SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)
Phase: NA
Conditions: Insomnia
Sponsor: VA Office of Research and Development

 
IRBNet ID:   
 
1638783 
Title:  
SEdative-Hypnotic Deprescribing Assisted by a Technology-
Driven Insomnia InterVEntion (SEDATIVE) 
eRA Commons ID:  
RX003732-01A1 
Funding Agency:   
VA Rehabilitation Research & Development Service 
Principal Investigator:  
Adam Bramoweth, PhD 
Version Date: 
 
v.7 01/24/2023 
 
 
 
 

 
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Summary 
Chronic insomnia is one of the most common health problems among Veterans and significantly 
impacts their health, function, and quality of life. Sedative-hypnotic medications are the most 
common treatment despite mixed effectiveness and are associated with numerous risks that can 
further impact Veteran function. The Clinician Operated Assistive Sleep Technology (COAST) is 
an efficient, scalable, and adaptable digital platform that can help providers to reach more 
Veterans and provide evidence-based care for insomnia that translates to improved health and 
function. COAST delivery of cognitive behavioral therapy for insomnia (CBT-I) will be combined 
with Clinical Pharmacist-led sedative-hypnotic deprescribing to integrate two previously siloed 
interventions to deliver efficient evidence-based care.  
This is a non-randomized, single group clinical trial: 
Aim 1: 
To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to 
participate in a 12-week combined deprescribing and CBT-I intervention, delivered 
through the COAST digital platform. 
Aim 2: 
To assess Veteran acceptability and usability of the COAST platform. 
Aim 3: 
To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-
intervention. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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List of Abbreviations 
BBTI 
brief behavioral treatment for insomnia 
BSC 
Behavioral Sleep Clinic 
CBT-I 
cognitive behavioral therapy for insomnia 
CDA 
Career Development Award 
CDW 
Corporate Data Warehouse 
CIWA 
Clinical Institute Withdrawal Assessment Scale - Benzodiazepines 
COAST 
Clinician Operated Assistive Sleep Technology 
Co-I 
co-investigator 
COVID-19 
coronavirus disease 2019 
CPP 
Clinical Pharmacy Practitioner 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
GDR 
gradual dose reduction 
HIPAA 
Health Insurance Portability and Accountability Act 
HSR&D 
Health Services Research and Development 
ID 
identification 
IIR 
investigator initiated research 
ISI 
Insomnia Severity Index 
ISSO 
information system security officer 
M 
mean 
N/A 
not applicable 
NWAK 
number of awakenings 
PCMHI 
Primary Care Mental Health Integration 
PI 
principal investigator 
PROMIS 
Patient-Reported Outcomes Measurement Information System  
PSSUQ 
Post-Study System Usability Questionnaire 
RR&D 
Rehabilitation Research and Development 
SD 
standard deviation 
SE 
sleep efficiency 
SOL 
sleep onset latency 
SPiRE 
Small Projects in Rehabilitation Research 
SQ 
sleep quality 
TIB 
time in bed 
TST 
total sleep time 
US 
United States 
VA 
Department of Veterans Affairs 
VAPHS 
VA Pittsburgh Healthcare System 
WASO 
wake after sleep onset 
 
 

 
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Contents 
1.0 
Study Personnel ............................................................................................................................. 4 
2.0 
Introduction .................................................................................................................................... 5 
3.0 
Objectives ...................................................................................................................................... 8 
4.0 
Resources ...................................................................................................................................... 8 
5.0 
Study Procedures ........................................................................................................................ 10 
5.1 Study Design ................................................................................................................................. 10 
5.2 Study Population, Recruitment Methods, and Informed Consent Process ................................... 17 
5.3 Data Analysis ................................................................................................................................ 20 
5.4 Withdrawal of Subjects .................................................................................................................. 21 
6.0 
Data Safety Monitoring ................................................................................................................ 21 
7.0 
Privacy and Confidentiality ........................................................................................................... 22 
8.0 
Collaborative/Multisite Research ................................................................................................. 22 
9.0 
References ................................................................................................................................... 24 
 
 
 
 

 
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1.0 
Study Personnel 
• VA Pittsburgh Healthcare System (VAPHS) 
Adam Bramoweth, PhD – Principal Investigator/Clinician 
Dr. Bramoweth is a Research Health Scientist/Core Investigator with the VAPHS 
CHERP/MIRECC and a Staff Psychologist in the Behavioral Health Service Line at VAPHS. 
He leads a program of research at VAPHS focused on improving access to insomnia-
related care. As PI, Dr. Bramoweth will be responsible for directing and overseeing all study 
activities and will also serve as the insomnia clinician, responsible for the delivery of 
behavioral insomnia care facilitated by the COAST digital health platform. 
  
Amanda McQuillan, PharmD – Co-Investigator/Clinical Pharmacist 
Brittany Spitznogle, PharmD – Co-Investigator/Clinical Pharmacist 
Drs. McQuillan and Spitznogle are Clinical Pharmacy Practitioners (CPPs) and Mental 
Health Clinical Pharmacy Specialists at VAPHS. Drs. McQuillan and Spitznogle will serve 
as the study’s CPPs and will be responsible for the development, delivery, and monitoring 
of the participants’ sedative-hypnotic taper. They will help coordinate any necessary 
prescription renewals and dosage changes with participants’ prescribing providers. 
 
