Predictors of Response to Insomnia Treatments for Gulf War Veterans
Phase: NA
Conditions: Insomnia
Sponsor: VA Office of Research and Development

Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025
Personnel Info .............................................................................................................
2
Participant Population .................................................................................................
3
Study Location ............................................................................................................
4
General Checklist ........................................................................................................
4
Funding .......................................................................................................................
6
Resources ....................................................................................................................
7
Purpose, Study Procedures .......................................................................................... 9
Radioisotopes or Radiation Machines ......................................................................... 15
Drugs,Devices,Reagents ............................................................................................. 16
Medical Equipment for Human Subjects and Laboratory Animals ............................ 17
Participant Population(a-g) ......................................................................................... 17
Participant Population(h-m) ........................................................................................ 18
Risks(a-e) .................................................................................................................... 21
Privacy And Confidentiality ....................................................................................... 24
Conflict Of Interest ..................................................................................................... 24
Consent Background ................................................................................................... 28
Assent Background ..................................................................................................... 33
HIPAA Background .................................................................................................... 33
Attachments ................................................................................................................. 34
Obligations .................................................................................................................. 38
eProtocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 1 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University

Protocol Director
Name
Jerome A Yesavage
Degree (Program/year if
student)
MD
Position, e.g. Assistant Professor,
Resident, etc.
Professor
Department
Psych/Public Mental
Health & Population
Sciences
5550
Phone
(650) 852-3287
(650) 852-3297 E-mail
yesavage@stanford.edu
CITI Training current
Y
Admin Contact
Name
Abigail E Cirelli
Degree (Program/year if
student)
BA
Position, e.g. Assistant Professor,
Resident, etc.
Assistant Clinical Neuroimaging
Research Coordinator
Department
Psych/Sleep Medicine
5797
Phone
(650) 723-1299
E-mail
acirelli@stanford.edu
CITI Training current
Y
Investigator
Name
Andrea Nicole Goldstein
Degree (Program/year if
student)
PhD
Position, e.g. Assistant Professor,
Resident, etc.
Clinical Assistant Professor
Department
Psych/Major
Laboratories and
Clinical &
Translational
Neurosciences
Incubator
5797
Phone
493-5000
E-mail
agoldpie@stanford.edu
CITI Training current
Y
Other Contact
Name
Eileen Grace Fischer
Degree (Program/year if
student)
BS
Position, e.g. Assistant Professor,
Resident, etc.
Lab Admin
Department
Psych/Public Mental
Health & Population
Sciences
Phone
210 993 2065
E-mail
grace.fischer@stanford.edu
CITI Training current
Y
Academic Sponsor
Name
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 2 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Department
Phone
E-mail
CITI Training current
Other Personnel
Name
Laura Lazzeroni
Degree (Program/year if
student)
PhD
Position, e.g. Assistant Professor,
Resident, etc.
Associate Professor
Department
Psych/General
Psychiatry and
Psychology (Adult)
5485
Phone
(650) 723-0947
E-mail
Lazzeroni@stanford.edu
CITI Training current
Y
Name
Arthur Noda
Degree (Program/year if
student)
MA
Position, e.g. Assistant Professor,
Resident, etc.
Software Developer, Research
Department
5550
Phone
(650) 493-5000
ext. 64493
(650) 852-3297 E-mail
artnoda@stanford.edu
CITI Training current
Y
Name
Donn Posner
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Adjunct Clinical Associate Professor
Department
Psych/Sleep Medicine
5717
Phone
E-mail
Donn.posner@va.gov
CITI Training current
Y
Name
Beatriz Hernandez
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Data Analyst
Department
Psych/Public Mental
Health & Population
Sciences
5550
Phone
(650) 852-3287
E-mail
bhernandez@stanford.edu
CITI Training current
Y
Name
Pandora Lam
Degree (Program/year if
student)
Position, e.g. Assistant Professor,
Resident, etc.
Assistant Clinical Neuroimaging
Research Coordinator
Department
Psych/Sleep Medicine
5797
Phone
E-mail
pal217@stanford.edu
CITI Training current
Y
Participant Population(s) Checklist
Yes/No
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 3 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

• Children (under 18)
N
• Pregnant Women and Fetuses
N
• Neonates (0 - 28 days)
N
• Abortuses
N
• Prisoners
N
• International Participants
N
Please enter the countries separated by comma
• Impaired Decision Making Capacity
N
• Cancer Subjects
N
• Laboratory Personnel
N
• Healthy Volunteers
Y
• Students
N
• Employees
N
• Other (i.e., any population that is not specified above)
N
Study Location(s) Checklist
Yes/No
• Stanford University
• Clinical & Translational Research Unit (CTRU)
• Stanford Medicine Health Care
Tri-Valley
• Stanford Medicine Children's Health
• VAPAHCS (Specify PI at VA)
Y
Jerome A. Yesavage, MD
• Other (Click ADD to specify details)
General Checklist
1. Multi-site
Yes/No
• Is this a multi-site study? A multi-site study is generally a study that involves one or more
medical or research institutions in which one site takes a lead role.(e.g., multi-site clinical
trial)
Y
• Is Stanford the coordinating institution or are you the lead investigator for this multi-site
study?
Y
Site Name
Contact Name Contact
Phone
Contact Email
Permission?
Engaged?
WRIISC New
Jersey
Drew A.
Helmer, MD
800-248-800
5
drew.helmer@va.gov
Y
Y
WRIISC
Washington DC
Matthew
Reinhard,
800-722-834
0
matthew.reinhhard@va.gov
Y
Y
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 4 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Psy.D.
2. Collaborating Institution(s)
Yes/No
• Are there any collaborating institution(s)? A collaborating institution is generally an
institution that collaborates equally on a research endeavor with one or more institutions.
N
3. Cancer Institute
Yes/No
• Cancer-Related Studies (studies with cancer endpoints), Cancer Subjects (e.g., clinical
trials, behavior/prevention) or Cancer Specimens (e.g., blood, tissue, cells, body fluids with
a scientific hypothesis stated in the protocol).
N
4. Clinical Trials
Yes/No
• Investigational drugs, biologics, reagents, or chemicals?
N
• Commercially available drugs, reagents, or other chemicals administered to subjects that
are being studied?
N
• Investigational Medical Device / Commercial Medical Device used off-label or if being
studied?
N
• IDE Exempt Device (Commercial Medical Device used according to label, Investigational
In Vitro Device or Assay, or Consumer Preference/Modifications/Combinations of
Approved Medical Devices)
Y
• Will this study be registered on clinicaltrials.gov? ( See Stanford decision tree )
Y
• Who will register for ClinicalTrials.gov?
NCT# 03208049
Y
5. Tissues and Specimens
Yes/No
• Human blood, cells, tissues, or body fluids (tissues)?
Y
• Tissues to be stored for future research projects?
Y
• Tissues to be sent out of this institution as part of a research agreement? For guidelines,
please see Material Transfer Agreements
N
6. Biosafety (APB)
Yes/No
• Are you submitting a Human Gene Transfer investigation using a biological agent or
recombinant DNA vector? If yes, please complete the Gene Transfer Protocol Application
Supplemental Questions and upload in Attachments section.
N
• Are you submitting a Human study using biohazardous/infectious agents? If yes, refer to
the Administrative Panel on BioSafety website prior to performing studies.
N
• Are you submitting a Human study using samples from subjects that are known or likely to
N
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 5 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

contain biohazardous/infectious agents? If yes, refer to the Administrative Panel on
BioSafety website prior to performing studies.
7. Human Embryos or Stem Cells
Yes/No
• Human Embryos or Gametes?
N
• Human Stem Cells (including hESC, iPSC, cancer stem cells, progenitor cells)
N
8. Veterans Affairs (VA)
Yes/No
• The research recruits participants at the Veterans Affairs Palo Alto Health Care
System(VAPAHCS).
Y
• The research involves the use of VAPAHCS non-public information to identify or contact
human research participants or prospective subjects or to use such data for research
purposes.
Y
• The research is sponsored (i.e., funded) by VAPAHCS.
Y
• The research is conducted by or under the direction of any employee or agent of
VAPAHCS (full-time, part-time, intermittent, consultant, without compensation (WOC),
on-station fee-basis, on-station contract, or on-station sharing agreement basis) in
connection with her/his VAPAHCS responsibilities.
Y
• The research is conducted using any property or facility of VAPAHCS.
Y
9. Equipment
Yes/No
• Use of Patient related equipment? If Yes, equipment must meet the standards established by
Biomedical Engineering (BME) (650-725-5000)
Y
• Medical equipment used for human patients/subjects also used on animals?
N
• Radioisotopes/radiation-producing machines, even if standard of care? ; More Info
N
10. Payment
Yes/No
• Subjects will be paid/reimbursed for participation? See payment considerations.
Y
11. Funding
Yes/No
• Training Grant?
N
• Program Project Grant?
N
• Federally Sponsored Project?
N
• Industry Sponsored Clinical Trial?
N
Funding
NONE
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 6 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Funding - Grants/Contracts
Funding - Fellowships
Gift Funding
Dept. Funding
Other Funding
Resources :
a)
Qualified staff.
Please state and justify the number and qualifications of your study staff.
Jerome Yesavage, MD. Dr. Yesavage is Associate Chief of Staff for Mental Health at the VA Palo Alto
Health Care System, and Professor of Psychiatry at Stanford University. Over the past 20 years, he has
conducted several studies in sleep and insomnia. He is also Director of the VA Mental Illness Research,
Education, and Clinical Center (MIRECC) at VA Palo Alto Health Care System, and Professor of
Psychiatry at Stanford University School of Medicine. Dr. Yesavage has tremendous experience in the
design and conduct of similar studies. Dr. Yesavage will be involved in the design, execution, and analysis
of this study, and will have the resources of the WRIISC to draw upon as needed.
Andrea Goldstein-Piekarski PhD is a cognitive psychologist and neuroscientist who has been studying sleep
and mental health for over 8 years. As a graduate student she conducted a series of multi- dimensional
studies investigating the impact of sleep loss on anxiety and affective brain function. These investigations
were conducted using a combination of high-density EEG sleep recording, advanced functional and
structural MRI methods, and emotion reactivity paradigms. As a postdoctoral fellow she used advanced
computational modeling to understand the neurobiology contributing to anxiety and mood disorder
symptomology as well as treatment response. Dr. Goldstein-Piekarski will be involved in the design,
execution, and analysis of this study, and will have the resources of the WRIISC to draw upon as needed.
Art Noda, Data Manager. has 25 years of experience of doing data management and analysis for clinical
studies. He has used Statistical Analysis System (SAS, Cary N.C.) software for database management,
programming and data analysis for 18 years. He has developed advanced skills using SAS in database
construction and management as well as proficiency in a variety of complex statistical analyses. Currently
he is supporting various investigators on issues related to data management, security, analysis and
presentation at VAPAHCS. In the current project, he will design and implement a database for the secure
storage of all study-related data, consult on all statistical examinations of the data set, and assist with
presentations and manuscript preparation.
Donn Posner, PhD brings a wealth of knowledge and research experience in behavioral approaches to sleep
treatment adherence and lifestyle modification. Dr. Posner will provide input to Dr. Friedman regarding
the CBT-OSA manual and related materials. Dr. Posner will be available to advise the Project Study
Coordinator regarding individual participant eligibility.
Laura C. Lazzeroni, PhD has collaborated with Dr. Yesavage for the past five years, with a research focus
on statistical genetics and other biostatistical issues, such as multiple hypothesis testing and simultaneous
inference.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 7 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Bea Hernandez, works closely with Dr. Lazzeroni and Art Noda to help with database management and data
analysis.
Grace Fischer is an administrative assistant who will be helping manage the regulatory aspects of the study.
b)
Training.
Describe the training you will provide to ensure that all persons assisting with the research are
informed about the protocol and their research-related duties and functions.
All staff have completed all VA- and Stanford-required training in Human Subjects, Good Clinical Practice,
Privacy, and HIPAA, and any required training for specific procedures. All staff have been trained in this
protocol by the Protocol Director. Some staff have also worked with similar protocols, and all staff
members are very familiar with procedures for this study. Any new staff who join the project will take all
required training before beginning work on the project, and will be carefully trained on all necessary aspects
of the protocol by the Protocol Director or a senior research associate who supervises staff for this project.
Data privacy and proper specimen collection procedures will be stressed before subject contact is allowed.
c)
Facilities.
Provide the location(s) where the research will be conducted, including physical address if not
conducted on site at Stanford University, Stanford Hospital on Pasteur Dr., Lucile Packard Children's
Hospital on Welch Rd. or VAPAHCS. Describe the facilities and resources available to conduct the
research at these sites.
The project will take place at the MIRECC / WRIISC (Mental Illness Research, Education, and Clinical
Center / War-Related Illness and Injury Center) offices,, located at VA Palo Alto Health Care System, Palo
Alto Division. Private interview rooms and a large conference room are available for this project, as well as
office space for staff.
d)
Sufficient time.
Explain the time that you and your research team will allocate to perform the research activities,
including data analysis.
We will have sufficient time to conduct and complete the research. Each of the investigators has sufficient
time available to conduct their part of the research.
Each participant will spend a maximum of 50 weeks in the project.
We expect to begin recruitment in late summer/fall, 2017.
The project will be completed in 5 years.
e)
Access to target population.
Explain and justify whether you will have access to a population that will allow recruitment of the
required number of participants.
Veterans will be recruited and treated at the three VA WRIISCs that are the normal clinical referral sources
for Gulf War Veterans.
f)
Access to resources if needed as a consequence of the research.
State whether you have medical or psychological resources available that participants might require as
a consequence of the research when applicable. Please describe these resources.
Participants will be informed of risks, using the text provided and required by the governing Institutional
Review Boards. Our individual screening and test sessions will be 3 to 4 hours each at the most. In the
event of discomfort experienced during the psychiatric screening and/or cognitive testing, all participants
will be informed that they are free to decline to answer any questions they don't wish to answer, or to stop
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 8 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

