 
personnel determine if you are eligible for the study, women who are considered to be 
of childbearing age (less then 62 years) will be asked to complete a pregnancy test to 
confirm they are not pregnant prior to performing the exam. 
Examinations: Participants in this study will be asked to attend one or more (up to 
four) appointments.  You are being asked to attend ______ appointment/s at the 
University of Florida Swallowing Systems Core Laboratory located at Shands 
Hospital, Gainesville, Florida. Each appointment is expected to take approximately 90 
minutes to complete. The specific testing that you are being asked to complete is 
checked in the list below. 
____Swallowing X-Ray Study: You are being asked to complete an X-ray of your 
swallowing, this is called a Video fluoroscopy and is like a movie x-ray of you 
swallowing foods and liquids. For this test you will be asked to sit comfortably in 
a chair and swallow barium. Barium is a substance that allows us to see how 
food and liquids flow through your mouth, throat, and esophagus during x-ray. It 
is white to the naked eye but appears black in the x-ray. Barium may be thin, 
liquid, nectar, honey, or paste consistencies. You cannot feel the x-ray while it is 
on and the total time that the x-ray machine will be on will be under five-minutes 
(although the test will take approximately ten-minutes). 
       We will ask you to swallow in three ways: First we will ask you to swallow using 
traditional cup sips of various volumes and consistencies. Secondly, we will 
place liquid in the front of your mouth and give you a "go" signal to swallow; and 
lastly, another will involve placing the liquid in the back of your mouth and into 
your throat with a tube that sits in a mouth piece we make for you. The mouth 
piece is made with standard dental putty. We will ask you to try to swallow in one 
gulp. Sometimes we will provide you with visual and/or sound cues for when to 
swallow. lf you are uncomfortable with any of these procedures at any time we 
will stop them immediately. 
We will ask you to swallow while moving your head in different directions (i.e. 
turning to the left or right, head back (chin up) or down). We will also ask you to 
swallow with your head in your regular neutral position.
____High Resolution Manometry: You are being asked to complete high resolution 
manometry testing where we will be using a small pressure tube that gets 
inserted into the nose and travels down to the back part of the throat. After the 
tube is in place in the throat, the subject will sit comfortably for five minutes to 
acclimate to the tube being in this position. After this time, they will be asked to 
swallow water or barium. They may feel a slight discomfort as the tube is being 
placed in position and as they begin to swallow the water or barium with the tube 
in place. Time to complete all swallowing-related tests will be approximately 30 
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minutes and participation in this study will require only one visit.  Individuals have 
the option to decline this procedure if uncomfortable or difficult to tolerate. 
____High Resolution Impedance Manometry: You are being asked to perform 
impedance manometry where we will be using a small pressure tube that gets 
inserted into the nose and travels down to the back part of the throat. 
After the tube is in place in the throat, the subject will sit comfortably for five 
minutes to acclimate to the tube being in this position. After this time, they will 
be asked to swallow a saline solution. Saline is a thin-water like solution that 
has a slightly salty taste. They may feel a slight discomfort as the tube is being 
placed in position and as they begin to swallow the saline with the tube in place. 
Time to complete all swallowing-related tests will be approximately 30 minutes 
and participation in this study will require only one visit.  Individuals have the 
option to decline this procedure if uncomfortable or difficult to tolerate. 