Carolyn Thorpe, PhD, MPH – Co-Investigator 
Dr. Thorpe is Associate Professor of Pharmacy at the University of North Carolina at 
Chapel Hill and a Core Investigator at the VAPHS CHERP. Dr. Thorpe will provide her 
expert knowledge regarding deprescribing, in collaboration with Dr. McQuillan, to design 
appropriate and personalized medication taper schedules for participants. Dr. Thorpe will 
make her contributions remotely from North Carolina. 
 
Megan Hamm, PhD – Co-Investigator/Qualitative Analyst 
Dr. Hamm is a WOC member of the MIRECC and will lead the qualitative analyses. Dr. 
Hamm’s position will be supported by an IPA through the University of Pittsburgh. Dr. 
Hamm will help to develop the interview guide, will train the study coordinator to conduct 
the interviews, and will lead the rapid analysis template, summary, coding, and analysis.   
 
• VA Madison Healthcare System/William S. Middleton Memorial Veterans’ Hospital 
James Lickel, PhD – Co-Investigator/Clinician 
Dr. Lickel is a Staff Psychologist at the William S. Middleton Memorial Veterans Hospital 
(Madison VA). He serves as the Coordinator of the Behavioral Sleep Clinic (BSC). Within 
the BSC he coordinates referrals, develops and maintains clinic offerings, supervises 
psychology and other discipline trainees, and provides direct psychological services to 
Veterans, including CBT-I and assisting with sedative-hypnotic tapers. As a Co-I/Clinician, 
he will provide clinical expertise on insomnia, CBT-I, and deprescribing to Drs. Bramoweth 
and McQuillan, join study team meetings, and contribute to study analyses and 
dissemination efforts. He will also assist Dr. Bramoweth as a study clinician, delivering 
CBT-I through the COAST platform. 
 

 
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• Consultant 
Anne Germain, PhD – NOCTEM COAST Consultant 
Dr. Germain is the Founder and CEO of NOCTEM Health, Inc, a digital sleep therapeutics 
start-up company, and Professor Emeritus of Psychiatry at the University of Pittsburgh 
School of Medicine. Dr. Germain is an internationally recognized sleep researcher with a 
program of research emphasizing the assessment and treatment of sleep disorders within 
military and Veteran populations. As a study consultant and insomnia Subject Matter 
Expert, Dr. Germain and her team will lead training for the NOCTEM COAST digital 
platform and provide ongoing and as needed consultation with study staff regarding any 
technical issues related to COAST.  
 
• Non-Financial Conflicts of Interest 
N/A 
2.0 
Introduction 
• Scientific Background/Rationale 
Chronic insomnia has significant impact on Veterans’ health, function, and quality of 
life as one of the most common health problems among Veterans.1–3 Insomnia 
impacts over 50% of Veterans2,4 and significantly contributes to functional impairment, 
fatigue, and reduced alertness, memory, attention, and concentration.5–7 Insomnia reduces 
quality of life and social functioning, and there is a relationship between insomnia and 
increased days of work missed and impaired work performance.8,9 Insomnia also negatively 
affects comorbid health problems and increases risk of depression, anxiety, substance use, 
chronic pain, cardiometabolic disorders, and even suicide behaviors, all of which further 
impair function and quality of life.10–12 Additionally, the COVID-19 pandemic continues to 
cause significant stress and worry about health, including increased rates of insomnia as 
high as 38% and increased prescriptions for sedative-hypnotic medications.13–15  
Sedative-hypnotic use is highly prevalent and is not aligned with best practices for 
the treatment of insomnia. Furthermore, sedative-hypnotics are associated with 
increased risks, functional impairment, and negative quality of life and health 
outcomes.16–18 Sedative-hypnotics are commonly prescribed to treat insomnia, ranging 
from 5-14% in large cohort studies, and even higher rates from survey studies (upwards of 
25%).19,20 Although considered effective for the short-term treatment of insomnia, a few 
weeks to months, these medications are often taken well beyond one year.21,22 Use of 
sedative-hypnotics, especially benzodiazepines, can result in tolerance, dependence, 
and/or abuse.16 Furthermore, they only treat insomnia symptoms rather than underlying 
causal factors and discontinuation often results in rebound insomnia.16 Sedative-hypnotics 
are also associated with risk for daytime fatigue, impaired cognitive and psychomotor 
functioning, falls and fractures,17 as well as rare, yet serious, events such as sleep-
driving.18 Epidemiological research also links increased doses of sleep medication, taken 
for at least one year, to an elevated incidence of cancer and an increased risk of death 