the interview or testing at any time. Staff will be well-trained and supervised under the direction of
experienced clinical researchers. Interviews are done at the VA Palo Alto, in the MIRECC/WRIISC offices.
Assistance is available from on-site clinical psychologists and psychiatrists if needed.
g)
Lead Investigator or Coordinating Institution in Multi-site Study.
Please explain (i) your role in coordinating the studies, (ii) procedures for routine communication with
other sites, (iii) documentation of routine communications with other sites, (iv) planned management of
communication of adverse outcomes, unexpected problems involving risk to participants or others,
protocol modifications or interim findings.
The VA Palo Alto site will serve as the lead site for this study, and will host the RedCap database
containing all study data. All samples will be sent to VA Palo Alto, where they will be stored and analyzed.
Data analysis will be done at VA Palo Alto. All therapists will be trained by the study therapist at VA Palo
Alto.
1. Purpose
a)
In layperson's language state the purpose of the study in 3-5 sentences.
The purpose of this study is to evaluate the efficacy and effectiveness of sleep restriction (SR) and cognitive
therapy (CT) in Gulf War Veterans with insomnia.
b)
State what the Investigator(s) hope to learn from the study. Include an assessment of the importance of
this new knowledge.
The primary hypothesis is that the efficacy of these treatments will
depend upon an individual subject's baseline characteristics. For SR
we expect that baseline measures of "excessive time spent in bed" may
predict response and for CT we expect that baseline measures of cognitive arousal and pain may predict
response. Exploratory analyses using signal detection techniques will systematically compare and contrast
the potential usefulness of a number of additional potential moderator measures. Insomnia is a serious
health problem in Gulf War Veterans that is often associated with extensive prescription of sleeping
medications. Although safer, even the latest "sleeping pills" can lead to cognitive impairment and risk of
abuse. Thus non-pharmacological treatments for insomnia have been pursued as
alternatives to medications. Cognitive Behavior Therapy for Insomnia
(CBT-I) is the term widely used to describe therapies that combine behavioral and cognitive therapies for
insomnia. The combined CBT-I approach has well-documented efficacy. Between 2012 and 2014 over 650
VA mental health clinicians have received extensive training in CBT-I. Although CBT-I is efficacious, the
optimal target populations for its major components has not yet been well-defined for Gulf War Veterans.
We propose to address this gap and develop tools for clinicians to identify the best treatment for insomnia
for individual Gulf War Veterans.
c)
Explain why human subjects must be used for this project. (i.e. purpose of study is to test efficacy of
investigational device in individuals with specific condition; purpose of study is to examine specific
behavioral traits in humans in classroom or other environment)
This is a study of insomnia in humans.
2. Study Procedures
a)
Please SUMMARIZE the research procedures, screening through closeout, which the research
participant will undergo. Sections in the protocol attached in section 16 can be referenced, BUT do not
copy the clinical protocol. Be clear on what is to be done for research and what is part of standard of
care. For research involving collaborators, please specify the respective roles of Stanford and each
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 9 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

collaborator on the protocol.
Our hypotheses will be tested in a randomized parallel groups design.
Randomization will be based on type of treatment assignment: either
to SR or CT.
After screening and randomization in the 2-week baseline phase,
subjects will receive SR or CT in the 6-week treatment phase.
Participants will have the option to complete study sessions over
telehealth for the entirety of the 6 weeks. There will be no more
treatment after this point. At the end of the 6-week treatment,
subjects will return to repeat many of the psychological tests
administered during baseline to determine the short-term benefit.
This 4-year proposal will include 100 subjects (2 groups of 50 each) with outcome, mediator and moderator
measures collected at appropriate
points.
All subjects will receive education about basic sleep hygiene as well
as information about the science of sleep including sleep stages and
sleep regulation.
Sleep Restriction Therapy (SR). The initial Time in Bed (TIB)
prescription is calculated on the average total sleep time (TST)
reported in the baseline sleep logs.
After one week, depending on subject's daily sleep logs, the
therapist suggests a new TIB prescription. Napping is neither
prescribed nor proscribed. However, if subjects find themselves very
sleepy (not just tired, but actually sleepy) they are advised to take
a
brief (15 to 30 minutes) nap to ensure their safety.
Cognitive Therapy (CT). The CT treatment module is designed to meet
three general goals:
1) identification of dysfunctional sleep cognitions, 2) challenging
their validity, and 3) replacing them with more adaptive substitutes.
Several specific techniques designed to meet these goals are
discussed
in materials distributed to subjects. Similar to SR, subjects in CT
are given information about relevant elements of the science of sleep and healthy sleep practices.
We will also continue to monitor progress post-treatment in the
follow-up period. The complete package of outcome measures will be repeated at the follow-up session.
We will tell subjects that we expect the benefits of treatment to continue and/or improve with time and we
will also encourage subjects to continue practicing the treatment instructions to maintain their progress after
active treatment ends.
Subjects will be screened for eligibility via a phone interview and
an in person or telehealth evaluation. Subjects that learn about the
study through StudyPages campaign ads and are recruited through the
study landing page developed by StudyPages. They will complete a
brief pre-screening survey to confirm interest and screen for initial
inclusion criteria before being contacted by our study team for a
full phone interview. The in-person or telehealth
evaluation may be split into two visits if necessary.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 10 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

At the in-person or telehealth evaluation, after signing a consent
form, a more detailed interview about sleep problems, and medical and
psychiatric history will be obtained by the Duke Structured Sleep
Interview, including evaluations of cognitive impairment and
depression. Exclusion criteria will further be evaluated by the
following given solely at the office evaluation: Acute/Unstable
Chronic Illness checklist, Columbia Suicide Severity Rating Scale (C-SSRS), DUKE Structured Sleep
Interview, Hamilton Depression Rating Scale (HDRS24), Life Stressor Checklist, Mini International
Neuropsychiatric Interview Version 5 (MINI), Montreal Cognitive Assessment (MOCA) or MOCA-Blind,
Morningness-Eveningness Questionnaire, and the Sleep Related Behavior Questionnaire. Subjects will
additionally be set up with PSG equipment. The PSG will be completed in the subject's own home and be
used to screen a for Obstructive Sleep Apnea and Periodic Limb Movement Disorder.
Subjects will return to the lab the next morning to have the
equipment removed.
Participants will be evaluated on the Anxiety and Preoccupation about
Sleep Questionnaire (APSQ), Depression Anxiety and Stress Scale
(DASS-21), Epworth Sleepiness Scale, and the Insomnia Severity Index each visit during weeks 1-8, and
again at week 32. Sleep logs will be done daily during weeks 1-8, and again at week 32. The following will
be done at weeks 1, 8, and 32: AUA8 Noctoria; Brief Pain Inventory short form (BPI-SF); Beck Anxiety
Inventory (BAI); Beck Depression
Inventory (BDI); Clinician Administered PTSD Scale (CAPS); Dysfunctional Beliefs and Attitudes about
Sleep Scale; AUA8 (DBAS); Glasgow Content of Thoughts; Glasgow Sleep Effort Scale; Multidimensional
fatigue Inventory; Penn State Worry Questionnaire (PSWQ); Perceived Stress Scale (PSS); SF-36 (RAND).
Subjects will be evaluated on Functional Outcomes of Sleep
Questionnaire at weeks 1, 2, 8 and 32.
Subjects will be evaluated on the Sleep Associated Monitoring Index
(SAMI) at weeks 1 and 8.
Subjects will be evaluated on the Trial Making Test, Color Word
Interference test, Thought Control Questionnaire Insomnia-Revised
(TCQI), and the RBANS at weeks 1 and 32.
Following the completion of treatment at week 7, subjects will
complete the Treatment Adherence Survey, Treatment Satisfaction Survey and Working Alliance Inventory.
The Working Alliance Inventory will also be given at the second treatment session (week 3). If participants
are participating in Telehealth, they will complete these questionnaires as RedCap surveys on Stanford's
RedCap.
Blood will be drawn to measure levels of C-reactive protein (CRP).
Urine samples will be collected at during each of the 3 study phases
to monitor abstain from drugs of abuse, except for medical marijuana
used less than four times a week. Samples will be collected by nurses at the VA Clinical Studies Unit and
analyzed by the VA lab. Blood samples will be taken at the same time to be analyzed for C-reactive protein.
Remaining blood will be banked to be analyzed for genetic factors.
Due to the COVID-19 pandemic, we are adding the option for
participants to complete all study sessions through telehealth. We will utilize Zoom and send questionnaires
as RedCap surveys on Stanford's RedCap. This will allow the participants to move forward in the study
while also not deviating from the study timeline. We will still collect adverse events and study measures at
each treatment session. After the COVID-19 shut-down is over, we will still offer telehealth as an option to
our veterans to be flexible to their scheduling needs and keep consistency with the measures taken during
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 11 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