____Pulmonary Function Testing: We will ask you to perform a series of respiratory 
related maneuvers. First, we will ask you to take a deep breath in and blow out 
fast and hard into special device called a manometer, which is designed to 
record the pressure of this exhalation. Next, we will ask you to blow out all of 
your air and then quickly breathe in using the same, special device to measure 
your maximal inhalation pressure. Using a different respiratory device (a 
spirometer) we will ask you to take a deep breath in and blow out your air slow 
and steady into this equipment to measure the total amount of air volume your 
lungs can exhale. You may be asked to repeat these measures several times 
during the evaluation. There is no compensation for this test.
____Cough Testing: We will also ask you to cough into special equipment to        
measure your cough strength and ability to detect irritants in your airway. For 
one part of the cough testing we will have you breath in and out of a nebulizer 
that will contain increasing concentrations of a hot pepper vapor that will make 
you cough.  There will be a minimum of 1-minute rest time in between the cough 
trials and you will be offered water as needed. There is no compensation for this 
test.
____Tongue Pressure Examination: During the tongue examination, we will 
measure your tongue strength and the maximum amount of time that you can 
apply pressure to an air-filled tongue bulb that will rest on the roof of your 
mouth. There is no compensation for this test.
____Surface Electrical Stimulation: Surface Electrical Stimulation: Electrical 
stimulation is a widely-used treatment for dysphagia in the United States. Data 
be acquired with surface electrodes placed on the face and/or neck using the 
Dual Bio Amp (AD Instruments). All swallows in this study will be recorded with 
surface electrical stimulation for comparison with Video Fluoro Data. Surface 
electrical stimulation can be uncomfortable. We will only administer electrical 
stimulation at an intensity that is tolerable. It can also be dangerous for 
individuals with a pacemaker or any other foreign, permanent metal in the head 
and neck (excluding dental work) because the metals can become very hot or 
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interfere with their function. We are excluding these individuals. We will screen 
all patients to ensure that they do not have contraindications (pace-maker, 
foreign metal in the neck, open skin wounds) prior to administering e-stim. 
During surface electrical stimulation we will place some small electrodes on the 
surface of your skin underneath your chin. These will measure the activity of 
the muscles under that skin. 
We will use an alcohol wipe to clean the skin before placing the electrode. If 
you a male, we ask that you are clean-shaven so that the electrode can make 
good contact with that skin. We will also place a thin strap around your neck 
loosely. We will stimulate the muscles of your neck and under your chin with a 
therapeutic rehabilitation tool called electrical stimulation. You might feel a 
prickly sensation on your skin and you will feel your muscles contract. You will 
decide the strength of the stimulation, which should not be painful. We will only 
administer electrical stimulation at an intensity that is tolerable. These will 
measure the activity of the muscles under that skin.  
Tests done only for research purposes will not be evaluated or used to diagnose or 
treat any of your medical problems. 
If you have any questions now or at any time during the study, please contact one of 
the research team members listed in question 3 of this form.
8.
How long will you be in this research study?
Participation includes one 90-minute appointment with up to four follow up 
appointments or contact with participants. 
9.
How many people are expected to take part in this research study?
Up to 120 persons will participate in this study. 
WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND 
WHAT ARE YOUR OPTIONS?
10. What are the possible discomforts and risks from taking part in this research 
study?

