Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Sponsor: Purdue University

Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS 
NCT05003167 
Study Protocol and Statistical Analysis Plan 
February 22, 2022

Study Design: 
Participants attended five assessment sessions which spanned nine weeks (Week 1: Baseline 1, 
Week 2: Baseline 2, Week 3: Pre-Training, Week 6: Mid-Training, Week 9: Post-Training) in the 
multiple baseline design depicted in Figure 2. During the six-week training phase, participants 
attended one telepractice session per week. Thus, participants attended nine total sessions. 
 
 
 
 
While enrolled, participants were not allowed to participate in active speech therapy treatment 
programs but were allowed to see speech-language pathologists as part of routine ALS clinic visits. 
Participants were allowed to follow their prescribed medication regimens. 
 
General Procedures:  
Study procedures were approved by Purdue University’s Institutional Review Board (IRB-2020-
524). Participants were recruited via contact with neurologists, ALS Association support groups, 
ALS clinics, and ClinicalTrials.gov (identifier: NCT05003167). Potential participants contacted the 
researchers to express interest in the study. Once initial contact had been established, a pre-
enrollment phone call was scheduled during which the researchers provided potential participants 
with more information about the study. If the potential participant remained interested, 
participants verbally consented to being asked a series of questions related to their overall health 
and ALS diagnosis. This pre-enrollment screening was intended to ensure that participants met the 
inclusion criteria and were likely in the early stages of disease progression. If the potential 
participant met the study requirements and elected to enroll, the equipment (peak flow meter and 
EMST-150/EMST75 Lite) was sent for delivery and the first baseline session was scheduled.   
 
During the Baseline 1 session, study procedures were described to the participant in detail. Once all 
questions about the study had been answered, the participant reviewed and signed the consent 
form virtually using Adobe EchoSign. Following consent, participants were administered the MoCA 
4.1. The MoCA was adapted in accordance with the telepractice guidelines outlined on the MoCA 
website (mocatest.org) to compatible for administration through telepractice.  
 
All assessment and telepractice sessions were audio and video recorded through Zoom (versions 
5.8.4 and 5.9.1). Participants were allowed to use the electronic device of their choosing (e.g., 
phone, tablet, computer) for all sessions, but were required to use the same device for all sessions. 
However, 1 participant’s (M24) computer broke prior to the Post-Training session; thus, he used a 
new device for the last assessment session. Device types used by participants were documented at 
each session: nine participants used a computer and three used a tablet. The researcher used the 
same electronic device for all sessions (MacBook Pro 2020). 
 
Initial Surveys: 

Participants completed a series of surveys in REDcap throughout the study (Harris et al., 2009). A 
general health and demographics survey was completed at Baseline 1. Participants were sent a link 
and access code to the REDCap surveys which asked them questions related to their demographics 
and overall health. These items included: race/ethnicity, estimated height and weight (to compute 
BMI), highest education received, date of birth, date of first symptoms, date of diagnosis, 
description of first symptoms, medical history, medications list, and history of speech/swallowing 
therapy.  
 
The Beck Depression Inventory (Beck et al., 1988) is a 21-item survey that was completed at 
Baseline 1 to quantify symptoms of depression which might influence the study aims. Scores range 
from 1-63 with higher scores indicating greater depression (1-10: these ups and downs are 
considered normal, 11-16: mild mood disturbance, 17-20 borderline clinical depression, 21-30 
moderate depression, 31-40 severe depression, 40: extreme depression). Two participants scored 
within the moderate depression range, 3 participants scored within the mild mood disturbance 
range, and all remaining participants scored within normal range. Participant Beck Depression 
Inventory scores are listed in Table 1.  
 
The Apathy Evaluation Scale (Guercio et al., 2015) is an 18-item survey which quantifies goal 
directed behavior that might influence the study aims. The participants use a 4-point Likert scale 
(not at all true, slightly true, somewhat true, and very true) to rate the 18 items. The scores range 
from 18 to 72 with lower scores indicating greater apathy.  
 