this crisis. Under normal circumstances, we will allow the veterans to choose if they would like to utilize
telehealth or in-person treatment session and would complete all therapy sessions through the selected
delivery method. We will document each individual who started therapy sessions in-person and switched to
telehealth so that we can do analyses to see if their data is viable.
Additionally, we are adding the option for veterans to do their
screening, baseline, and follow-up sessions via telehealth. For these
individuals, we will not collect the following measures: urine
screen, blood draw, Trial Making Test, Color Word Interference test, and overnight PSG (currently only
available at Palo Alto). All other
measures can feasibly be done through telehealth. As stated above, we
will continue to offer this option for the remainder of the study.
Palo Alto will be the main site for virtual national recruitment. We
will recruit participants nationally and also take referrals from the
other sites. If the other sites have a waitlist or are unable to
screen new participants, they will refer the participants to the Palo Alto site to be consented and screened at
our site. The Palo Alto site
will not share PHI with any other sites. The Washington, DC WRIISC site will share PHI (name, mailing
address, phone number) with the Palo Alto site if the participant consents to this. These data will be shared
via an encrypted AZURE email between VA email addresses from the Washington, DC WRIISC study
team to a study team member working at the Palo Alto VA. The Palo Alto site would then call the
participant to complete the phone screen. The other sites can also refer participants to our site by giving the
participants our recruitment flyer/phone number and having the participant call our site or through warm
transfers. If a warm transfer is being conducted, no PHI will be shared prior to this call. The other site will
call the participant and ask if they would like to participate at our site or remain on their site's waitlist. If
they would like to be transferred, a lab member from our site will be added to the telephone call and then
left with the participant to complete the telephone screen.
b)
Explain how the above research procedures are the least risky that can be performed consistent with
sound research design.
There is little risk to the proposed procedures.
c)
State if deception will be used. If so, provide the rationale and describe debriefing procedures. Since
you will not be fully informing the participant in your consent process and form, complete an
alteration of consent (in section 13). Submit a debriefing script (in section 16).
No deception will be used.
d)
State if photo, audio or video recording will occur. Describe what will become of the photos or
recording after use, e.g., shown at scientific meetings, erased. Describe the final disposition of the
recordings.
Audio recordings will be done for quality control purposes. All
recordings will be stored in locked cabinets and destroyed at the end
of the VA-required holding period (currently 6 years). Sessions done
through telehealth will have audio and video recorded.
e)
Describe alternative procedures or courses of treatment, if any, that might be advantageous to the
participant. Describe potential risks and benefits associated with these. Any standard treatment that is
being withheld must be disclosed in the consent process and form. (i.e. standard-of-care drug, different
interventional procedure, no procedure or treatment, palliative care, other research studies).
Alternate treatments for insomnia include various medications and
other
behavioral treatments. An alternative is not to participate.
f)
Will it be possible to continue the more (most) appropriate therapy for the participant(s) after the
conclusion of the study?
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 12 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

The study treatments are forms of learning or training. Participants
should be able to continue on their own if they find the treatment
useful, they will be given didactic material that they can refer to
after the treatment is over. Cognitive Behavioral Therapy is
available
from clinicians and therapists at VA hospitals and in most
communities.
g)
Study Endpoint. What are the guidelines or end points by which you can evaluate the different
treatments (i.e. study drug, device, procedure) during the study? If one proves to be clearly more
effective than another (or others) during the course of a study, will the study be terminated before the
projected total participant population has been enrolled? When will the study end if no important
differences are detected?
The study is expected to continue until all participants have
completed
the procedures.
3. Background
a)
Describe past experimental and/or clinical findings leading to the formulation of the study.
Insomnia in Veterans is a serious problem often associated with
extensive
prescription of sleeping medications.
Although safer, even the latest "sleeping pills" are not without
risks.
Lack
of safe and effective treatment for insomnia has notable economic
impact
on
society and patients alike. Thus, nonpharmacological treatments for
insomnia
have been pursued as alternatives to medications with some suggesting
they
should be the "first line of therapy". In two studies published in
1998
the
prevalence of insomnia in GWVs was 30 and 31% compared to 11% in
Veterans
deployed to Germany during the same period. Of particular import is a
2014
study performed by colleagues at our VISN21 MIRECC documenting poor
sleep
quality in GWVs twenty years after deployment. This study found that
sleep
disturbance was also associated with abnormalities in brain volume.
Finally,
Gehrman and associates have documented that insomnia is a serious
problem
for many Veterans and is associated with medical and psychiatric
comorbidities other than those problems related with over-medication.
Cognitive Behavior Therapy for Insomnia (CBT-I) is the term widely
used
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 13 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

to
describe psychological therapies that combine a broad range of non-
pharmacological treatments for insomnia. The combined CBT-I approach
has
well-documented efficacy. Under the direction of the VISN 21 MIRECC,
over
650 VA mental health clinicians have completed extensive training in
CBT-
I.
Components of CBT-I may include behavioral interventions (e.g.,
stimulus
control, sleep restriction, relaxation training), cognitive therapy,
and
sleep hygiene education. Stimulus control is based on the concept
that
following a set of instructions will re-associate the bed and bedroom
with
sleep and reestablish a consistent sleep/wake pattern.
Sleep restriction (SR) is designed to reduce "excessive time spent in
bed"
to the actual amount of the subject's sleep time, thereby increasing
sleep
pressure that leads to higher quality sleep. Cognitive therapy (CT)
for
insomnia, like CT for other disorders, focuses on changing
maladaptive
cognitions, intrusive thoughts and perception of pain that interfere
with
sleep. Harvey et al. suggest that a broad range of cognitive
processes
such
as beliefs, attributions, and expectations are relevant to
understanding
insomnia. CT challenges maladaptive and/or inaccurate cognitions
about
sleep
and insomnia. CBT-I combines CT with one or more of the behavioral
therapies. Both SR and CT include a sleep education component that
provides
an understanding of basic sleep regulation and sleep hygiene
instructions.
Background to Insomnia Treatments in Gulf War Veterans. A National
Academy
of Sciences Workgroup has recognized insomnia in Gulf War Veterans to
be
associated with Chronic Multisymptom Illness (CMI). CBT-I is
recognized
to
be a "Best Practices" recommendation for the treatment of insomnia
associated with CMI. Although this Workgroup identifies several pain
syndromes associated with Gulf War syndrome, their extensive
literature
review did not discover any studies discussing the comorbidity of
pain
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 14 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

syndromes with insomnia in Gulf War Veterans.
Nonetheless, the appended CBT-I manual used in current training of VA
therapists specifically addresses CT strategies for dealing with pain
syndromes including those seen in Gulf War Veterans. Similar
strategies
have
been used in the past to treat insomnia in patients with fibromyalgia
and
other syndromes with chronic pain. In sum, there is little data on
how
pain
experienced by Gulf War Veterans may affect their response to
treatments
for
insomnia.
Gaps in the Literature of Insomnia Treatments in Gulf War Veterans to
be
Addressed by the Proposed Research. It is unknown how chronic pain
associated with CMI might affect outcome from either SR or CT.
Although
CBT-
I has well-documented efficacy and is recommended for use in Gulf War
Veterans, the optimal target populations for the SR or CT components
has
not
been well-defined for this cohort. We propose to address this gap
with
the
research described here. Such knowledge, could lead to rational
allocation
of resources and not waste either patient or therapist time applying
interventions that are not likely to be of benefit.
b)
Describe any animal experimentation and findings leading to the formulation of the study.
not applicable.
4. Radioisotopes or Radiation Machines
a)
List all standard of care procedures using ionizing radiation (radiation dose received by a subject that
is considered part of their normal medical care). List all research procedures using ionizing radiation
(procedures performed due to participation in this study that is not considered part of their normal
medical care). List each potential procedure in the sequence that it would normally occur during the
entire study. More Info
Identify Week/Month of study
Name of Exam
Identify if SOC or Research
b)
For research radioisotope projects, provide the following radiation-related information:
Identify the radionuclide(s) and chemical form(s).
For the typical subject, provide the total number of times the radioisotope and activity will be
administered (mCi) and the route of administration.
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PD: Jerome A Yesavage
APPLICATION FORM
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Review Type: Regular
Human Subjects Research
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Predictors of Response to Insomnia Treatments for Gulf War Veterans
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If not FDA approved provide dosimetry information and reference the source documents (package
insert, MIRD calculation, peer reviewed literature).
c)
For research radiation machine projects, provide the following diagnostic procedures:
For well-established radiographic procedures describe the exam.
For the typical subject, identify the total number of times each will be performed on a single
research subject.
For each radiographic procedure, provide the setup and technique sufficient to permit research
subject dose modeling. The chief technologist can usually provide this information.
For radiographic procedures not well-established, provide FDA status of the machine, and
information sufficient to permit research subject dose modeling.
d)
For research radiation machine projects, provide the following therapeutic procedures:
For a well-established therapeutic procedure, identify the area treated, dose per fraction and
number of fractions. State whether the therapeutic procedure is being performed as a normal part of
clinical management for the research participants's medical condition or whether it is being
performed because the research participant is participating in this project.
For a therapeutic procedure that is not well-established, provide FDA status of the machine, basis
for dosimetry, area treated, dose per fraction and number of fractions.
5. Devices
a) Please list in the table below all Investigational Devices (including Commercial Devices used off-label) if
they are being studied.
b) Please list in the table below all IDE Exempt Devices (Commercial Device used according to label,
Investigational In Vitro Device or Assay, or Consumer Preference/Modifications/Combinations of
Approved Devices) to be used on participants.
5. 1
Device Name :
Compumedics Safiro? ambulatory PSG system
Describe the device to be used.
We will use the Compumedics Safiro? ambulatory PSG system. This includes monitoring of the
electroencephalogram (EEG; C3-A2 or C4-A1, O2-A1 or O1-A2), electrooculogram (EOG; ROC-A1,
LOC-A2), chin and anterior tibialis electromyograms (EMG), heart rate by two-lead EKG, snoring
intensity (anterior neck microphone), nasal pressure (nasal cannula), thoracic and abdominal
movement (inductance plethysmography bands), and oxygen saturation (pulse oximetry).
Manufacturer
Compumedics
IDE Exemption
Y
This is a legally marketed device being used in accordance with its labeling.
6. Drugs, Reagents, or Chemicals and Devices
a) Please list in the table below all investigational drugs, reagents or chemicals if they are being studied.
Protocol # 38548 ( Continuing Review )
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PD: Jerome A Yesavage
APPLICATION FORM
Page 16 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

b) Please list in the table below all commercial drugs, reagents or chemicals if they are being studied.
7. Medical Equipment for Human Subjects and Laboratory Animals
If medical equipment used for human patients/participants is also used on animals, describe such
equipment and disinfection procedures.
No equipment is used on animals.
8. Participant Population
a)
State the following: (i) the number of participants expected to be enrolled at Stanford-affiliated site(s);
(ii)the total number of participants expected to enroll at all sites; (iii) the type of participants (i.e.
students, patients with certain cancer, patients with certain cardiac condition) and the reasons for
using such participants.
Please note: Our original targets changed due to COVID-19 as a result of the pandemic we are no longer
expecting to meet the full recruitment target.
(i) We plan to randomize and enroll 20-25 participants at the VA Palo Alto Health Care Systems, a
Stanford-affiliated site. We plan to consent 50-60 participants total to adjust for the attrition rate of 36%
(20/.36 = 55.6).
(ii) A total of 50-55 subjects are expected across all sites. There are 3 sites, at WRIISC California, located
at VA Palo Alto, WRIISC New Jersey, located at VA New Jersey, and at WRIISC Washington DC, at
Washington DC VA. Since the study will now have a telehealth option, the study will be open to veterans
across the country.
(iii) Participants will be Gulf War Veterans with insomnia.
b)
State the age range, gender, and ethnic background of the participant population being recruited.
Age Range: we expect the ages of gulf war veterans to be within the ages of 42-80.
Gender: Males and Females
Ethnic Background: Any race or ethnic origin
c)
State the number and rationale for involvement of potentially vulnerable subjects in the study
(including children, pregnant women, economically and educationally disadvantaged, decisionally
impaired, homeless people, employees and students). Specify the measures being taken to minimize the
risks and the chance of harm to the potentially vulnerable subjects and the additional safeguards that
have been included in the protocol to protect their rights and welfare.
Children, pregnant women, economically and educationally disadvantaged, decisionally impaired, and
homeless people will not be recruited for this protocol.
d)
If women, minorities, non-English speaking individuals, or children are not included, a clear
compelling rationale must be provided (e.g., disease does not occur in children, drug or device would
interfere with normal growth and development, etc.).
There will be no participation of children in this study.
The research topic to be studied is irrelevant to children because we are studying military Veterans of the
Gulf War.
e)
State the number, if any, of participants who are laboratory personnel, employees, and/or students.
They should render the same written informed consent. If payment is allowed, they should also receive
it. Please see Stanford University policy.
It is unlikely that any laboratory personnel, employees, or students will qualify for participation in this
study. If any do qualify and wish to participate, they will be treated the same as any other participant.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 17 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