This research study involves exposure to radiation from x-rays. The radiation 
exposure you will receive from the swallowing test (video fluoroscopy) is about 
50 millirem. This radiation exposure is equivalent to 60 days of natural 
background radiation to which people in the United States receive each year. 
The risk from this radiation exposure is considered to be minor when 
compared with other everyday risks. However, the effects of radiation add up 
over your lifetime. Repeated exposures may increase your risk of injury or 
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disease. When deciding to enter this study you should consider previous and 
future potential exposures. Examples would include x-rays taken for a broken 
bone or radiation therapy treatments for cancer. The investigator will provide 
you with a contact person if you would like more information about radiation 
exposure.

Barium will be the material used to help us see your swallow function and 
sometimes when testing is done the barium may enter your lungs during 
swallowing causing you to cough or feel some discomfort. While small 
amounts of barium ingested into the lungs does not pose a significant health 
risk, large amounts ingested over several days can lead to aspiration 
pneumonia, which is a bad respiratory infection. Therefore, we will stop the 
test if we see barium enter the airway on more than two swallows of liquid or 
food to prevent major health risk. 

The ‘hot pepper’ vapor we will use to make you cough during this part of the 
testing contains capsaicin, which comes from hot peppers.  It may cause a 
hot sensation in your mouth and throat.  This will go away within a few 
seconds after you stop inhaling breathing the capsaicin vapor. Water will be 
available to you whenever you want it.  

Although not common, it is possible that you will experience jaw and throat 
muscle soreness after you are done completing the tongue strength and 
endurance trials. This discomfort should be temporary and subside within 48 
hours.

The manometry catheter, placed through the nose into the throat, may irritate 
the gag reflex when placed. Although this is a routine clinical procedure, this 
may be uncomfortable.  This discomfort should be temporary and this 
procedure may be stopped at any point in time. 

Allergies to the following substances may prevent you from participation in 
the modality in which the substance is used. Barium allergies will prevent 
participation in Swallowing X-Ray Study. Capsaicin allergy will prevent 
participation in Cough Testing. Lidocaine allergy will prevent the optional use 
of lidocaine during manometry, but not prevent the manometry testing.   

During surface electrical stimulation we will place some small electrodes on 
the surface of your skin underneath your chin. These will measure the activity 
of the muscles under that skin. We will use an alcohol wipe to clean the skin 
before placing the electrode. If you a male, we ask that you are clean-shaven 
so that the electrode can make good contact with that skin. We will also place 
a thin strap around your neck loosely. We will stimulate the muscles of your 
neck and under your chin with a therapeutic rehabilitation tool called electrical 
stimulation. You might feel a prickly sensation on your skin and you will feel 
your muscles contract. You will decide the strength of the stimulation, which 
should not be painful. These will measure the activity of the muscles under 
that skin. 
Researchers will take appropriate steps to protect any information they collect about 
you.  However, there is a slight risk that information about you could be revealed 
inappropriately or accidentally.  Depending on the nature of the information, such a 
release could upset or embarrass you, or possibly affect your insurability or 
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employability.  Questions 17-21 in this form discuss what information about you will 
be collected, used, protected, and shared.
This study may include risks that are unknown at this time.
Participation in more than one research study or project may further increase the risks 
to you.  If you are already enrolled in another research study, please inform one of the 
research team members listed in question 3 of this form or the person reviewing this 
consent with you before enrolling in this or any other research study or project.
If you wish to discuss the information above or any discomforts you may experience, 
please ask questions now or call one of the research team members listed in question 
3 in this form.
11a. What are the potential benefits to you for taking part in this research study?
You will not personally benefit from participation in this study.
11b. How could others possibly benefit from this study?
Depending on the results of this study, we may be able to recommend procedures to 
be used by healthcare providers working with persons that have neurodegenerative 
disease or stroke and identify and manage swallowing problems earlier.
11c. How could the researchers benefit from this study?
In general, presenting research results helps the career of a scientist. Therefore, the 
Principal Investigator listed in question 3 of this form may benefit if the results of this 
study are presented at scientific meetings or in scientific journals.
None of the study members on this team have a financial interest or conflict of 
interest.
12. What other choices do you have if you do not want to be in this study? 
The option to taking part in this study is doing nothing. If you do not want to take part 
in this study, tell the Principal Investigator and do not sign this Informed Consent 
Form.
13a. Can you withdraw from this study?
You are free to withdraw your consent and to stop participating in this study at any 
time.  If you do withdraw your consent, you will not be penalized in any way and you 
will not lose any benefits to which you are entitled.  If you decide to withdraw your 
consent to participate in this study for any reason, please contact one of the research 
team members listed in question 3 of this form.  They will tell you how to stop your 
participation safely.
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If you have any questions regarding your rights as a research subject, please call the 
Institutional Review Board (IRB) office at (352) 273-9600.
13b.If you withdraw, can information about you still be used and/or collected?
If you choose to withdraw from this research study, we will no longer collect new 
information about you. We will use information that was collected prior to your 
withdrawal from the study. This information may have already been shared with 
others or we may need it to complete and protect the validity of the research. 
13c. Can the Principal Investigator withdraw you from this study? 
You may be withdrawn from the study without your consent for the following reasons:

In the event the study team members believe participation is adversely 
affecting your health.