 
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(controlling for prior cancer diagnosis).23 Importantly, many Veterans don’t want to take 
sedative-hypnotics if an alternative is available.24 Although the most common treatment by 
a wide margin,20,25 sedative-hypnotics are not the recommended treatment for chronic 
insomnia.3,26,27  
The state-of-the-science specifies that behavioral interventions, like cognitive 
behavioral therapy for insomnia (CBT-I), are the first line treatment.3,26,27 Studies 
within and outside the VA demonstrate that CBT-I significantly improves insomnia 
symptoms, nighttime sleep quality, and daytime function.28–30 CBT-I is a multi-component 
evidence-based psychotherapy that includes: stimulus control,31 sleep restriction,32 
cognitive therapy,33 sleep hygiene,34 and relaxation.35 CBT-I is typically 5-8 sessions (face 
to face [in-person or telehealth]) conducted by psychologists or other mental health 
providers.36 Randomized controlled trials and meta-analyses have established that CBT-I is 
effective in people with primary insomnia37 and those with comorbid insomnia,38 including 
psychiatric disorders (e.g., depression, anxiety)38–40 and medical disorders (e.g., chronic 
pain).41 A VA study, with nearly 700 Veterans, found that 60% who completed CBT-I 
achieved a treatment response (i.e., reduction ≥8 points per the Insomnia Severity Index 
[ISI]). These Veterans had a mean ISI change of 20.7 to 10.9, a large effect size (pre- to 
post-treatment Cohen’s d=2.3).29 In terms of long-term treatment gains, a recent review 
found 50% of patients responded to CBT-I and maintained treatment effects for 4-10 
years.42 CBT-I is also more effective than sedative-hypnotics at reducing sleep onset 
latency (SOL), and is equally effective at improving Wake After Sleep Onset (WASO) and 
sleep quality (SQ).43 It is important to note, combining CBT-I and sedative-hypnotics may 
not improve outcomes.44  
Deprescribing sedative-hypnotics is recommended, but deprescribing alone may not 
be enough. Deprescribing is the reduction or withdrawal of a medication managed by a 
healthcare professional that aims to reduce harm and improve outcomes.45 Sedative-
hypnotics are not the recommended treatment for insomnia3 and often result in more harm 
than benefit, especially for high risk groups such as older adults.46 Interventions to reduce 
sedative-hypnotic use range from patient-centered approaches (e.g., written instructions, 
relaxation strategies, therapy) to provider education and training.47,48 A typical intervention 
will involve gradual dose reduction (GDR), or tapering, and is sometimes accompanied by a 
psychological treatment, like CBT-I.48 Tapering approaches, including the use of 
telehealth,49,50 often involve dose reductions of 25-50% every 1-3 weeks until cessation is 
achieved.47 Cessation, however, has varying rates of success (27-80%). Adding 
psychological treatments (e.g., CBT-I) help reduce rebound insomnia and improve 
cessation rates compared to routine care (odds ratios: 3.38-5.96); however, the results of 
combining these methods has been mixed.50,51 Two key challenges to deprescribing are 
rebound insomnia symptoms and the lack of personalized care (e.g., brochures).52 
Considering these barriers and the prior research on CBT-I and sedative-hypnotic 
tapering,49 a personalized approach that can effectively combine CBT-I and deprescribing 
has promise to improve insomnia and sedative-hypnotic outcomes among Veterans. 
Access to deprescribing and behavioral interventions are necessary to provide 
maximum impact for Veterans. Access to care remains a barrier – especially for a 

 
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combined insomnia treatment approach. Sedative-hypnotic use is highly prevalent, with 
many chronic users.20–22,53 Although medication prescribers and clinical pharmacists can 
provide patient education and lead tapering efforts, they do not have training in behavioral 
insomnia interventions. CBT-I, despite the strong evidence to improve sleep quality and 
daytime function and with minimal adverse effects and long-term treatment gains,3 
continues to have limited availability. Even with significant training efforts by the VA, there 
is still a shortage of trained CBT-I clinicians, especially outside of urban VA Medical 
Centers. Additional barriers involve the location of CBT-I delivery, often in mental health 
clinics, which remains stigmatizing for many Veterans. CBT-I delivery can also be inflexible 
to meet the needs of many Veterans, requiring regularly scheduled visits (in-person or 
telehealth), which are not always possible for Veterans who work, have care taking 
responsibilities, or have transportation challenges. Considering the limitations to care due 
to the COVID-19 pandemic, access has changed. For some Veterans, greater access to 
care through telehealth has been beneficial. Flexible treatment solutions are required to 
provide optimal benefits for Veterans. Additionally, a novel, effective, and efficient 
telehealth option for deprescribing and improving sleep health and function can shift care 
towards telehealth for eligible Veterans and allow for increased in-person care for Veterans 
unable, unwilling, or not appropriate for telehealth.  
Digital sleep therapeutics offer personalized, efficient, effective, and scalable 
treatment for insomnia. However, there are no remote/digital interventions that combine 
personalized sedative-hypnotic tapering with CBT-I. Digital CBT-I platforms are available, 
including several developed by the VA, that have similar sleep outcomes as in-person CBT-
I.54 However, these platforms are solely self-management programs that focus only on 
improving insomnia symptoms. The Clinician Operated Assistive Sleep Technology 
(COAST) platform offers a personalized solution and can fill the gap for Veterans who can 
benefit from a combined approach to deprescribing and CBT-I. The COAST platform is a 
highly efficient and scalable digital health technology that is personalized and responsive to 
individual sleep behaviors.55,56 Data from the initial development trials and recent quality 
improvement data from military treatment facilities show COAST significantly decreases 
insomnia symptoms per sleep diaries and self-report measures to a greater extent than a 
recent in-person CBT-I trial with active duty military.57 COAST is built upon a patient facing 
mobile application and a provider dashboard. It offers safe, no-contact intervention in 
addition to prospective monitoring of patient-reported behaviors by a provider and assisted 
by the platform’s technology, and offers just-in-time, HIPAA-secure communication with the 
treatment team. COAST’s algorithms facilitate the detection of disordered sleep patterns, 
based on patient input, resulting in timely clinical decision making and personalized sleep 
interventions based on the core components of CBT-I. COAST’s efficiency helps to reduce 
clinician time involved in treatment to <60 minutes total per patient versus 30-60 minutes 
per session for in-person and telehealth modalities. COAST also promotes participant 
engagement58 and reduces burdensome aspects of face to face CBT-I by bringing tools 
and clinical expertise directly to the Veteran through their mobile device. 
COAST has been iteratively refined through testing with military personnel, Veterans, 
healthcare providers, and key stakeholders in the Department of Defense Military Health 
System and academic medical settings.56 While COAST’s focus is on behavioral sleep, the 