f)
State the number, if any, of participants who are healthy volunteers. Provide rationale for the
inclusion of healthy volunteers in this study. Specify any risks to which participants may possibly be
exposed. Specify the measures being taken to minimize the risks and the chance of harm to the
volunteers and the additional safeguards that have been included in the protocol to protect their rights
and welfare.
Participants should all be in fair to good physical health.
g)
Describe your plan to identify and recruit potential participants including who will inform them about
the study and how they will be initially contacted by the researchers (e.g., Research Engagement
services; chart review; treating physician; ads including social media posts). All final or revised
recruitment materials must be approved by the IRB before use. Contacting potential participants is
not permitted prior to IRB approval. See Recruitment Guidance for additional information.
Veterans will be recruited and treated at the three WRIISCs that are the normal clinical referral sources for
Gulf War Veterans, through chart reviews, and through articles in local newspapers, relevant newsletters,
flyers, and online forums such as reddit, facebook and craigslist. We will also use the DMDC recruitment
database, WRIISC database, and the Gulf War Registry Database to identify potential participants. We will
send letters and call possible participants from these three databases.
Participants will be recruited nationally at the Palo Alto site.
If the other sites have a waitlist, they will refer participants to participate in the study virtually at Palo Alto.
They will be screened and consented at Palo Alto. The other sites can refer participants to our site by giving
the participants our recruitment flyer/phone number and having the participant call our site or through warm
transfers. Before the warm transfer, no PHI will be shared. The other site will call the participant and ask if
they would like to participate at our site or remain on their site's waitlist. If they would like to be transferred,
a lab member from our site will be added to the telephone call and then left with the participant to complete
the telephone screen. The Palo Alto site will not share PHI with any other sites. The Washington, DC
WRIISC site will share PHI (name, mailing address, phone number) with the Palo Alto site if the participant
consents to this. These data will be shared via an encrypted AZURE email between VA email addresses
from the Washington, DC WRIISC study team to a study team member working at the Palo Alto VA. The
Palo Alto site would then call the participant to complete the phone screen.
Veterans will also be recruited through the StudyPages outreach campaign that will utilize a targeted social
media campaign through Facebook. Interested participants can be redirected to the study landing page if
they click on the links on the campaign ads. We will call possible participants using the phone number they
provide through the pre-screening survey if they agree to share their information in order to be contacted
about the study.
h)
Inclusion and Exclusion Criteria.
Identify inclusion criteria.
o Male or female Gulf War Veterans of any racial or ethnic group
o Independent Living (not in nursing home or VA Extended Care facility)
o Subjective complaint of insomnia on the Insomnia Severity Index (ISI) ≥10
o Subjects with PTSD will be included in this study as long as they do not meet criteria for depression
described below.
o Use of CNS active medications that could significantly impact sleep or alertness is allowed as long as the
dose, timing, and formulation are stable (≥3 weeks).
o Stable adult onset diabetes, controlled with insulin, oral medications or diet is acceptable.
o Access to a device with video capabilities and ability to have the video on during study visits
Identify exclusion criteria.
o Sleep-Related
• Excessive caffeine consumption (≥4 cups of coffee per day) and unable to reduce to ≤3 cups before
lunch a day for ≥3 weeks prior to treatment.
• Subjects will be initially screened by the Berlin Questionnaire (for sleep apnea) and those with
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 18 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

responses suggestive of high risk for sleep apnea, will be referred to Pulmonary Medicine for standard
clinical screening including polysomnography. Those in which apnea is primarily responsible for their sleep
complaints should be excluded.
• Subjects working a rotating shift or an unconventional daytime shift (ending after 1830 h, expected to be
rare in the age group we are studying) will be ineligible.
• Subjects who have received CBT-I treatment within the past year will also be excluded due to potential
carry over effects to the current treatment.
o Neuropsychiatric
• Hamilton Depression Scale (HDRS ≥24) and classified as high risk on the Columbia Suicide Severity
Scale (C-SSRS) in the past month. Individuals are considered high risk if they have endorsement of either of
the following on the C-SSRS:
a) A positive endorsement, relative to the past 30 days, in the "Suicide Thoughts" section of item #4 (Have
you had these thoughts and had some intention of acting on them) or item #5 (Have you started to work out
or worked out the details of how to kill yourself? Do you intend to carry out this plan?
b) A positive endorsement, relative to the past 90 days, in the "Suicide Behavior" section of item #6 (Have
you ever done anything, started to do anything, or prepared to do anything to end your life?)
• Current or lifetime history of a psychiatric disorder with primary psychotic features.
• Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation.
• Current exposure to trauma, or exposure to trauma in the past 3 months.
• Current or within the past 30 days: drug abuse or dependence (except nicotine).
• Current or expected cognitive behavior therapy for another condition (e.g. depression).
• Excessive alcohol consumption (>14 drinks per week or > 4 drinks per occasion)
• Presence of any acute or unstable psychiatric condition(s) that requires referral for treatment.
• Montreal Cognitive Assessment (MOCA) < 20 or Montreal Cognitive Assessment
Blind(MOCA-BLIND) < 15.
o Medical
• Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney,
prostate or bladder conditions causing excessively frequent urination (> 3 times per night); medically
unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen
changes in the prior 3 months; stroke with serious sequelae; cancer if < 1 year since end of treatment;
asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological
disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment
regimen changes in the prior 3 months. Unstable adult onset diabetes will be excluded.
i)
Describe your screening procedures, including how qualifying laboratory values will be obtained. If
you are collecting personal health information prior to enrollment (e.g., telephone screening), please
request a waiver of authorization for recruitment (in section 15).
StudyPages Prescreening: Consent to complete the pre-screening survey will be obtained electronically on
the survey through the study landing page. Interested subject will reach the study landing page by clicking
the link on the StudyPages online posting/advertisements. The study landing page will contain a description
of the study purpose, procedures, requirements, and study staff contact information. Interested subjects will
need to select the "See if you may qualify" button on the study landing page so that the initial prescreening
survey prompt box appears which will instruct subjects that they should call the clinical coordinators using
the study phone number if they have any questions and review the consent and HIPAA information for the
prescreening survey questions, and then that by clicking "Next" on the pre-screening survey, they are i)
consenting to participate in the pre-screening questionnaire, ii) agreeing with the information they read
regarding the prescreen survey and how their information will be used/protected, iii) agreeing to proceed to
the prescreening questions, and iv) that all of their information is confidential. Interested subjects will only
be able to proceed if they click "Next" after reviewing the consent form information before the next page
appears that allows them to respond to the prescreening questions (included in the StudyPages document in
section 16). Upon completion an successful submission of their responses, subjects will be notified that the
study team will reach out to them regarding their eligibility. The study team will then review the
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APPLICATION FORM
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Review Type: Regular
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Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

prescreening responses and call interested subjects and follow the screening procedures listed below.
Respondents will be given a brief description of study procedures and research goals. If respondents are
interested, the interviewer will ask further questions regarding current symptoms and medical histories to
determine if we should proceed to an in-person screening evaluation.
Subjects will be screened for eligibility via a phone interview and an in person or telehealth evaluation. The
in-person or telehealth evaluation may be split into two visits if necessary. At the in-person or telehealth
evaluation, after signing a consent form, a more detailed interview about sleep problems, and medical and
psychiatric history will be obtained by the Duke Structured Sleep Interview, including evaluations of
cognitive impairment and depression. Exclusion criteria will further be evaluated by the following given
solely at the office evaluation: Berlin Questionnaire, Life Stressor Checklist, Columbia Suicide Severity
Rating Scale (C-SSRS), Acute/Unstable Chronic Illness checklist, Mini International Neuropsychiatric
Interview Version 5 (MINI), Morningness-Eveningness Questionnaire, Montreal Cognitive Assessment
(MOCA) or MOCA-Blind, Thought Control Questionnaire Insomnia-Revised (TCQI), and the Mini-Mental
State Exam (MMSE). If the session is conducted in-person, subjects will additionally be set up with PSG
equipment. The PSG will be completed in the subject's own home and be used to screen for Obstructive
Sleep Apnea and Periodic Limb Movement Disorder. Subjects will return to the lab the next morning to
have the equipment removed.
At that time a brief physical exam will be conducted including cardiopulmonary and neurological status.
Potential subjects will complete 1 week of daily sleep logs, which will serve as a further screening to insure
that subjects' insomnia severity meets our entry criteria. Baseline sleep logs will also serve to screen for
certain disorders such as a non-24-h sleep-wake syndrome or an irregular sleep-wake pattern (i.e., ≥3 sleep
episodes during a 24-h period indicating an absence of a circadian rhythm). Potential participants will also
undergo relevant psychological tests, and medical, psychiatric, and medication histories will be gathered
and evaluated. Subjects taking sleeping medications at the time of recruitment will be admitted to the study
if under the supervision of their physician they remain stable on the medication for a minimum of 3 weeks
before acceptance into the protocol.
Participants who complete a screening session via telehealth will not undergo a physical but will complete
all other screening measures.
Participants from other sites can be referred to Palo Alto for screening. They will be given our phone
number and told to contact us. We will follow the remote screening procedures outlines above for these
participants.
j)
Describe how you will be cognizant of other protocols in which participants might be enrolled. Please
explain if participants will be enrolled in more than one study.
We will ask the potential subject if they are participating in any other protocols, and document this on the
consent form. They will be instructed not to participate in any other protocols during their involvement
with our study without first getting prior authorization from both our research team and that of the other
study. Overlapping participation will be handled on a case-by-case basis.
k)
Payment/reimbursement. Explain the amount and schedule of payment or reimbursement, if any, that
will be paid for participation in the study. Substantiate that proposed payments are reasonable and
commensurate with the expected contributions of participants and that they do not constitute undue
pressure on participants to volunteer for the research study. Include provisions for prorating payment.
See payment considerations
Participants will receive $150 for the screening procedures including the PSG. If the participant is
determined to be eligible for the study, s/he will receive stipends of $25 for each of the 6 treatment visits
thereafter and $25 for the follow up visit 7 x $25 = $175. Participants who complete all treatment visits and
the follow up, which includes a second PSG overnight, visit will receive a $150 completion bonus. Thus,
participants who complete all the study visits will receive a total of $475.
If a participant completes the study through telehealth, they will receive $50 for the screening procedures.
If the participant is determined to be eligible for the study, s/he will receive stipends of $25 for all 6
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PD: Jerome A Yesavage
APPLICATION FORM
Page 20 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