If you are diagnosed with another medical illness that may make it difficult to 
establish normative parameters.

You are unable to completed the tasks (cannot perform the cough or tongue 
pressure trials as required)

The study is canceled. 
WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
14. If you choose to take part in this research study, will it cost you anything?
Study Services
The Sponsor will pay for all medical services activities required as part of your 
participation in this study as described above in the question “What Will Be Done Only 
Because You Are In This Research Study”. If you receive a bill for these services, 
please contact Dr. Emily Plowman at 352-273-9215.  
Items/Services Not Paid for by the Sponsor 
Any other medical services provided to you that are not directly required by this study 
will be billed to you or your insurance company in the usual manner.
15. Will you be paid for taking part in this study?
You will be paid compensation depending on the assigned procedures listed above 
for your time participating in the study. Compensation for each eligible procedure is 
$30, for total compensation of up to $120.
Your payment for participation in this research study is handled through the University 
of Florida’s Human Subject Payment (HSP) Program.  Your information which will 
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include your name, address, date of birth, and SSN (depending on amount of money 
you are paid) is protected.  Access to the (HSP) Program site is limited to certain staff 
with the assigned security role.  You will be randomly assigned a specific identification 
(ID) number to protect your identity.
The study team will provide you with an informational form called the Prepaid Card 
Facts document.  If you have any problems regarding your payment call the HSP 
Office (352) 392-9057.
16.  What if you are injured because of the study?  
If you are injured as a direct result of your participation in this study, only the 
professional services that you receive from any University of Florida Health Science 
Center healthcare provider will be provided without charge.  These healthcare 
providers include physicians, physician assistants, nurse practitioners, dentists or 
psychologists. Any other expenses, including Shands hospital expenses, will be billed 
to you or your insurance provider. 
You will be responsible for any deductible, co-insurance, or co-payments. Some 
insurance companies may not cover costs associated with research studies or 
research-related injuries. Please contact your insurance company for additional 
information. 
The Principal Investigator will determine whether your injury is related to your 
participation in this study. 
No additional compensation is routinely offered. The Principal Investigator and others 
involved in this study may be University of Florida employees. As employees of the 
University, they are protected under state law, which limits financial recovery for 
negligence.
Please contact Dr. Emily Plowman at 813-990-7095 if you experience an injury or 
have questions about any discomforts that you experience while participating in this 
study. 
17. How will your health information be collected, used and shared?
If you agree to participate in this study, the Principal Investigator will create, collect, 
and use private information about you and your health. This information is called 
protected health information or PHI. In order to do this, the Principal Investigator 
needs your authorization. The following section describes what PHI will be collected, 
used and shared, how it will be collected, used, and shared, who will collect, use or 
share it, who will have access to it, how it will be secured, and what your rights are to 
revoke this authorization. 
Your protected health information may be collected, used, and shared with others to 
determine if you can participate in the study, and then as part of your participation in 
the study.  This information can be gathered from you or your past, current or future 
health records, from procedures such as physical examinations, x-rays, blood or urine 
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tests or from other procedures or tests.  This information will be created by receiving 
study treatments or participating in study procedures, or from your study visits and 
telephone calls.  More specifically, the following information may be collected, used, 
and shared with others: 

Your entire research records (swallowing x-rays, surveys, training logs)