 
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platform is flexible and can integrate interventions such as sedative-hypnotic deprescribing. 
The existing secure communication feature also allows for rapid feedback for potential 
adverse effects of the deprescribing process. If scaled appropriately, digital interventions 
like COAST may help reduce chronic sedative-hypnotic use, improve sleep quality, and 
enhance functional outcomes. Furthermore, digital platforms like COAST are highly 
important considering the impact of COVID-19 on health and function and the need to 
maintain social distancing while still accessing high quality care. 
3.0 
Objectives 
• Study Objectives 
Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to 
participate in a 12-week combined deprescribing and CBT-I intervention, delivered 
through the COAST digital platform. 
Aim 2: To assess Veteran acceptability and usability of the COAST platform. 
Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to 
post-intervention. 
 
• Hypotheses 
H1: 
It will be feasible to recruit Veterans with chronic sedative-hypnotic use to participate 
in the intervention. 
H2: 
Veterans will find the COAST platform acceptable and usable. 
H3: 
Veterans will significantly improve their sleep behaviors and function and decrease 
their sedative-hypnotic use. 
 
• Relevance to Veterans 
Chronic insomnia and sedative-hypnotic use are prevalent among Veterans. This study will 
test a digital health platform, COAST, to deliver a combined intervention to (1) reduce use 
of sedative-hypnotics and (2) improve sleep behaviors using evidence-based behavioral 
interventions (CBT-I). If successful, this may offer an efficient and effective treatment for 
Veterans as an alternative to the current standards of care in VA. 
 
4.0 
Resources 
• VAPHS Resources 
The primary resource utilized will be VAPHS computing resources and office space. This is 
a telehealth study so research procedures, especially those involving participants, will be 
primarily remote (e.g., Veteran not physically located at VAPHS). The COAST clinician 

 
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portal is accessible via web browser, and this will be the primary method for participant 
engagement from study staff. This may take place at VAPHS (e.g., ROB, clinician office) or 
using VAPHS resources via telework (e.g., CAG/VPN, VA issued laptop, etc.). Other 
resources will include various OI&T resources and computing software to manage the 
study and conduct analyses. 
 
Participant data will remain confidential. Only approved study staff will have access to the 
study shared drive, located behind the VA firewall. Participant PHI (e.g., email, mobile 
device IP address) data will be collected via the COAST platform as will patient-reported 
outcomes (see 5.1); as needed, data may be collected directly via participant and the 
participant’s electronic health records and documented in the study database. Participants 
will enter data on their personal devices through the COAST mobile app. The study data 
analyst/statistician will ensure that all PHI is removed from the data prior to analyses.   
 
• Service Line Impact 
Co-Investigators, Drs. McQuillan and Spitznogle, are Staff Pharmacists, members of the 
Clinical Support Service Line; they have protected time to serve as Co-Is on this project. 
We also request support from service line leadership for recruitment in the form of a letter 
to Veterans who may be eligible based on inclusion/exclusion criteria. There is minimal 
service line impact, for assistance with recruitment, from Behavioral Health, Medicine 
(Sleep Medicine), and Primary Care.  
 
• Participant Payments 
Year 1 $4,125 
Year 2 $3,750 
 
Funds are requested as detailed below with payment occurring after completing each task. 
Payment will be made by electronic funds transfer or debit card. Payment is for time and 
effort engaging in the study procedures. 
 
Year 1 
Task 
# Participants 
Amount 
Total 
Baseline Assessment 
25 
$50 
$1,250 
Qualitative Interviews 
15 
$25 
$   375 
Post-Treatment Assessment 
25 
$50 
$1,250 
3-month Follow-Up Assessment 
25 
$50 
$1,250 
Year 1 Total 
$4,125 
 
 
 
 

 
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Year 2 
Task 
# Participants 
Amount 
Total 
Baseline Assessment 
25 
$50 
$1,250 
Post-Treatment Assessment 
25 
$50 
$1,250 
3-month Follow-Up Assessment 
25 
$50 
$1,250 
Year 2 Total 
$3,750 
 