treatment visits thereafter and $25 for the follow up visit (7 x $25 = $175). Participants who complete all
treatment visits and the follow up visit will receive a $50 completion bonus
These stipends are intended to encourage compliance with the research protocol without adding undue
influence.
l)
Costs. Please explain any costs that will be charged to the participant.
No costs to the subject will arise as a result of participation in this study, other than transportation to and
from the Center, and the time involved.
m)
Estimate the probable duration of the entire study. Also estimate the total time per participant for: (i)
screening of participant; (ii) active participation in study; (iii) analysis of participant data.
The entire study should take about 4 years.
(i) Screening for each participant will take approximately 5 hours
(ii) Each participant will actively participate in the study for approximately 32 weeks.
(iii) Analysis of participant data is taking longer than anticipated and will estimate an additional 12 to
24 months for data analysis to be completed at this time.
9. Risks
a) For the following categories include a scientific estimate of the frequency, severity, and reversibility of potential
risks. Wherever possible, include statistical incidence of complications and the mortality rate of proposed
procedures. Where there has been insufficient time to accumulate significant data on risk, a statement to this
effect should be included. (In describing these risks in the consent form to the participant it is helpful to use
comparisons which are meaningful to persons unfamiliar with medical terminology.)
i. The risks of the Investigational devices.
Not applicable.
ii. The risks of the Investigational drugs. Information about risks can often be found in the
Investigator's brochure.
Not applicable.
iii. The risks of the Commercially available drugs, reagents or chemicals. Information about risks can
often be found in the package insert.
Ambulatory Overnight Sleep Recording (Compumedics Safiro ambulatory PSG).
The electrodes used for the ambulatory overnight recording have a risk of causing a minor skin irritation
(rash) underneath the electrode. If this were to happen, we will suggest that the subject put normal skin
lotion on the affected area.
EEG recording.
There is little risk to EEG recording. Participants may find the cap annoying or uncomfortable. If this
occurs we will try to make them more comfortable, or stop the procedure if the participant requests.
iv. The risks of the Procedures to be performed. Include all investigational, non-investigational and
non-invasive procedures (e.g., surgery, blood draws, treadmill tests).
Cognitive Therapies. There are virtually no risks involved in the cognitive therapies (CBT and SR). Some
participants may feel sleepy during the Sleep Restriction therapy. They will be instructed to nap if needed.
Cognitive and psychosocial testing. There are virtually no risks involved in the cognitive testing and
psychosocial measurements other than the anxiety that can be associated with any test. Repeated evaluations
of mood and mental status may be slightly frustrating or produce fatigue and boredom.
Sleep Log and Questionnaires. There are no harmful effects to filling out the sleep log and questionnaires,
but some people may find answering the questionnaires annoying or boring.
v. The risks of the Radioisotopes/radiation-producing machines (e.g., X-rays, CT scans, fluoroscopy)
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APPLICATION FORM
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Human Subjects Research
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Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

and associated risks.
Not applicable.
vi. The risks of the Physical well-being.
See above procedures. No other risks to physical well-being are anticipated.
vii. The risks of the Psychological well-being.
From past experience, potential risk to participants is expected to be minimal. Specifically, questions asked
that may be potentially distressing to the participants or may cause them to think about problems relating to
them that may be anxiety-provoking or upsetting.
A psychiatric screening will be performed to determine whether the participant meets inclusion and
exclusion criteria for the study. From past experience, potential risk to participants is expected to be
minimal. Specifically, questions asked may be potentially distressing to the participants or may cause them
to think about problems relating to them that may be anxiety-provoking or upsetting. Patients who develop
suicidal intent will be treated following established procedures at VAPAHCS, Washington DC VA Medical
Center and VA NJ Health Care System.
Cognitive Testing. There do not appear to be any risks associated with cognitive testing other than the
commitment of significant time for participation. Some participants may experience anxiety during and after
the cognitive testing.
Questionnaires. There are virtually no risks involved in filling out our questionnaires, sleep-wake cycle
questionnaires and sleep logs other than the time involved.
viii. The risks of the Economic well-being.
No risks to economic well-being are anticipated.
ix. The risks of the Social well-being.
No risks to social well-being are anticipated.
Overall evaluation of Risk.
Low - innocuous procedures such as phlebotomy, urine or stool collection, no therapeutic agent, or safe
therapeutic agent such as the use of an FDA approved drug or device.
b)
If you are conducting international research, describe the qualifications/preparations that enable you
to both estimate and minimize risks to participants. Provide an explanation as to why the research
must be completed at this location and complete the
[LINKFORINTERNATIONALREASEARCHFORM] International Research Form. If not applicable,
enter N/A.
Not applicable.
c)
Describe the planned procedures for protecting against and minimizing all potential risks. Include the
means for monitoring to detect hazards to the participant (and/or to a potential fetus if applicable).
Include steps to minimize risks to the confidentiality of identifiable information.
Suicidal thoughts. Both the BDI and the Columbia Suicide Severity Rating Scale will be administered to
assess for SI. Any responses to questions that would indicate suicidal thoughts will be referred to the PI (a
psychiatrist) for review and appropriate action as soon as possible. The PI will determine appropriate
immediate action, and the participant will be referred to appropriate therapy.
Before each telehealth session, study staff will collect an emergency contact and the address that the
participant is located. If the clinician deems the participant to be at acute risk of suicide during a risk
assessment and the participant leaves the Zoom session or the clinician cannot contact the participant, they
will reach out to the emergency contact. If the clinician cannot reach the emergency contact, they will call
local emergency services to initiate a welfare check.
We will provide information for contacting the Veterans Crisis Line at the top of each survey page. We have
an alert in RedCap to notify study staff immediately via email if a participant endorses suicidal ideation on a
survey.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 22 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Cognitive testing. If the participant is fatigued or uncomfortable with testing, a break can be taken to rest. If
a participant is unwilling to continue a testing session, they will be given the option of continuing at a later
time, ending the current session, or ending all participation.
Ambulatory Overnight Sleep Recording and EEG. We will make every attempt to attach sensors carefully
so that they provide the minimum discomfort possible.
Data. Paper data with PHI will be kept in locked cabinets and electronic data with PHI will be stored on
physically secure and password protected computers and on the MIRECC/WRIISC server in the PAVA
server room (a locked facility behind the VA firewall). Computer data backups are done by VA IT.
Computers are password protected. Offices are locked when unoccupied.
Sleep Log and Questionnaires. There are no known significant risks associated with completing Sleep Logs
and associated questionnaires.
Venipuncture. Experienced medical personnel will handle all the blood drawing procedures and sterile
conditions will be maintained.
d)
Explain the point at which the experiment will terminate. If appropriate, include the standards for the
termination of the participation of the individual participant Also discuss plans for ensuring necessary
medical or professional intervention in the event of adverse effects to the participants.
The experiment will end at either the normal termination or whenever the subject decides to withdraw from
the study.
e)
Data Safety and Monitoring Plan (DSMP). See guidance on Data Safety and Monitoring.
A Data and Safety Monitoring Plan (DSMP) is required for studies that present Medium or High risk
to participants. (See Overall Evaluation of Risk above). If Low Risk, a DSMP may not be necessary.
Multi-site Phase III clinical trials funded by NIH require the DSM Plan to have a Data Safety
Monitoring Board or Committee (DSMC or DSMB). The FDA recommends that all multi-site clinical
trials that involve interventions that have potential for greater than minimal risk to study participants
also have a DSMB or DSMC.
The role of the DSMC or DSMB is to ensure the safety of participants by analyzing pooled data from
all sites, and to oversee the validity and integrity of the data. Depending on the degree of risk and the
complexity of the protocol, monitoring may be performed by an independent committee, a board
(DSMC/DSMB), a sponsor's Data Safety Committee (DSC), a Medical Monitor, a sponsor's safety
officer, or by the Protocol Director (PD).
Describe the following:
1. What type of data and/or events will be reviewed under the monitoring plan, e.g. adverse events,
protocol deviations, aggregate data?
At each visit, participants will be asked about any adverse events which may have occurred since the last
visit. Information about adverse events (including any injuries, illnesses, hospitalizations, etc.; this
would include any adverse effects on sleep caused by study procedures) is collected at each visit by the
interviewer. Any potentially serious problem is brought immediately to the Principal Investigator for
review.
2. Identify who will be responsible for Data and Safety Monitoring for this study, e.g. Stanford
Cancer Institute DSMC, an independent monitoring committee, the sponsor, Stanford investigators
independent of the study, the PD, or other person(s).
The Protocol Director is the monitoring entity.
3. Provide the scope and composition of the monitoring board, committee, or safety monitor, e.g.,
Protocol # 38548 ( Continuing Review )
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PD: Jerome A Yesavage
APPLICATION FORM
Page 23 of 39
Review Type: Regular
Human Subjects Research
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Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

information about each member's relevant experience or area of expertise. If the Monitor is the
Stanford Cancer Center DSMC or the PD, enter N/A.
n/a
4. Confirm that you will report Serious Adverse Events (SAEs), Suspected Unexpected Serious
Adverse Reactions (SUSARs), or Unanticipated Problems (UPs) to the person or committee
monitoring the study in accordance with Sponsor requirements and FDA regulations.
The Protocol Director will review all Adverse Events and Serious Adverse Events as soon as possible
after the occurrence. SAEs are reported and forwarded to IRB as appropriate.
5. If applicable, how frequently will the Monitoring Committee meet? Will the Monitoring
Committee provide written recommendations about continuing the study to the Sponsor and IRB?
Information about adverse events is collected at each visit by the interviewer. Any potentially serious
problem is brought immediately to the Protocol Director. All data entered into the database is monitored
by the senior research associate and the database manager.
6. Specify triggers or stopping rules that will dictate when the study will end, or when some action
is required. If you specified this in Section 2g [Study Endpoints], earlier in this application enter
'See 2g'.
Criteria for discontinuation of a patient in the study will include an increase in bothersome nightmares
for a week under treatment. We have not seen consistent reporting of nightmares with the proposed
treatments, however that is always possible, hence we would want to make sure that nightmares
occurred for at least a week before a patient was discontinued. Patients will be allowed to continue in the
protocol after an SAE independent of treatment, e.g. hospitalization following a fall. All treatments are
considered active and patients will be allowed to continue their treatment as a courtesy. However, data
from such subjects will not be included in statistical analyses since such SAEs may affect sleep. Patients
will not be restarted if their sleep deteriorates meeting the above criteria and they are discontinued from
the protocol.
7. Indicate to whom the data and safety monitoring person, board, or committee will disseminate
the outcome of the review(s), e.g., to the IRB, the study sponsor, the investigator, or other officials,
as appropriate.
Serious Adverse Events are reported to the IRB using the standard reporting forms.
8. Select One:
Y
The Protocol Director will be the only monitoring entity for this study.
This protocol will utilize a board, committee, or safety monitor as identified in question #2 above.
10. Benefits
a)
Describe the potential benefit(s) to be gained by the participants or by the acquisition of important
knowledge which may benefit future participants, etc.
Some participants may find that their sleep is improved.
11. Privacy and Confidentiality
Privacy Protections
a)
Describe the setting and method (e.g. crowded waiting room, patient exam room, telephone or email
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
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Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