Name and contact information (home and email addresses, phone number)
This information will be stored in locked filing cabinets or on computer servers with 
secure passwords or encrypted electronic storage devices. 
Some of the information collected could be included in a "limited data set" to be used 
for other research purposes.  If so, the limited data set will only include information 
that does not directly identify you.  For example, the limited data set cannot include 
your name, address, telephone number, social security number, photographs, or 
other codes that link you to the information in the limited data set.  If limited data sets 
are created and used, agreements between the parties creating and receiving the 
limited data set are required in order to protect your identity and confidentiality and 
privacy.
18. For what study-related purposes will your protected health information be 
collected, used, and shared with others?
Your PHI may be collected, used, and shared with others to make sure you can 
participate in the research, through your participation in the research, and to evaluate 
the results of the research study.  More specifically, your PHI may be collected, used, 
and shared with others for the following study-related purpose(s):

Ensure that you meet the preset criteria to participate in research.

Establishing normative data for comparison with disordered populations.
Once this information is collected, it becomes part of the research record for this 
study.  
19. Who will be allowed to collect, use, and share your protected health 
information?
Only certain people have the legal right to collect, use and share your research 
records, and they will protect the privacy and security of these records to the extent 
the law allows. These people include:

the study Principal Investigator (listed in question 3 of this form) and research 
staff associated with this project.

other professionals at the University of Florida or Shands Hospital that provide 
study-related treatment or procedures.

the University of Florida Institutional Review Board (IRB; an IRB is a group of 
people who are responsible for looking after the rights and welfare of people 
taking part in research).  
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20. Once collected or used, who may your protected health information be shared 
with?
Your PHI may be shared with:

the study sponsor (listed in Question 4 of this form).

United States governmental agencies who are responsible for overseeing 
research, such as the Food and Drug Administration, the Department of Health 
and Human Services, and the Office of Human Research Protections
.

Government agencies who are responsible for overseeing public health 
concerns such as the Centers for Disease Control and federal, state and local 
health departments.
Otherwise, your research records will not be released without your permission unless 
required by law or a court order. It is possible that once this information is shared with 
authorized persons, it could be shared by the persons or agencies who receive it and 
it would no longer be protected by the federal medical privacy law.  
21. If you agree to take part in this research study, how long will your protected 
health information be used and shared with others?
Your PHI will be used and shared with others until the end of the study. After the entire 
study has finished, your PHI will be stored in a secure location and your records will 
be purged after three years.
You are not required to sign this consent and authorization or allow researchers to 
collect, use and share your PHI. Your refusal to sign will not affect your treatment, 
payment, enrollment, or eligibility for any benefits outside this research study. 
However, you cannot participate in this research unless you allow the collection, use 
and sharing of your protected health information by signing this consent and 
authorization.
You have the right to review and copy your protected health information.  However, 
we can make this available only after the study is finished.
You can revoke your authorization at any time before, during, or after your 
participation in this study.  If you revoke it, no new information will be collected about 
you.  However, information that was already collected may still be used and shared 
with others if the researchers have relied on it to complete the research.  You can 
revoke your authorization by giving a written request with your signature on it to the 
Principal Investigator.
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Consent to be Photographed, Video and/or Audio Recorded
With your permission, you will have the following done during this research (check all 
that apply):
 photographed
 video recorded
 audio recorded
Your name or personal information will not be identified on the photograph(s), video or 
audio recordings, and confidentiality will be strictly maintained.  However, when these 
photograph(s), video and/ or audio recordings are shown or heard, others may be able 
to identify you.
The Principal Investigator (PI) of this study, _________________, or her successor, will 
keep the photograph(s), video and/or audio recordings in a locked cabinet, in a folder on 
a password protected computer server drive, or as an encrypted electronic file.  These 
photograph(s), video and/or audio recordings will be shown under her direction to 
students, researchers, doctors, or other professionals and persons.
Please indicate under what conditions Dr. ________________ has your permission to 
use the photograph(s), video and/or audio recordings, and sign and date below.
  The following will be destroyed once the study is closed (initial next to all that 
apply):   
  ____ photograph(s)      _____ video recording(s)        _____ audio recording(s)
  As described in the Informed Consent Form, and for the purposes of education 
at the University of Florida Health Science Center.  The PI may keep the 
following for an indefinite period of time in a locked file, in a password protected 
computer server drive, or as an encrypted electronic file (initial next to all that 
apply): 
  ____ photograph(s)      _____ video recording(s)        _____ audio recording(s)
  As described in the Informed Consent Form; for the purposes of education at 
the University of Florida Health Science Center; and for presentations at 
scientific meetings outside the University.  The PI may keep the following for 
an indefinite period of time in a locked file, in a password protected computer 
server drive, or as an encrypted electronic file (initial next to all that apply):
  ____ photograph(s)      _____ video recording(s)        _____ audio recording(s)
Signature
Date
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SIGNATURES
As an investigator or the investigator’s representative, I have explained to the participant 
the purpose, the procedures, the possible benefits, and the risks of this research study; 
the alternative to being in the study; and how the participant’s protected health 
information will be collected, used, and shared with others: 
Signature of Person Obtaining Consent and 
Authorization
Date
You have been informed about this study’s purpose, procedures, possible benefits, and 
risks; the alternatives to being in the study; and how your protected health information will 
be collected, used and shared with others.  You have received a copy of this Form.  You 
have been given the opportunity to ask questions before you sign, and you have been told 
that you can ask   questions at any time.  
You voluntarily agree to participate in this study. You hereby authorize the collection, use 
and sharing of your protected health information as described in sections 17-21 above.  By 
signing this form, you are not waiving any of your legal rights.
Signature of Person Consenting and Authorizing
Date
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SAP_001.pdf: 
Title: Establishing Normal Swallowing and Breathing Profiles in Healthy adults across the age span  
NCT: 03122145 
Date: March 1, 2019  
 