• Off-Site Ancillary Activities 
A Statement of Work with NOCTEM Health, Inc has been established through the duration 
of the study. NOCTEM is a digital health technology company that developed the Clinician 
Operated Assistive Sleep Technology (COAST™) platform, built on evidence-based 
behavioral sleep practices, that provides efficient, flexible, and scalable delivery of 
behavioral sleep interventions. NOCTEM will provide a customized digital platform, 
COAST, to manage the collection of participant self-report data, which will be stored on 
HIPAA compliant, private, and secure servers; COAST is hosted on AWS GovCloud. 
NOCTEM will also provide all necessary technological support to the study team for 
COAST.  
5.0 
Study Procedures 
5.1 Study Design 
Assessments 
All patient-reported assessments will be conducted through the COAST platform. Additional 
data will be collected from participants’ VA medical records (e.g., diagnoses, medications, 
service connection, service utilization). Assessments will occur at baseline (T0/~T0+1week), 
post-treatment (T1), and 3-months post-treatment (T2) unless otherwise specified. 
Study feasibility will be assessed by recruitment and intervention participation. Response to 
recruitment letters (# responses / # letters mailed) will be assessed overall and for each 
stratified group (age, sex, race). Participation will be assessed by number of enrolled 
participants that activate the COAST app, complete baseline assessments, engage in 
treatment beyond the initial recommendation, and complete the intervention. 
COAST usability and acceptability will be measured with the Post-Study System Usability 
Questionnaire (PSSUQ).59 The PSSUQ measures perceived satisfaction with a “system” 
like a website or mobile app. The PSSUQ is 16-items, scored 1-7 (1-strongly agree, 7-
strongly disagree) or not applicable (N/A). The usability score is the average (total score 
divided by number of questions answered [N/A not included]). The three sub-scales are: 
usefulness (items 1-6), information quality (items 7-12), and interface quality (items 13-16). 
Lower scores, <3, indicate higher satisfaction and above average usability. The PSSUQ will 
be assessed at two time points. First, after the initial sleep/wake schedule recommendation 
is delivered (~T0+1 week) as this will give participants a chance to learn the COAST platform 
and second, at T1, to measure change over time.  

 
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To further assess usability/acceptability, 15 Veterans will be interviewed (e.g., phone, 
Teams, VVC) to gain context on their COAST user experience and potential changes or 
new features that could improve COAST. Veterans will be interviewed based on their 
PSSUQ scores to get a range of perspectives, if available, per score distribution (e.g., 5 
low, 5 medium, 5 high).  
The Insomnia Severity Index (ISI) will serve as the primary sleep outcome. The ISI is a brief 
measure of nighttime sleep disruption (e.g., severity of sleep onset) and daytime impact 
(e.g., interference with function).60 The ISI is 7-items (0-4) with higher scores indicating 
greater severity or impairment. Total score (0-28) is categorized: no insomnia (0–7); sub-
threshold (8–14); moderate (15–21); and severe insomnia (22–28). A reduction pre- to 
post-treatment ≥8 points indicate a treatment response and a post-treatment score ≤7 
indicate remission. The ISI will be assessed at T0, T1, T2 as well as weekly during 
treatment.   
Sedative-hypnotic medication will be measured by participant self-report, as part of a daily 
entry in COAST (e.g., “What sleep medication and dose did you take today?”). The daily 
COAST entry will also involve assessments for adverse effects and/or withdrawal 
symptoms (i.e., Clinical Institute Withdrawal Assessment – Benzodiazepines [CIWA-B]). 
Outcomes will include post-treatment (T1) medication dosage, relative to starting dose at 
baseline (T0), and binary outcomes of ≥50% reduction (yes/no) and total cessation (yes/no). 
Also, medication information from participants’ VA health records will be used to help 
validate their self-report of sedative-hypnotic use throughout the study. Additional 
information will be collected from the VA electronic health records (e.g., medical and 
psychiatric diagnoses, service utilization [e.g., insomnia-related care, behavioral 
health/sleep medicine appointments, sleep medicine pharmacy data]). 
Additional sleep outcomes will be measured with a daily sleep diary.61 Sleep diaries provide 
information about a participant’s sleep behaviors, such as bedtime, rise time, total time in 
bed (TIB), total sleep time (TST), sleep onset latency (SOL), number of nighttime 
awakenings (NWAK), duration of wake after sleep onset (WASO), and sleep efficiency 
(SE). Sleep diaries will be completed daily from baseline (T0) through post-treatment (T1) 
and for 7-days at 3-month follow-up (T2). Daily sleep diary data is used by COAST’s 
algorithms to generate personalized recommendations for each participant.  
Secondary clinical and functional measures will come from the Patient-Reported Outcomes 
Measurement Information System Adult Profile (PROMIS 29+2). It includes measures of 
Physical Function, Social Roles, Anxiety, Depression, Fatigue, Sleep Disturbance, Pain 
Interference, Pain Intensity, and Cognitive Function. Each construct is scored individually (4 
items, range 4-20) except Cognitive Function (2 items, range 2-10), with higher scores 
indicating more of the construct being measured. Raw scores are translated to a T-score 
with a mean of 50 and SD of 10. When all constructs are scored together, a preference 
score is calculated, representing health‐related quality of life ranging from 0 (as bad as 
dead) to 1 (perfect or ideal health).62 
 
 

 
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Screening 
• Via phone or video telehealth (e.g., MS Teams, VVC) to confirm inclusion/exclusion 
criteria 
Inclusion Criteria 
• VAPHS Veterans ≥18 years 
• Medical record documentation and self-report of active sedative-hypnotic use ≥3 
days/week for ≥3 months: z-drugs (zolpidem: ≤10mg IR, ≤12.5 SR; zaleplon: ≤20mg; 
eszopiclone: ≤3mg); trazodone (≤400mg); temazepam (≤30mg); hydroxyzine 
(≤100mg); Veterans on higher doses may be eligible on a case-by-case basis  
• A desire to reduce or stop using sedative-hypnotics 
• Access to a mobile device 
Exclusion Criteria 
• A self-report of a medical and/or psychiatric disorder that would significantly impair 
participation (e.g., cancer, uncontrolled pain, severe depression) 
• A self-report of a medical and/or psychiatric disorder that can be exacerbated by 
changes in sleep (e.g., seizure disorder, psychotic disorders, bipolar I disorder) 
• A self-report of an active substance use disorder 
• High risk of suicide per the Columbia-Suicide Severity Rating Scale (C-SSRS) 
• Currently engaged in an evidence-based, time limited, psychotherapy (e.g., prolonged 
exposure, cognitive processing therapy, cognitive behavioral therapy for depression, 
cognitive behavioral therapy for insomnia, etc.) 
 