ALS Function Rating Scale-Revised (ALSFRS-R) (Cedarbaum et al., 1999) was used to assess overall 
physical functionality related to ALS. The survey requires participants to rate how 12 physical 
functions are impacted by their ALS. The functions include speech, salvation, swallowing, 
handwriting, cutting food and handling utensils, dressing and hygiene, turning in bed and adjusting 
bed sheets, walking, climbing stairs, dyspnea, orthopnea, and respiratory insufficiency. For each 
function, participants are provided with a 4-point Likert scale to rate whether they still have 
complete control of that function (4) or no ability to perform that function (0). Total scores range 
from 0 to 48, with lower scores indicating more severe symptoms and higher scores and less severe 
symptoms. An ALSFRS-R score was collected at Baseline 1, Baseline 2, Pre-Training, and Post-
Training. During the Baseline 1 session, the researcher administered the ALSFRS-R. For all other 
instances, the participants completed the ALSFRS-R independently via REDCap.  
 
Training: 
The EMST-150 and EMST75 Lite devices were used to obtain estimations of participants maximum 
expiratory pressure (MEP) and for training. Both devices house a calibrated spring-loaded valve 
that overloads the expiratory muscles at a targeted pressure. An adjustable spring within the device 
allows for blocking of airflow until the targeted expiratory pressure is produced and the device is 
only open while the targeted expiratory pressure is maintained. The two EMST devices are the 
same except for the resistance levels available on each device. The EMST-150 device has resistance 
levels ranging from 30-150 cmH2O. The EMST75 Lite device has resistance levels between 0 and 75 
cmH2O. All participants were initially sent an EMST-150 device, but if they were unable to 
successfully exhale into the EMST-150 to release the valve at its lowest setting during the Baseline1 
session, they were sent an EMST75 Lite to accommodate their lower expiratory force. The eight 
male participants used an EMST-150 and four female participants used an EMST75 Lite device for 
training. All participants chose to utilize the comfort-fit mouthpiece to help maintain adequate lip 
seal around the device. 
 

During the training phase, participants attended one tele-session per week with a researcher (the 
doctoral student and certified speech-language pathologist leading the study). During each weekly 
session, the participant’s MEP was estimated. After the participant’s MEP was estimated, the EMST 
device’s resistance level was placed at 50% of their estimated MEP. The participants were 
instructed to follow the rule of five to complete five sets of five (25 total) exhalations into the EMST 
device five days a week for six weeks. Participants were encouraged to complete the 25 exhalations 
in one sitting. To ensure the device was being utilized appropriately, participants completed 
twenty-five exhalations into the device with the researcher’s supervision during each weekly tele-
session. Thus, they completed four training sessions independently and one day of training via tele-
practice with the researcher. Compliance with the training protocol was monitored using a daily 
adherence survey sent to the participants via REDCap. On the survey, the participants indicated 
whether (yes/no) they completed the training protocol each day, and if not, why, as well as whether 
they needed assistance to complete the training on each day.  
 
Assessments: 
 
Surveys: Surveys were completed independently by participants on REDCap. 
 
Maximum expiratory pressure: To obtain MEP estimations, the participant always started with the 
EMST device on its lowest setting. If the participant was able to successfully release the valve at the 
device’s lowest setting, the participant was instructed to increase the resistance level of the device 
by moving the screw on the adjustable knob in one-turn increments until they reached a point 
where they could no longer force the valve open with their expiratory force. At that point, 
participants decreased the device’s resistance level in quarter-turn increments until they could 
force the valve open again. The maximum level at which participants could exhale into the device 
was considered their estimated MEP for the respective session. Successful valve release occurred 
when the participant or researcher heard the air escaping, while unsuccessful valve release 
occurred when a release of air was not heard. To ensure the participant was accurately adjusting 
the device in appropriate increments, they were instructed to move the screw in full and quarter 
turn increments using the four blue (EMST-150) or green (EMST Lite) plastic gridlines positioned 
in quarterly increments at the bottom of the device as a guide. Participants showed the screws 
location to the researcher periodically as MEP was being estimated to make sure they were on 
track. Once the participant’s estimated MEP was determined, the participant showed the final 
location of the screw to the researcher to confirm that the estimated MEP was accurate. 
 