communication) in which interactions will occur and how the privacy interests of participants will be
maintained. Note, high risk data such as PHI must be sent via "Secure:" email per Stanford policy.
During screening, participants will meet in a private interview room
with a member of the study team to sign the consent form, discuss the
protocol, and determine suitability for enrollment. All interviews will
be done in a private setting. Samples will be obtained in a private
setting.
Telehealth sessions will also be private. Study staff will confirm with
each participant that they are in a safe and private location before
beginning each session.
Study staff will use the program AZURE to send secured emails from VA
email addresses to the participant's email.
Confidentiality Protections
b)
Specify PHI (Protected Health Information). PHI is health information linked to HIPAA identifiers
(see above). List BOTH health information AND HIPAA identifiers. If you are using STARR, use the
Data Privacy Attestation to ensure that your request will match your IRB-approved protocol. Be
consistent with information entered in section 15a.
We are collecting the following identifiable information or PHI:
* full name,
* social security number (for VA hospital registration and payment),
* telephone number (for communication),
* mailing address (for appointment notices and to mail payment),
* date of birth (study metric),
* date of visit,
* VA CPRS medical record
* Medical history and physical examination information,
* Demographic information (gender, ethnicity, education, occupation)
* Progress notes,
* Biological specimens (e.g. blood, urine, spinal fluid),
* Diagnostic/Laboratory test results,
* Discharge summary,
* Survey/Questionnaire responses,
* Cognitive and Psychological test results.
*Emergency Contact: name and phone number
c)
You are required to comply with University Policy that states that ALL electronic devices: computers
(laptops and desktops; OFFICE or HOME); smart phones; tablets; external hard disks, USB drives,
etc. that may hold identifiable participant data will be password protected, backed up, and encrypted.
Stanford University IT approved platforms (https://uit.stanford.edu/guide/riskclassifications
https://uit.stanford.edu/guide/riskclassifications) should be used for data management. Consult with
your Department IT representative for more information.For data security policies and links to
encrypt your devices see http://med.stanford.edu/irt/security and
target=_blankhttp://www.stanford.edu/group/security/securecomputing/mobile_devices.html.
Additionally, any PHI data on paper must be secured in a locked environment.
By checking this box, You affirm the aforementioned. Y
Paper data / PHI will be kept in locked file cabinets and electronic
data with PHI will be stored on physically secure and password
protected
computer servers behind a firewall at the VAPAHCS. Computer data
backups
will be stored in locked cabinets.
Computers will be password protected. Laptops and removable hard drives
will be encrypted. The WRIISC is located in a lockable area of Building
Protocol # 38548 ( Continuing Review )
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PD: Jerome A Yesavage
APPLICATION FORM
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Human Subjects Research
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Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
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08/31/2024 - 08/31/2025

5 at the VAPAHCS. Offices are locked when not occupied.
All samples are stored in a locked laboratory at VAPAHCS.
De-identified data are stored internally and are off-loaded to a PC via
a USB cable. Custom software analyzes breathing data and derives AHI,
as
well as apnea and hypopnea indices.
StudyPages is a cloud-based HIPAA compliant SaaS platform. To protect
sensitive information, data at rest is encrypted with 256-bit AES
encryption in the StudyPages Application Database. All data transfer
in/out of the system is encrypted in-transit using 256 bit SSL and all
communications with the StudyPages platform are forced to use HTTPS.
Only the personnel authorized to have access to participant PHI on our
study team will have password protected access to sign up information.
d)
Describe how data or specimens will be labeled (e.g. name, medical record number, study number,
linked coding system) or de-identified. If you are de-identifying data or specimens, who will be
responsible for the de-identification? If x-rays or other digital images are used, explain how and by
whom the images will be de-identified.
Data, specimens, and computer files will be given a code and
information
linking code and PHI will be kept on a secure, password protected
computer behind a firewall. The PI has the code key. The Data Manager
is
responsible for de-identification.
e)
Indicate who will have access to the data or specimens (e.g., research team, sponsors, consultants) and
describe levels of access control (e.g., restricted access for certain persons or groups, access to linked
data or specimens).
Members of the research team will have access to all data. The data
manager has no access to any subject names or contact information. Off-
site collaborators will not have access to PHI or sensitive data.
If the subject requests it explicitly (in writing), we will send
information about certain test results to his/her personal physician.
De-identified data will be shared with collaborating researchers
at Stanford University and at other institutions. De-identified data
may also be shared with collaborating researchers at other institutions
in the future. No names, social security numbers, or other identifying
data will be shared with anyone outside of the research team at VA.
Collaborators at other sites will not have access to PHI from the Palo
Alto site. Palo Alto will receive PHI (name, mailing address, phone
number) from the Washington, DC WRIISC site via an encrypted AZURE
email between VA email addresses. Participants will be referred to Palo
Alto and give contact information for our site.
f)
If data or specimens will be coded, describe the method in which they will be coded so that study
participants' identities cannot be readily ascertained from the code.
A study code is assigned to a subject after they sign a consent form.
This code is independent of any identifying information.
g)
If data or specimens will be coded, indicate who will maintain the key to the code and describe how it
will be protected against unauthorized access.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 26 of 39
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Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

The code will be maintained by the PI, and will be available to
appropriate members of the research team but kept in a locked file
cabinet or on a physically secure, password protected computer at VA
Palo Alto.
h)
If sharing data with others, describe how data will be transferred or transmitted (e.g., file transfer
software, file sharing, email). If transmitted via electronic networks, confirm a Stanford University IT
approved platform will be used (see https://uit.stanford.edu/guide/riskclassifications
https://uit.stanford.edu/guide/riskclassifications) or that data will be encrypted while in transit.
Additionally, confirm appropriate agreements are in place to allow for the sharing (see
https://ico.stanford.edu/stanford-researchers/who-will-handle-my-agreement
https://ico.stanford.edu/stanford-researchers/who-will-handle-my-agreement). If using or sharing PHI,
refer to the following policies: https://uit.stanford.edu/security/hipaa
https://uit.stanford.edu/security/hipaa.
Data transfer will be between VA hospitals, using secure VA protocols
behind the VA firewalls.
The DC WRIISC site will transfer PHI (first and last name, mailing address, phone
number) to Palo Alto via a VA AZURE
encrypted email between VA email addresses. This data will then be
stored on physically secure and password protected computer servers
behind a firewall at the VAPAHCS with all other PHI for this study. The
Palo Alto site will not transfer any PHI to the other sites.
i)
How will you educate research staff to ensure they take appropriate measures to protect the privacy of
participants and the confidentiality of data or specimens collected (e.g. conscious of oral and written
communications, conducting insurance billing, and maintaining paper and electronic data)?
All research staff will complete and remain current with all required
VA
and Stanford training prior to working with human subjects. The
Protocol
Director will also reinforce the importance of maintaining
confidentiality.
12. Potential Conflict of Interest
Investigators are required to disclose any outside interests that reasonably appear to be related/li to this protocol.
Outside Interest Tasks
Investigators
Role
Potential
COI?
Date
Outside
Interest
Answered
Date OPACS
Disclosure
Submitted
COI Review
Determination
Jerome A
Yesavage
PD
N
08/05/2024
N/A
Andrea Nicole
COP
N
08/05/2024
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 27 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Goldstein
D
N/A
Laura
Lazzeroni
OP
N
08/05/2024
N/A
13. Consent Background
13. 1
Consent
22-AUG-2022 Gulf War Insomnia Consent
Check if VA related
Y
a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
v) What steps are you taking to minimize the possibility of coercion and undue influence?
vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
(i) The persons obtaining consent will be one of the investigators, the study coordinator, or a research
assistant, who have been trained to give informed consents. (ii) The consenting interview is always done
after the potential research subject has been presented with a description of the study and indicated interest
in participating, and before any information is collected, or any questionnaires answered. The consenting
interview typically takes place in one of the private interview rooms in the Aging Clinical Research Center.
For telehealth sessions, the consent process will be completed through Zoom. Study staff will review the
consent with the participant. If the participant agrees, they will sign the consent form through a fillable PDF
form in Adobe. Study Staff will share the screen with participants and participants will take control of the
screen to sign the form. Participants will be sent a copy of the signed consent form. If the participant is
unable to attend the consenting interview on a computer, multiple copies of the consent form will be mailed
to them in advance. The participant will have the physical consent form in front of them while the study
staff reviews the consent form. The participant will be provided a pre-paid return envelope to mail one
signed copy of the consent form back to the VA. (iii) Enough time will be allowed for the consent
discussion for the potential participant to make an informed decision, and to ask any and all questions they
may have and discuss the study with the researchers. We estimate this will take between 30 minutes and one
hour. (iv) The potential participant may take the consent home to discuss with family or others, and return
later to sign it if they so desire. (v) Every attempt will be made to ensure the participant does not feel
coerced. Participants are allowed as much time as needed to discuss the project with the research staff. If
desired by the participant, the signing of the consent is delayed for as long as needed to allow participants to
discuss the project with family, personal health care providers, or others. We believe that the payment
offered for participation is not great enough to entice a person to participate if they do not want to do so. (vi)
Not applicable.
b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
The potential subject will be asked questions about the study to make sure they understand. All participants
will have a good understanding of English, since the standardized forms, questionnaires, and tests used are
not currently available in other languages. Hearing impairment severe enough to impair comprehension is
an exclusion criteria for a similar reason.
c)
What steps are you taking to determine that potential participants have the capacity to participate in
the decision-making process? If your study may enroll adults who are unable to consent, describe (i)
how you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains
the capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
We expect all persons who meet inclusion criteria will have capacity to give informed consent.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
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Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Additional VA questions:
i)
List the people to whom you have formally delegated responsibility to obtain informed consent, and
state whether they have the appropriate training to perform this activity.
The persons obtaining consent will be one of the investigators, the study coordinator, or a research assistant,
all of whom have been trained to give informed consents. All staff have completed the required training in
Human Subjects, Good Clinical Practice, and HIPAA.
ii)
Will legally effective informed consent be obtained from the participant or the participant's legally
authorized representative (LAR) or both? If LAR, is it clear who can serve as LAR?
Consent will be obtained from the participant.
iii)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence
and provide the prospective participant or their representative sufficient opportunity to consider
whether to participate?
Participants are allowed as much time as needed to discuss the project with the research staff. If desired by
the participant, the signing of the consent is delayed for as long as needed to allow participants to discuss
the project with family, personal health care providers, or others.
iv)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
Participants are allowed as much time as needed to discuss the project with the research staff. If desired by
the participant, the signing of the consent is delayed for as long as needed to allow participants to discuss
the project with family, personal health care providers, or others.
v)
Will the information being communicated to the participant or the representative during the consent
process exclude any exculpatory language through which the participant or the representative is made
to waive or appear to waive the participant's legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agent from liability for negligence (e.g. I give up any
property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?
All information presented to the participant, including anything they must sign, has been approved by the
IRB.
vi)
Please confirm the following:
a. A witness to the participant's signature or the participant's legally authorized representative's
signature will sign and date the consent document.
b. If the sponsor or the IRB requires a witness to the consenting process in addition to the witness to
the participant's signature and if the same person is needed to serve both capacities, a note to that
effect is placed under the witness's signature line.
c. A copy of the signed and dated consent document will be given to the person signing the consent
document.
d. The consent form is on the VA Form 10-1086.
13. 2
Waiver of Documentation
GulfWar Insomnia Remote Phone Screen04-MAR-2021
Check if VA related
Y
a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
v) What steps are you taking to minimize the possibility of coercion and undue influence?
vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
(i) The persons obtaining consent will be one of the investigators, the study coordinator, or a research
assistant, who have been trained to give informed consents. (ii) The telephone interview is always done after
the potential research subject has been presented with a description of the study and indicated interest in
participating, and has given verbal consent. (iii) Enough time will be allowed for the consent discussion for
the potential participant to make an informed decision, and to ask any and all questions they may have and
discuss the study with the researcher. (iv) The potential participant may take the time to discuss with family
or others, and call back later to complete the interview if they so desire. (v) Every attempt will be made to
ensure the participant does not feel coerced. Participants are allowed as much time as needed to discuss the
project with the research staff. (vi) Not applicable.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 29 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
The potential subject will be asked questions about the study to make sure they understand. All participants
will have a good understanding of English. Hearing impairment severe enough to impair comprehension is
an exclusion.
c)
What steps are you taking to determine that potential participants have the capacity to participate in
the decision-making process? If your study may enroll adults who are unable to consent, describe (i)
how you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains
the capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
If there is any question about a potential participant's capacity to give consent, he or she will be evaluated
by a staff psychiatrist or psychologist at an in-person or over a Zoom interview instead of a telephone
screen.
Additional VA questions:
i)
List the people to whom you have formally delegated responsibility to obtain informed consent, and
state whether they have the appropriate training to perform this activity.
The persons obtaining consent and administering the telephone screen will be one of the investigators, the
study coordinator, or a research assistant, all of whom will have been trained to give informed consents. All
staff have completed the required training in Human Subjects, Good Clinical Practice, and HIPAA.
ii)
Will legally effective informed consent be obtained from the participant or the participant's legally
authorized representative (LAR) or both? If LAR, is it clear who can serve as LAR?
Consent for the phone screen will be obtained from the person answering the telephone interview questions.
iii)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence
and provide the prospective participant or their representative sufficient opportunity to consider
whether to participate?
Participants are allowed as much time as needed to discuss the project with the research staff. If desired by
the participant, the telephone screen is delayed for as long as needed to allow participants to discuss the
project with family, personal health care providers, or others. The participant is urged to call back after
discussing the study with family or friends.
iv)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
The researcher will explain the interview to the potential participant, and answer any questions they may
have. The potential participant is free to end the interview and disconnect at any time.
v)
Will the information being communicated to the participant or the representative during the consent
process exclude any exculpatory language through which the participant or the representative is made
to waive or appear to waive the participant's legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agent from liability for negligence (e.g. I give up any
property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?
The attached phone script will be followed by the interviewer.
vi)
Please confirm the following:
a. A witness to the participant's signature or the participant's legally authorized representative's
signature will sign and date the consent document.
b. If the sponsor or the IRB requires a witness to the consenting process in addition to the witness to
the participant's signature and if the same person is needed to serve both capacities, a note to that
effect is placed under the witness's signature line.
c. A copy of the signed and dated consent document will be given to the person signing the consent
document.
d. The consent form is on the VA Form 10-1086.
Select ALL applicable regulatory criteria for a Waiver of Documentation and provide a protocol-specific
justification:
1)
45 CFR 46.117(c)(1)(i)., that the only record linking the participants and the research would be
the consent document, and the principal risk would be potential harm resulting from a breach
of confidentiality; each participant (or legally authorized representative) will be asked whether
he/she wants documentation linking the participant with the research, and the participant's
wishes govern.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 30 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