Interventions 
Pharmacist-led Deprescribing 
This up-to 12-week intervention, sedative-hypnotic deprescribing integrated with CBT-I, will 
be delivered through the COAST platform.55 For the deprescribing intervention/taper, the 
study’s Clinical Pharmacist will develop a personalized taper for each participant based on 
their medication, dosage, and factors such as anxiety about the taper, duration of use, and 
insomnia severity (see Appendix—Deprescribing Summary for more information). The 
study’s CPPs will, as needed for the personalized taper, place appropriate orders for 
different doses and/or new medications in CPRS for the Veteran participant’s VAPHS 
prescribing provider to review/approve.  
As needed, the taper can be extended to 12-weeks, and if necessary, participants can be 
referred to their VAPHS prescribing provider for further deprescribing assistance after the 
intervention and post-treatment assessment is complete (T1). At any point during the 
intervention the taper can be paused if the participant is struggling to adjust or experiences 
withdrawal symptoms. All withdrawal symptoms will be reported through the COAST 

 
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platform and will be responded to within one business day by a study team member; 
outside of business hours (M-F, 0800-1630 EST), if necessary, participants can contact 
emergency services. The study’s CPPs will communicate the deprescribing plan to each 
participant through COAST’s secure messaging and the initial deprescribing plan will also 
be discussed verbally (e.g., phone, Teams, VVC).  
 
COAST Delivered CBT-I 
As deprescribing begins, so too will CBT-I through the COAST platform. The COAST 
algorithms, based on participant data (e.g., sleep diary, self-report measures), will generate 
treatment recommendations after approximately one week of participant data entry.56 
COAST’s treatment recommendations are based on the core components of CBT-I—
stimulus control, sleep restriction, cognitive therapy, and relaxation—with additional 
strategies targeting nightmares and daytime fatigue as needed. Weekly assessments and 
daily sleep diaries help the COAST algorithms make recommendations. A unique feature of 
COAST is that the study clinician must review and approve, or change, all 
recommendations before they are sent to the participant. This tailored approach allows for 
modification of COAST’s recommendations based on clinician expertise and knowledge of 
the participant (e.g., a recent stressor that indicates slowing or pausing treatment). To 
further enhance the treatment process, the clinician is available by secure message (i.e., 
in-platform texting) to provide rapid support and/or schedule an appointment as needed 
(e.g., phone, Teams, VVC). These features offer personalization for each participant, 
consistent with case-conceptualization based on Veteran’s sleep needs.  
The study clinician/Sleep Psychologist may be located at either VAPHS or the William S. 
Middleton Memorial Veterans Hospital (Madison VA). The goal of this research study is all 
interactions with study clinicians will be done remotely, primarily using the COAST platform, 
but as needed by video telehealth or telephone. However, if Veteran participants need to 
see a study clinician in-person, that visit will occur at VAPHS. For an in-person visit with a 
Sleep Psychologist, Veteran participants will see the Sleep Psychologist at VAPHS. 
The COAST recommendations are based on CBT-I and the rationale that modifying 
behaviors and cognitions impact the homeostatic and circadian drives. Modifying sleep and 
daytime behaviors helps regulate wakefulness, which can increase the homeostatic sleep 
drive, and restructures and optimizes sleep and wake times to reinforce the circadian drive. 
Modifying cognitions can help reduce worry that can result in the failure to inhibit 
wakefulness and contribute to physiological arousal.  
Stimulus control limits the bed to sleep and sexual activity only, which strengthens the 
association between bed and sleep. Staying in bed while awake and engaging in non-sleep 
activities perpetuates the cycle of wakefulness, frustration, and arousal. When unable to 
sleep, it is recommended to get out of bed and go to another room until sleepiness returns.  
Sleep restriction matches sleep opportunity, or prescribed time in bed (TIB), to average 
total sleep time (TST) so that the homeostatic and circadian drives can become better 
aligned. A consistent wake time is a) the most important cue for setting the biological clock, 
b) regulates exposure to morning light, and c) helps increase the homeostatic sleep drive 

 
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for subsequent nights. Going to bed only when sleepy, but not before a prescribed bedtime, 
increases the sleep drive and the likelihood of falling asleep quickly.  
Cognitive therapy helps to reduce nighttime stress and worry through the identification and 
challenging of dysfunctional beliefs. Learning strategies to overcome negative thoughts and 
promote positive attitudes can reduce racing thoughts at night and the wake/frustration 
cycle during awakenings.  
Relaxation strategies help reduce physical and cognitive arousal that can perpetuate 
wakefulness. Breathing exercises, guided imagery, and progressive muscle relaxation help 
to reduce arousal and feel ready to sleep. 
 