Speech Tasks: Participants were instructed to sit upright in front of their electronic device so that 
the researcher could visualize his/her torso and mouth without difficulty. To enhance visualization 
of respiratory patterns, participants wore a cloth band (Tobwolf self-adhesive bandage wraps, plaid 
pattern) loosely wrapped around their ribcage while they completed the speech tasks. Participants 
were instructed to read The Rainbow Passage (see Appendix A) and produce a sixty second 
monologue discussing a topic of his/her choice. The order of the speech tasks was randomized for 
each session. Acoustic recordings of the reading passage and monologue were obtained as mp4 files 
from the audio/video recordings collected via Zoom. mp4 files were then converted to wav files via 
iTunes to be compatible with Praat for the acoustic analyses.  
 
Cough Tasks: Peak expiratory flow rate (liters per minute) from single and sequential voluntary 
coughs were obtained from a Peak Flow Meter (Omron PF9940 PeakAir) sent to the participants 
prior to the Baseline 1 session. For the single voluntary coughs, participants were cued to produce 
one single strong cough into the device following a clinician model. For the sequential voluntary 
coughs, participants were instructed to “cough forcefully multiple times as if something went down 

the wrong pipe” following a clinician model of producing three sequential coughs. The maximum 
peak expiratory flow rate was determined from three consistent (within 5%) peak expiratory flow 
rate values for each cough type. If the first three trials were not consistent, participants were 
instructed to complete up to two additional coughs for single and sequential coughs. To prevent 
over-exertion, no more than a total of five attempts per cough type were allowed. 
 
Statistical Analysis Plan: 
 
Maximum expiratory pressure, speech outcomes, cough outcomes: A mixed model ANOVA with 
session as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05. 
Reading and monologue tasks were assessed separately. To assess individual change in estimated 
MEP from Pre- to Post-Training, effect sizes were computed for each participant using the following 
formula: 
Post Mean – Pre Mean / Pre standard deviation 
 
Survey outcomes: Paired t-tests were run in JMP (Version Pro 16). 
 
 
 

IRB No. IRB 2020 524 
Page 1 
RESEARCH PARTICIPANT CONSENT FORM 
Expiratory Muscle Strength Training for Early-Stage Amyotrophic Lateral Sclerosis 
Jessica E. Huber, PhD 
Speech, Language, and Hearing Sciences Department 
Purdue University 
 
 
Key Information 
Please take time to review this information carefully. This is a research study. Your 
participation in this study is voluntary which means that you may choose not to participate at 
any time without penalty or loss of benefits to which you are otherwise entitled. You may ask 
questions to the researchers about the study whenever you would like. If you decide to take part 
in the study, you will be asked to sign this form. Prior to doing so, please be sure you understand 
what you will do as a part of the study and any possible risks or benefits. The researcher is 
willing to answer all questions you might have. 
Amyotrophic Lateral Sclerosis (ALS) causes muscles to weaken. Muscles involved in 
breathing, eating, speaking, and coughing are of interest in this study. These muscles are 
typically strengthened with an expiratory muscle strength trainer – a device that works much 
like how lifting a weight strengthen the biceps. Expiratory muscle strength trainers improve 
cough, swallowing, communication, and breathing for healthy people and people with 
neurological diseases (e.g., Parkinson’s disease). A recent study found that using an expiratory 
muscle strength trainer is safe and beneficial for people with ALS, as it strengthens the muscles 
involved with breathing. This study aims to determine whether expiratory muscle strength 
training improves speech, cough, and breathing strength for people with ALS. Another aim is to 
determine whether expiratory muscle strength training can be done through telehealth.  
 
The study is ten weeks. All meetings will take place virtually through Zoom. It requires 
participants to attend 5 virtual assessment sessions (~1 hour each) and 12 virtual training 
sessions (2x/week for six weeks, ~30 minutes each session), complete an at-home respiratory 
strength training program (~25 minutes/day, 5 days/week, for 6 weeks), and complete a series of 
surveys (~3 hours).  
 
What is the purpose of this study? 
 
You are being asked to participate in this study because you have a diagnosis of ALS and 
are within the early stages of disease progression. We would like to enroll 30 individuals with 
early-stage ALS.  
 
The purpose of this study is to provide information on whether expiratory muscle strength 
training improves communication, cough, and breathing for people with ALS when implemented 
through telehealth.  
 
What will I do if I choose to be in this study?  
 