2)
Y
45 CFR 46.117(c)(1)(ii)., that the research presents no more than minimal risk of harm to
participants and involves no procedures for which written consent is normally required outside
of the research context.
3)
45 CFR 46.117(c)(1)(iii)., if participants or legally authorized representatives (LAR) are
members of a distinct cultural group in which signing forms is not the norm, the research
presents no more than minimal risk and there is an appropriate alternative mechanism for
documenting that informed consent was obtained.
4)
21 CFR 56.109(c)(1)., presents no more than minimal risk of harm to participants and involves
no procedures for which written consent is normally required outside of the research context.
Rationale for above selection:
See attached phone script.
13. 3
Waiver of Documentation
StudyPages_Prescreen_Consent_JULY-2021
Check if VA related
Y
a)
Describe the informed consent process. Include the following.
i) Who is obtaining consent? (The person obtaining consent must be knowledgeable about the study.)
ii) When and where will consent be obtained?
iii) How much time will be devoted to consent discussion?
iv) Will these periods provide sufficient opportunity for the participant to consider whether or not to
participate and sign the written consent?
v) What steps are you taking to minimize the possibility of coercion and undue influence?
vi) If consent relates to children and if you have a reason for only one parent signing, provide that
rationale for IRB consideration.
(i) Consent to complete the pre-screening survey will be obtained electronically on the survey through the
study landing page. The study landing page will contain a description of the study purpose, procedures, and
requirements. Interested subjects will be instructed that by clicking “Next” on the pre-screening survey, they
are consenting to participate in the pre-screening questionnaire and that all of their information is
confidential. (ii) Contact with interested subjects is minimal until completion of the pre-screening
questionnaire. Interested subjects will be led to the study landing page after selecting one of the social
media study ads. Then after reviewing the study information, they may choose to select the button on the
page which will bring up the pre-screening survey. Consent to complete the pre-screening survey will be
obtained after the participant reads the instructions and consent/HIPAA information regarding the
pre-screening survey questions provided for them, and after they select “Next” to advance to the
pre-screening questions. (iii) The interested subjects will be able to review the information in the study
landing page and pre-screening survey consent page for as long as needed and be instructed to contact the
study coordinator with any questions they may have before filling out the pre-screening survey. (iv) The
potential participant may take the time to discuss with family or others, and return to the survey whenever
they feel ready to proceed. (v) Every attempt will be made to ensure the participant does not feel coerced.
Participants are instructed to reach out if they have any questions before agreeing to answer any questions
and are allowed as much time as needed to discuss the project with the research staff. (vi) Not applicable.
b)
What is the Procedure to assess understanding of the information contained in the consent? How will
the information be provided to participants if they do not understand English or if they have a hearing
impairment? See HRPP Chapter12.2 for guidance.
The potential subject will be provided with the study coordinators contact information multiple times on the
study landing page and the pre-screening survey. This will include instructions to reach out if they have any
questions. This is done to ensure they understand that by filling out the survey they assert their interest in
participating in the study and to be contacted by the study team to determine their eligibility to enroll in the
study. All participants will have a good understanding of English. Hearing impairment conditions are not
applicable at this stage.
c)
What steps are you taking to determine that potential participants have the capacity to participate in
the decision-making process? If your study may enroll adults who are unable to consent, describe (i)
how you will assess the capacity to consent, (ii) what provisions will be taken if the participant regains
the capacity to consent,(iii) who will be used as a legally authorized representative, and (iv) what
provisions will be made for the assent of the participant.
Interested subjects will require the use of an electronic device and social media in order to reach our study
landing page and follow the prompts to complete the survey. Their ability to give consent will be further
assessed over the phone interview and if there is any question about a potential participant's capacity to give
consent, he or she will be evaluated by a staff psychiatrist or psychologist at over a Zoom interview instead
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 31 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

of a telephone screen.
Additional VA questions:
i)
List the people to whom you have formally delegated responsibility to obtain informed consent, and
state whether they have the appropriate training to perform this activity.
The language and procedures for obtaining electronic consent will be the same across all interested subjects
that reach our study landing page. Additionally, the persons overseeing the use of the study landing page
will be one of the investigators, the study coordinator, or a research assistant, all of whom will have been
trained to give informed consents. All staff have completed the required training in Human Subjects, Good
Clinical Practice, and HIPAA.
ii)
Will legally effective informed consent be obtained from the participant or the participant's legally
authorized representative (LAR) or both? If LAR, is it clear who can serve as LAR?
Consent for the pre-screening survey and to be contacted will be obtained from the possible participant
(person completing the survey questions).
iii)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence
and provide the prospective participant or their representative sufficient opportunity to consider
whether to participate?
Participants are allowed as much time as needed to discuss the project with the research staff if needed. If
desired by the participant, the electronic pre-screen is delayed for as long as needed to allow participants to
discuss the project with family, personal health care providers, or others.
iv)
Will the circumstances of the consent process minimize the possibility of coercion or undue influence?
The study landing page and pre-screening survey will have multiple prompts/instructions that explain the
pre-screening procedures to the potential participant, and instructs them to call the study coordinators to
answer any questions they may have. The potential participant is free to end the survey and disconnect at
any time.
v)
Will the information being communicated to the participant or the representative during the consent
process exclude any exculpatory language through which the participant or the representative is made
to waive or appear to waive the participant's legal rights, or release or appear to release the
investigator, the sponsor, the institution, or its agent from liability for negligence (e.g. I give up any
property rights I may have in bodily fluids or tissue samples obtained in the course of the research)?
The attached pre-screening script will be presented on the study landing page.
vi)
Please confirm the following:
a. A witness to the participant's signature or the participant's legally authorized representative's
signature will sign and date the consent document.
b. If the sponsor or the IRB requires a witness to the consenting process in addition to the witness to
the participant's signature and if the same person is needed to serve both capacities, a note to that
effect is placed under the witness's signature line.
c. A copy of the signed and dated consent document will be given to the person signing the consent
document.
d. The consent form is on the VA Form 10-1086.
Select ALL applicable regulatory criteria for a Waiver of Documentation and provide a protocol-specific
justification:
1)
45 CFR 46.117(c)(1)(i)., that the only record linking the participants and the research would be
the consent document, and the principal risk would be potential harm resulting from a breach
of confidentiality; each participant (or legally authorized representative) will be asked whether
he/she wants documentation linking the participant with the research, and the participant's
wishes govern.
2)
Y
45 CFR 46.117(c)(1)(ii)., that the research presents no more than minimal risk of harm to
participants and involves no procedures for which written consent is normally required outside
of the research context.
3)
45 CFR 46.117(c)(1)(iii)., if participants or legally authorized representatives (LAR) are
members of a distinct cultural group in which signing forms is not the norm, the research
presents no more than minimal risk and there is an appropriate alternative mechanism for
documenting that informed consent was obtained.
4)
21 CFR 56.109(c)(1)., presents no more than minimal risk of harm to participants and involves
no procedures for which written consent is normally required outside of the research context.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 32 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Rationale for above selection:
We are collecting a brief online prescreen questionnaire with minimal risk to participants. They will
be provided with full study description and consent information with HIPAA related to use of their
prescreen questionnaire responses.
14. Assent Background (less than 18 years of age)
15. HIPAA Background
15. 1
Authorization
gulfwarinsomnia va hipaa auth
15. 2
Waiver of Authorization for
Recruitment
waiver of authorization for recruitment
a)
Describe the protected health information (PHI) needed to conduct screening or recruitment. PHI is
health information linked to HIPAA identifiers. List BOTH health information AND HIPAA
identifiers. If you are using STARR, use the Data Privacy Attestation to ensure that your request will
match your IRB-approved protocol.
Chart reviews will be conducted to assist in identifying prospective participants. Additionally, contact
information (name, mailing address, phone number) from the Gulf War Registry, WRIISC, DMDC
databases, and DC WRIISC site of this study, and the StudyPages outreach campaign will be utilized to
identify and recruit participants. In addition, the Washington, DC WRIISC site will share contact
information (name, mailing address, phone number) with the Palo Alto site for recruitment. We will send
letters and call possible participants from these three databases as well as from the Washington, DC
WRIISC and StudyPages list of interested participants. We are requesting a waiver of authorization for the
chart review and also for the StudyPages Prescreening: Consent to complete the pre-screening survey will
be obtained electronically on the survey through the study landing page. Interested subject will reach the
study landing page by clicking the link on the StudyPages online posting/advertisements. The study landing
page will contain a description of the study purpose, procedures, requirements, and study staff contact
information. Interested subjects will need to select the “See if you may qualify” button on the study landing
page so that the initial prescreening survey prompt box appears which will instruct subjects that they should
call the clinical coordinators using the study phone number if they have any questions and review the
consent and HIPAA information for the prescreening survey questions, and then that by clicking “Next” on
the pre-screening survey, they are i) consenting to participate in the pre-screening questionnaire, ii) agreeing
with the information they read regarding the prescreen survey and how their information will be
used/protected, iii) agreeing to proceed to the prescreening questions, and iv) that all of their information is
confidential. Interested subjects will only be able to proceed if they click “Next” after reviewing the consent
form information before the next page appears that allows them to respond to the prescreening questions
(included in the StudyPages document in section 16). Upon completion an successful submission of their
responses, subjects will be notified that the study team will reach out to them regarding their eligibility. The
study team will then review the prescreening responses and call interested subjects We are collecting the
following identifiable data during recruitment and the pre-screen: full name, mailing address, social security
number, telephone number, age, Health information about the participant pertaining to inclusion/exclusion
criteria, including information about general health (sleep disturbance or insomnia, sleep disorders, general
medical conditions, medications, therapy, height, weight, etc.) related to medical treatments and care they
receive.
b)
Please Answer:
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 33 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Y
Do you certify that the use or disclosure of protected health information involves no more than a
minimal risk to the privacy of individuals?
Y
Do you certify that the research could not practically be conducted with out the waiver?
Y
Do you certify that you have adequate written assurances that the protected health information will
not be reused or disclosed to any other person or entity, except as required by law, for authorized
oversight of the research project, or for other research for which the use or disclosure of protected
health information would be permitted?
Y
Do you certify that the research could not practically be conducted with out access to and use of the
protected health information?
c)
Please describe an adequate plan to protect any identifiers from improper use and disclosure.
All information from VA affiliated sites will be kept in locked cabinets in locked offices, or on computer
servers behind the VAPA firewall. Information from the StudyPages outreach campaign will be encrypted
with 256-bit AES encryption in the StudyPages Application Database. A copy of this data will be stored on
computer servers behind the VAPA firewall.
d)
Please describe an adequate plan to destroy the identifiers at the earliest opportunity consistent with
conduct of the research, unless there is a health or research justification for retaining the identifiers
or such retention is otherwise required by law.
Information will be kept or destroyed following current VA requirements.
16. Attachments
Attachment Name
Attached Date
Attached By
Submitted Date
GulfWarInsomnia Egrant
07/22/2016
emilyg
Berlin Questionnaire
09/28/2016
emilyg
BRIEF PAIN INVENTORY
09/28/2016
emilyg
Columbia_Suicide_Severity_
Rating_Scale
09/28/2016
emilyg
Dysfunctional Beliefs about
Sleep
09/28/2016
emilyg
Epworth Sleepiness Scale
09/28/2016
emilyg
HAMD
09/28/2016
emilyg
Life_stressor_Checklist_Revi
sed
09/28/2016
emilyg
Penn_State_Worry_Questionn
aire
09/28/2016
emilyg
Sleep Diary
09/28/2016
emilyg
Protocol 38548
VARQs_APP1m-1
09/28/2016
emilyg
Anxiety_and_Preoccupation_
about_Sleep_Questionnaire
03/29/2017
emilyg
AUA8_Nocturia
03/29/2017
emilyg
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 34 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