NOCTEM COAST 
The patient-facing app is available for iOS and Android: 
• https://apps.apple.com/us/app/noctem-coast/id1512674928 
• https://play.google.com/store/apps/details?id=com.noctem.coast&hl=en_US&gl=US 
 
The clinician portal is accessible through web browsers: 
• https://portal.noctemhealth.com/login 
 
Risks and Benefits 
 
Potential Risks 
The trial involves two interventions, sedative-hypnotic deprescribing and CBT-I, both of 
which are regularly delivered interventions to Veterans in the VA clinical environment. 
Deprescribing/withdrawal risk. Deprescribing is the reduction or withdrawal of a medication 
managed by a healthcare professional that aims to reduce harm and improve outcomes. 
Veterans regularly engage in deprescribing for a variety of medications, including sedative-
hypnotics, under the guidance of their health care providers (e.g., PCP, Clinical 
Pharmacist, etc.). When deprescribing sedative-hypnotics, rebound insomnia is common 
and expected. However, there is some risk for other withdrawal symptoms, which will be 
assessed daily (see below). For this study, deprescribing for each participant will be 
managed by study CPPs, licensed Clinical Pharmacy Specialists at VAPHS.  
The deprescribing of sedative-hypnotics, while a common outpatient procedure, does 
impose risks such as rebound insomnia, the potential for more serious withdrawal 
symptoms, and psychological discomfort. As noted above in the inclusion/exclusion criteria, 
we have limited the sedative-hypnotics in this study to z-drugs (i.e., zolpidem, zaleplon, 
eszopiclone), trazodone, temazepam, and hydroxyzine as these represent the most 
commonly used medications for insomnia at VAPHS. Veterans who use other prescription 
medications to improve their sleep will not be excluded from this study; however, only z-
drugs, trazodone, and temazepam will be targeted for deprescribing. Veterans who use 
over the counter medications for sleep will be managed on an individual basis. Also, for 

 
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Veterans taking zolpidem, trazodone, and temazepam at greater doses than is typically 
recommended,63 their inclusion will be determined on a case by case basis. Any Veteran 
excluded but still interested in reducing their use of sedative-hypnotics will be referred to 
their prescribing provider for assistance. The study’s CPPs will be responsible for the 
management of participants’ sedative-hypnotics, including collaborating with participants’ 
prescribing providers about who will enter the order in CPRS, communicating detailed 
instructions to participants and coordinating with them on the pick-up/delivery of 
medications, and, if necessary, the return of excess medication in higher doses. As 
needed, the study’s CPPs will utilize clinical tools at her disposal to assist with an 
individualized taper, such as the VA Academic Detailing Benzodiazepine Tapering 
Calculator located on the VA Academic Detailing SharePoint. 
Veterans will be assessed for withdrawal symptoms and psychological discomfort (e.g., 
irritable, restless, anxious, fatigue) on a daily basis as part of the daily sleep diary entry 
through the COAST platform. First, Veterans will be asked if they are experiencing any 
unexpected symptoms (other than increased trouble sleeping, which is expected with 
medication reduction)? If so, Veterans will be prompted to complete the Clinical Institute 
Withdrawal Assessment – Benzodiazepines (CIWA-B) for more detailed information. Any 
participant report of withdrawal symptoms, psychological distress, and adverse effects will 
be reviewed by the study staff daily (during weekdays). If symptoms are reported outside of 
business hours, Monday-Friday (0800-1630 EST), reports will be reviewed on the next 
business day. After review of symptom reports, the study Clinical Pharmacist and/or 
Clinical Psychologists will contact the Veteran through the COAST platform’s secure 
messaging to collect more information and provide feedback. As the study staff are only 
available during regular VA business hours (M-F, 0800-1630 EST), Veterans enrolled in the 
study will be instructed to contact emergency services if they ever feel they are 
experiencing emergent symptoms, study related or not. All Veterans will be provided the 
Veterans Crisis Line information as well. This approach to symptom management is similar 
to typical outpatient care at VAPHS.  
CBT-I risk. CBT-I is an evidence-based, multi-component psychotherapy regularly 
delivered within the VHA. CBT-I is the recommended first line treatment for insomnia per 
the VA/DOD Clinical Practice Guidelines, the American Academy of Sleep Medicine, and 
the American College of Physicians among other professional societies.12,25,40 Furthermore, 
there are several online and/or mobile app-based, self-management CBT-I interventions 
that have good evidence to improve symptoms with similar outcomes as in-person 
treatment.3 The CBT-I intervention delivered through COAST uses proprietary algorithms to 
develop personalized recommendations based on the patient-reported data from users. 
COAST treatment recommendations are always reviewed by providers prior to being 
delivered to the participant. For this study, Dr. Bramoweth (PI), a licensed psychologist with 
expertise in insomnia/behavioral sleep medicine, will review all COAST treatment 
recommendations prior to their delivery to participants and make changes based on clinical 
expertise and knowledge of each participant as needed.  
Suicide risk. Regarding suicidal ideation/behaviors, Veterans who are at high risk per the 
Columbia-Suicide Severity Rating Scale (C-SSRS) will be excluded and referred to the 

 
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appropriate resources following VAPHS guidelines. Specifically, Veterans with active 
suicidal ideation with intent and/or plan will be excluded. Veterans with ideation but no 
current intent or plan, but with a history of suicide attempts (including preparing for, 
interrupted, or aborted attempts) or self-injury in the past year will also be excluded. For 
Veterans who are eligible, those with suicidal ideation without method, plan, or intent will be 
monitored weekly with the C-SSRS through the COAST platform. If a Veteran meets 
elevated criteria for suicide risk (e.g., ideation with intent, plan, behaviors), they will be 
withdrawn from the study and referred for appropriate care per VAPHS guidelines.  
Breach of confidentiality. There is minimal risk of breach of confidentiality. All Veteran 
participants will be assigned a unique research ID in COAST; the only PHI collected via 
COAST is the participant’s email address and mobile device IP address, both of which are 
necessary for this study and this information will not be transferred to the PI/VAPHS as part 
of the regular data transfers. Furthermore, the study’s data analyst will ensure that all data 
received from COAST (see Data Sharing below) is deidentified and all PHI are removed 
prior to data review and analysis by the study team. In sum, the risks for Veterans are not 
considered to be different than risks associated with engaging in clinical care related to 
sedative-hypnotic deprescribing and/or engagement in CBT-I.  
This study will use the COAST platform to combine the clinical interventions of 
deprescribing and CBT-I to efficiently deliver treatment to participants in a remote manner. 
However, should any adverse events occur, they will be reported according to the VAPHS 
Human Subjects Research Reportable Events Guidelines. 
 