 
If you agree to participate in this 10-week study, you will need to attend 5 virtual assessment 
sessions. During the training phase of the study (weeks 4-10), you will use the trainer 5 days per 
week for about 20-30 minutes a day and meet with a speech-language pathologist virtually 2x per 
week for ~30 minutes each session. You will also complete a series of surveys pre- and post-

IRB No. IRB 2020 524 
Page 2 
training to monitor your quality of life, ALS progression, communication, breathing patterns, and 
compliance with the training.  
 
The clinical researchers who will guide you throughout the study have experience working with 
people who have neurodegenerative diseases including ALS. 
 
Training protocol: Expiratory muscle strength training uses a device which you exhale into in 
order to strengthen the muscles used for breathing – muscles that are also important for speaking, 
swallowing, and coughing strongly. You will need to breathe out into the device 25 times a day, 
five days per week, for six weeks. A caregiver/loved-one may be required to help you use the 
device should any difficulties arise.  
 
Assessment surveys: On the day of each data collection visit, you will first complete a series of 
surveys and questionnaires. If any concerning issues are raised by your responses to the 
questionnaires or other information arises that would be of interest to your health, we will inform 
you and offer to provide the information to your neurologist or primary care physician.  
 
The following screenings will be administered at the first assessment session only. We estimate 
they should take approximately 20 minutes to complete.   
1. You will complete a health questionnaire 
2. We will administer a brief test of your thinking skills  
3. We will briefly test the muscles of your face   
 
You will complete the following surveys online. The series of surveys should take you 
approximately 20 minutes to complete (~40 minutes total throughout the entire study).  
1. ALS Quality of Life Scale Revised (Pre- and Post-Training): A 50-item questionnaire that 
measures how ALS effects your overall quality of life .  
2. ALS Function Rating Scale Revised (Pre- and Post-Training): A survey that monitors 
overall disease severity.  
3. Communication Participation Item Bank (Pre-Training and Post-Training): A 10-item 
questionnaire that asks about your involvement in conversations.  
4. A System Usability Scale (Post-Training only): To assess how usable you felt the training 
device was.   
5. Psychosocial Impact of Assistive Devices Scale (Post-Training only): To understand 
whether the training influenced your psychosocial state.  
6. Telehealth Satisfaction Questionnaire (Post-Training only): to understand your perception 
of completing the training protocol online via telehealth.  
 
Each week of the training phase, you will also complete the following survey online. The survey 
should take you no more than 5 minutes to complete (~1 hour throughout the study).  
1. Compliance: A daily log will be to monitor your adherence to the training.   
2. Dyspnea Visual Analog Scale: A 0-10 rating scale that measures any breathing difficulty 
encountered after completing the training.  
 
Assessment Tasks: Additionally, during the five assessment sessions, we will collect data that 
will allow us to make measurements of speech, breathing, coughing, and respiratory muscle 
strength. These tasks include:  
1. Speech tasks: These tasks will be recorded via Zoom. You will be asked to talk for a 
period of 2 minutes about a topic of your choice and you will read a short story. In total, 
these will take approximately 5 minutes.  

IRB No. IRB 2020 524 
Page 3 
2. Breathing tasks: For these tasks, you will be asked to breathe out as hard as you can into 
an expiratory muscle strength trainer device. This task will take approximately 10 
minutes.  
3. Cough testing: During the cough testing, we will ask you to cough into a peak flow meter. 
These tasks will take approximately 15 minutes.  
 
Our laboratories record the video and audio from all sessions. You have the option to sign a 
separate consent form for us to use your sound and video recordings for educational purposes. 
You will not be excluded from the study if you choose not to sign the audio/video consent form.  
 
How long will I be in the study?  
If you agree to participate, you will be in the study for 10 weeks. During the first three weeks of 
the study, you will attend 3 virtual assessment sessions. During these sessions, you will complete 
surveys as well as the speech, breathing, and cough tasks outlined above. The first 3 sessions will 
allow us to capture a clear picture of your baseline measurements which we will later compare 
your post-training measures to. You will attend two additional virtual assessment sessions during 
the training portion of the study (at weeks 7 and 10) and 2 virtual training sessions per week 
(between weeks 3 and 10). 
 