Experiment #1: Statistical Analysis Plan 
 
Table 1. Test domains and corresponding outcome variables. 
Domain 
Test 
Outcome Variable 
Cough 
Reflexive cough testing:  
Capsaicin: (0,50,100,150,200uM) 
Suprathresholds: 
Capsaicin: 200uM 
-Motor threshold: cough total (ordinal) 
-Sensory threshold: Urge-to-cough rating 
(ordinal) 
-Log transformed Urge-to-cough sensitivity 
slopes (continuous) 
-Motor: peak expiratory cough flow (continuous) 
 
Table 2. Specific aims, associated measurements and apriori statistical analyses 
Aim 
Design  
Measurement 
Apriori Analysis 
1 
Reflex cough 
thresholds 
Between 
group 
comparison 
Sensory and Motor Reflex 
cough thresholds (ordinal) 
Mann-Whitney U test comparing   
reflex cough thresholds of ALS individuals 
vs. age/gender matched healthy controls 
2 
Dose-
dependent 
response 
curves 
Between 
group 
comparison 
Urge to cough sensitivity 
(continuous) 
A slope calculated by plotting the UTC ratings against 
capsaicin concentration on a log-log scale, and fitting a 
linear regression line to the data. Comparisons 
between ALS vs. controls 
3 
Voluntary 
cough 
Between 
group 
Peak expiratory cough flow  
Mann Whitney U between groups comparison for 
voluntary cough parameters between healthy controls 
and individuals with ALS outcomes: peak expiratory 
cough flow  
 


Experiment #2: Statistical Analysis Plan 
 
For Laryngeal Vestibule Closure (LVC) timing measures, a linear mixed effects model was used to 
compare the duration of LVC and duration to LVC among the swallow conditions. Pairwise 
comparisons were used when fixed effects were significant (Sidak corrected). Outcomes from both 
analyses were significant at p ≤ .05. Interrater reliability (20% of the data) and intrarater reliability (5% 
of the data) for the timing of LVC measures were analyzed using single-measure intraclass 
correlation coefficients (ICCs). ICC estimates and their 95% confidence intervals were calculated with 
a consistency of agreement definition. All samples were randomly selected for reliability.