BAI
03/29/2017
emilyg
BDI
03/29/2017
emilyg
Color_Word_Interference_D-
KEFS
03/29/2017
emilyg
DASS-21
03/29/2017
emilyg
Functional_Outcomes_of_Sle
ep_Questionnaire
03/29/2017
emilyg
Glascow_Content_of_Though
ts
03/29/2017
emilyg
Glasgow_Sleep_Effort_Scale
03/29/2017
emilyg
MOCA
03/29/2017
emilyg
Multidimensional_Fatigue_In
ventory
03/29/2017
emilyg
Perceived_Stress_Scale
03/29/2017
emilyg
RBANS
03/29/2017
emilyg
SF-36_RAND
03/29/2017
emilyg
Trail_Making_Test
03/29/2017
emilyg
Treatment Adherance
Questionnaire_BT_5.5.14
03/29/2017
emilyg
Treatment Adherance
Questionnaire_CT_5.5.14
03/29/2017
emilyg
Treatment Satisfaction Survey 03/29/2017
emilyg
WAI participant
03/29/2017
emilyg
WAI Therapist
03/29/2017
emilyg
Gulf War Insomnia Certificate
of Confidentiality
03/31/2017
emilyg
CAPS past month
05/29/2017
agoldpie
CAPS worst month
05/29/2017
agoldpie
Credibility/Expectancy
Survey
05/29/2017
agoldpie
DUKE
05/29/2017
agoldpie
Insomnia Severity Index
05/29/2017
agoldpie
MEQ
05/29/2017
agoldpie
SAMI
05/29/2017
agoldpie
TCQI
05/29/2017
agoldpie
Goldstein CITI
06/02/2017
agoldpie
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 35 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

Approved AmendedCoC
08/29/2017
emilyg
Brochure_091317
09/13/2017
agoldpie
Flyer_091317
09/13/2017
agoldpie
Flyer_withNibs_091317
09/13/2017
agoldpie
Buisness_Cards_091317
09/13/2017
agoldpie
Newspaper_ad_091317
09/13/2017
agoldpie
Recruitment Letter Prior
Study 041818
04/18/2018
agoldpie
Recruitment Letter New
Contact 041818
04/18/2018
agoldpie
DC Site IRB Approval 2018
09/05/2018
agoldpie
NJ Site IRB Approval 2018
09/05/2018
agoldpie
Additional Demographics
questions
02/01/2019
agoldpie
NJ site approval 2019
08/28/2019
kohora
DC site approval 2019
08/30/2019
kohora
2019FlyerQR
09/05/2019
kohora
2019FlyernoQR
09/05/2019
kohora
DSMB2020
08/25/2020
kohora
GW_national_recruitment_po
stcard
08/25/2020
kohora
GW_national_recruitment_po
ster_v5_no_email
08/25/2020
kohora
RecruitmentLetterNewContac
t082420
08/27/2020
kohora
SocialMedia_ad_082420
08/27/2020
kohora
GW_national_recruitment_po
ster_v7_no_email
10/06/2020
amorehse
NJ site IRB Approval
07-JAN-2020
10/27/2020
amorehse
DC site IRB Approval
15-APR-2020
10/27/2020
amorehse
Fillable 102720 Gulf War
Insomnia Consent
10/27/2020
amorehse
TheCoRonavIruSHealthImpac
tSurvStable
11/05/2020
amorehse
TheCoRonavIruSHealthImpac 11/05/2020
amorehse
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 36 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

tSurvChange
DSMB_2021
02/09/2021
amorehse
MoCA-BLIND
02/09/2021
amorehse
Fillable 09-FEB-2021 Gulf
War Insomnia Consent
02/12/2021
amorehse
GW Letter Remote
24-FEB-2021
03/03/2021
amorehse
GW_national_recruitment_po
ster_for_DC
03/15/2021
amorehse
WRIISC_GW Letter Remote
11-MAR-2021
03/15/2021
amorehse
Fillable 04-MAR2021 Gulf
War Insomnia Consent clean
03/15/2021
amorehse
Waiver_of_Auth_of_recruit_
GW_05-MAR-2021
03/15/2021
amorehse
GW_national_recruitment_po
ster02APR21
04/02/2021
amorehse
Fillable 02-APR-2021 Gulf
War Insomnia Consent
04/02/2021
amorehse
DC_DUA_Internal_7April20
21 signed
06/10/2021
amorehse
GW_ScreeningPacketCoverL
etter_14-JUN-2021
06/15/2021
amorehse
05052021_Gulf War study_
CampaignCreative
07/28/2021
mlopez3
05052021_Gulf War study_
Prescreen_Survey
07/28/2021
mlopez3
2021-01-07_NJ_Approval
08/20/2021
amorehse
02-JUN-2021_DC_Approval
08/23/2021
amorehse
Waiver_of_Auth_of_recruit_
GW_12-AUG-2021
08/26/2021
sutm
GW_DSMB_29-JUN-2022
07/22/2022
amorehse
31-JAN-2022_DC_Approval
08/19/2022
acirelli
NJ_IRB_annual protocol
check
in_2022_acknowledgement
08/22/2022
acirelli
DSMB closing report 2023
07/10/2023
agoldpie
DC_IRB_Project Closure
Form CBTI study 10Jan2023
07/20/2023
acirelli
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 37 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

DC_Reinhard Transition
Letter (signed)
07/20/2023
acirelli
NJ_annual protocol check
in_2022_acknowledgement
07/20/2023
acirelli
GW_Consent_Audit_report_e
mail_25-JUL-2023
07/28/2023
acirelli
GW_Consent_Audit_July_20
23_1
07/28/2023
acirelli
Reinhard 01858 IRB
Closure-Signed
08/22/2024
eileenf1
VANJHCS IRB Closure
Letter 2024 0410 (1)
08/22/2024
eileenf1
Obligations
The Protocol Director agrees to:
•
Adhere to principles of sound scientific research designed to yield valid results
•
Conduct the study according to the protocol approved by the IRB
•
Be appropriately qualified to conduct the research and be trained in Human Research protection, ethical
principles, regulations, policies and procedures
•
Ensure all Stanford research personnel are adequately trained and supervised
•
Ensure that the rights and welfare of participants are protected including privacy and confidentiality of data
•
Ensure that, when de-identified materials are obtained for research purposes, no attempt will be made to
re-identify them.
•
Disclose to the appropriate entities any potential conflict of interest
•
Report promptly any new information, modification, or unanticipated problems that raise risks to
participants or others
•
Apply relevant professional standards.
Any change in the research protocol must be submitted to the IRB for review prior to the implementation of
such change. Any complications in participants or evidence of increase in the original estimate of risk should
be reported at once to the IRB before continuing with the project. Inasmuch as the Institutional Review
Board (IRB) includes faculty, staff, legal counsel, public members, and students, protocols should be written
in language that can be understood by all Panel members. The investigators must inform the participants of
any significant new knowledge obtained during the course of the research.
IRB approval of any project is for a maximum period of one year. For continuing projects and activities, it is
the responsibility of the investigator(s) to resubmit the project to the IRB for review and re-approval prior to
the end of the approval period. A Notice to Renew Protocol is sent to the Protocol Director 7 weeks prior to
the expiration date of the protocol.
https://stanfordmedicine.box.com/shared/static/qbsi8u8h47qsotxhdpuzz50xlrqa0sgo.pdf Report promptly any
new information, complaints, possibly serious and/or continuing noncompliance, or unanticipated problems
involving risks to participants or others.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 38 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025

All data including signed consent form documents must be retained for a minimum of three years past the
completion of the research. Additional requirements may be imposed by your funding agency, your
department, or other entities. (Policy on Retention of and Access to Research Data, Research Policy
Handbook,
http://doresearch.stanford.edu/policies/research-policy-handbook/conduct-research/retention-and-access-research-data)
APPROVAL LETTER/NOTICE NOTE: List all items (verbatim) that you want to be included in your
approval letter (e.g., Amendment date, Investigator's Brochure version, consent form(s) version(s),
advertisement name, etc.) in the box below.
Y
By checking this box, I verify that I, as the Protocol Director (PD) responsible for this research protocol,
have read and agree to abide by the above obligations, or that I have been delegated authority by the PD to
certify that the PD has read and agrees to abide by the above obligations.
Protocol # 38548 ( Continuing Review )
PROTOCOL
PD: Jerome A Yesavage
APPLICATION FORM
Page 39 of 39
Review Type: Regular
Human Subjects Research
Medical
Stanford University
Title :
Predictors of Response to Insomnia Treatments for Gulf War Veterans
Approval Period:
08/31/2024 - 08/31/2025