Each assessment session should take approximately 1 hour (~5 hours total throughout the study). 
You will complete the training daily in the comfort of your home. The training protocol should 
take no more than 15 minutes for you to complete each day (~7.5 hours total throughout the 
study). The surveys should take approximately 20 minutes to complete at each timepoint (~4.5 
hours total throughout the study).  
 
What are the possible risks or discomforts? 
The expiratory muscle strength training device poses minimal risk to you. A small study 
completed in 2015 found moderate-intensity expiratory muscle strength training to be safe for 
individuals with early-stage ALS. All of the evaluation procedures have been used frequently in 
our laboratory and by the doctoral student leading the study. We have a strict data safety 
monitoring plan in place to reduce any risks while you undergo the training program. If we 
observe a significant decline in function on the assessment tasks or surveys you complete while in 
the study, we will provide the results to you and to your physician of choice. If the declines are 
significantly greater than expected based on your baseline testing, we will cease training.  
 
There is a small chance that you might be uncomfortable answering some questions on the 
questionnaires. If this is the case, you will have the option to omit any questions. 
Breach of confidentiality is always a risk with data, but we will take precautions to minimize this 
risk as described in the confidentiality section.  
 
Are there any potential benefits?     
If expiratory muscle strength training proves to be effective for you, you may benefit from 
improved breathing, speech production, swallowing, coughing, and/or quality of life. Because this 
training has been minimally studied with people who have ALS, these effects cannot be 
guaranteed. The testing procedures that you will complete for this research will likely improve 
our understanding of the benefits associated with expiratory strength training and other active 
sources of treatment for people with ALS.  
 
What alternatives are available?  
If you choose not to participate in this study, you may consider obtaining speech-pathology, 
respiratory, and/or pulmonology services within the community. 

IRB No. IRB 2020 524 
Page 4 
 
Will I receive payment or other incentive?  
You will be compensated up to a total of $250 dollars for your participation in the study ($40 per 
session plus an additional $50 dollars for completing the study). Participants who complete the 
entire study protocol will be awarded an additional $50 dollars at the end of the study. An 
additional incentive provided to participants is that you will receive a comprehensive evaluation 
of your speech, breathing, cough, and swallow abilities at no additional cost to you. We will 
provide a complete written report for you. You will be compensated via check after you attend the 
final session. If you voluntarily choose to stop participating, or if your participation is terminated 
by the researcher, you will be pro-rated for the number of data collection sessions you completed. 
Participants who attend the initial baseline data collection session and do not pass the screenings 
(see above), will be compensated $10 for their time. For payments over $50, we will need to 
provide Purdue University’s business office with your name, social security number, and address.  
 
Are there costs to me for participation?  
 
No.  
 
This section provides more information about the study 
 
What happens if I become injured or ill because I took part in this study?  
If you feel you have been injured due to participation in this study, please contact Jessica Huber, 
Professor at Purdue University; Brianna Kiefer, PhD Student at Purdue University; or Sandy Snyder, 
Research Associate at Purdue University at 765-494-6488. You may also contact Michelle Troche, 
Associate Professor at Columbia University, at (212) 678-3953.  
 
Purdue University will not provide medical treatment or financial compensation if you are injured or 
become ill as a result of participating in this research project. This does not waive any of your legal 
rights nor release any claim you might have based on negligence. 
 
Will information about me and my participation be kept confidential? 
The project's research records may be reviewed by the study sponsor/funding agency (the National 
Institutes of Health), Food and Drug Administration (if FDA regulated), US DHHS Office for Human 
Research Protections, and by departments at Purdue University responsible for regulatory and research 
oversight. 
 
Your confidentiality will be kept throughout the entire duration of the study. The results of this study 
will be used to advance the understanding of the effects expiratory muscle strength training on speech, 
breathing, swallowing, and cough outcomes for people with ALS. The findings will be disseminated 
through presentations at conferences and meetings, through in-services with clinicians and published 
journals. Any presentation or publications that result from this study will only use de-identified data. 
Your information will not be disclosed when the results are published or presented at the completion of 
the study. Your records (questionnaires, audio recordings, swallowing videos, etc.) will be assigned an 
anonymous number that is unrelated to your personal information. Your subject number and all data 
will have no personal identifiers. All digitized data will be de-identified and stored indefinitely in a 
password protected, encrypted server. Only the investigators and lab associates who are working on the 
project will have access to your records and data. Our collaborators at Columbia University will also 
have access to your de-identified data. All paper surveys and data will also be de-identified and locked 
in a file cabinet in the principal investigators’ laboratories, the Motor Speech Laboratory in Lyles-
Porter Hall at Purdue University or the Upper Airway Dysfunction Laboratory in Thorndike Hall at 
Columbia University. When records are destroyed, paper records will be shredded and computer files 

IRB No. IRB 2020 524 
Page 5 
will be deleted. For compensation purposes, your name, address, and social security number will be 
provided to the business office at Purdue University. Only trained staff in the Motor Speech and Upper 
Airway Dysfunction Laboratories will have access to the excel sheet which includes your name, 
address, and de-identified subject number. 
 
It is possible that we will use the recordings of your speech at a later point in time for follow-up 
studies. Follow-up studies may involve perceptual ratings of your speech recordings by unfamiliar 
listeners from the community. While we have no immediate intent to complete this potential follow-
up study, we will employ the same confidentiality procedures described above for any of your data 
we may use in the future.  
 
Clinicaltrials.gov: A description of this clinical trial will be available on ClinicalTrials.gov, as required 
by U.S. Law.  This website will not include information that can identify you.  At most, the Website 
will include a summary of the results.  You can search this Website at any time. 
 
Certificate of Confidentiality: This research is covered by a Certificate of Confidentiality from the 
National Institutes of Health. The researchers with this Certificate may not disclose or use information, 
documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, 
administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if 
there is a court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected 
with the research except, if there is a federal, state, or local law that requires disclosure (such as to 
report child abuse or communicable diseases but not for federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, 
including for your medical treatment; or if it is used for other scientific research, as allowed by federal 
regulations protecting research subjects.  For additional information about CoCs see 
http://grants.nih.gov/grants/policy/coc/faqs.htm.” 
 
What are my rights if I take part in this study? 
You do not have to participate in this research project. If you agree to participate, you may 
withdraw your participation at any time without penalty. Contact Jessica Huber, Brianna Kiefer, 
or Sandy Snyder at (795) 464-6488 at Purdue University if at any time you wish to withdraw your 
participation. You may also contact Michelle Troche at (212) 678-3953 at Columbia University.  
 
If the research team notices significant decline in your function above that expected from your 
baseline sessions, you may be dismissed by the research personnel without consent. Weekly 
monitoring checks via your survey completions and physical changes noted during assessments 
will take place. If you do not complete these weekly surveys, you may be dismissed by the 
research team without consent. If the research team dismisses you from the study, it is with your 
best interest in mind given that this training program is a relatively novel treatment program for 
people with ALS and we do not wish to inflict harm on anyone who participates.   
 
 
Who can I contact if I have questions about the study? 
If you have questions, comments or concerns about this research project, you can talk to one of 
the researchers. Please contact Jessica Huber, Brianna Kiefer, or Sandy Snyder at Purdue 
University at (795) 464-6488, or Michelle Troche at Columbia University at (212) 678-3953.  
 
To report anonymously via Purdue’s Hotline see www.purdue.edu/hotline  
 

IRB No. IRB 2020 524 
Page 6 
If you have questions about your rights while taking part in the study or have concerns about the 
treatment of research participants, please call the Human Research Protection Program at (765) 494-
5942, email (irb@purdue.edu) or write to:  
Human Research Protection Program - Purdue University  
Ernest C. Young Hall, Room 1032  
155 S. Grant St.  
West Lafayette, IN 47907-2114  
 
Future Use 
Can we use the data (speech recordings, survey responses, health information) collected through this 
study in future research studies we conduct on ALS, respiratory function, or quality of life?  
 
Yes                 
 
 No 
 
Documentation of Informed Consent 
I have had the opportunity to read this consent form and have the research study explained.  I have had 
the opportunity to ask questions about the research study, and my questions have been answered.  I am 
prepared to participate in the research study described above.  I will be offered a copy of this consent 
form after I sign it.   
 
 
__________________________________________                           _________________________ 
              Participant’s Signature                                                                                  Date 
  
__________________________________________                           
              Participant’s Name 
 
__________________________________________                          ___________________________ 
              Researcher’s Signature                                                                                  Date