Protections Against Risks 
As noted above, we have plans in place to assess aspects of risk related to sedative-
hypnotic withdrawal and psychological discomfort, medication tapering and management, 
and suicide risk.  
Regarding protections against a breach of confidentiality, all data collected and obtained 
during the study will be confidential with access limited to approved study team members. 
Data collection and management will be conducted in strict accordance with the policies 
and procedures set forth by the VA Office of Research and Development. All participants 
will be assigned a unique ID that will be used throughout the study. COAST has several 
privacy and security measures in place (see Data Security below).  
 
Potential Benefits 
There is potential benefit for Veterans directly and VA broadly, as the reduction of sedative-
hypnotic use and the improvement of insomnia and sleep quality may improve Veteran 
function and clinical outcomes. These improvements can potentially improve overall 
Veteran health, function, and quality of life, and reduce utilization of VA health care 
services. The long-term objective of this proposal is to develop a larger clinical trial to test 
the effectiveness of the intervention in an appropriately powered and diverse sample. If 
effective and able to be broadly implemented in VA, there is potential to benefit Veterans 

 
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who use sedative-hypnotics to reduce their use of these medications, improve their sleep 
quality, and overall improve function, quality of life, and health. 
Veterans who engage in this deprescribing and insomnia intervention have the potential to 
directly benefit from improved function and sleep quality due to the impact of the 
intervention. Both deprescribing and CBT-I are evidence-based interventions. Secondary 
benefits may include the reduction of symptom severity of comorbid psychiatric disorders 
that are commonly linked with insomnia, such as depression, anxiety, and posttraumatic 
stress disorder; reduction of these symptoms may also improve Veteran function and 
quality of life.  
For Veterans who participate, they may have the opportunity to gain access to a treatment 
they may otherwise not have access to, a combined deprescribing and remote CBT-I 
intervention. Also, Veteran participants may benefit from participating as it allows them the 
opportunity to engage in research designed to help other Veterans, providing a sense of 
satisfaction knowing that they are contributing to improved Veteran function and health 
broadly. 
 
 
Alternatives 
Both sedative-hypnotic deprescribing and CBT-I are available treatments at VAPHS; 
however, they are typically available as separate treatments and not delivered via a digital 
platform. Participants interested in either interventions outside of participating in this study 
will be referred to the appropriate clinical service—their prescribing provider (e.g., PCP, 
Psychiatrist) for deprescribing and/or the Behavioral Health Service Line (Insomnia 
Consult) for CBT-I. The research team is not aware of other research studies that would 
provide a similar intervention.  
 
5.2 Study Population, Recruitment Methods, and Informed Consent Process 
Study Population/Inclusion and Exclusion Criteria 
Inclusion Criteria 
• VAPHS Veterans ≥18 years 
• Medical record documentation and self-report of active sedative-hypnotic use ≥3 
days/week for ≥3 months: z-drugs (zolpidem: ≤10mg IR, ≤12.5 SR; zaleplon: ≤20mg; 
eszopiclone: ≤3mg); trazodone (≤400mg); temazepam (≤30mg); hydroxyzine 
(≤100mg); Veterans on higher doses may be eligible on a case-by-case basis  
• A desire to reduce or stop using sedative-hypnotics 
• Access to a mobile device 
 
 

 
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Exclusion Criteria 
• A self-report of a medical and/or psychiatric disorder that would significantly impair 
participation (e.g., cancer, uncontrolled pain, severe depression) 
• A self-report of a medical and/or psychiatric disorder that can be exacerbated by 
changes in sleep (e.g., seizure disorder, psychotic disorders, bipolar I disorder) 
• A self-report of an active substance use disorder 
• High risk of suicide per the Columbia-Suicide Severity Rating Scale (C-SSRS) 
• Currently engaged in an evidence-based, time limited, psychotherapy (e.g., prolonged 
exposure, cognitive processing therapy, cognitive behavioral therapy for depression, 
cognitive behavioral therapy for insomnia, etc.) 
 
 
Inclusion of Women, Minorities, and Children 
Women and minorities will be included in this study. Children (i.e., under the age of 18) will 
not be enrolled in this study. Also, no prisoners or currently hospitalized Veterans will be 
enrolled. Veterans with severe and/or unstable medical/psychiatric illnesses will also be 
excluded from this study (see Inclusion/Exclusion Criteria above) as will Veterans at high 
risk for suicide. No exclusion criteria shall be based on race, ethnicity, gender, religion, or 
HIV status. 
 
 
 
Master List 
A master list of enrolled participants will be maintained. A Veteran is considered enrolled 
after completing the informed consent process. The master list will be stored on the secure 
VA study drive and only accessible by approved study staff.  
 
Recruitment Methods 
The goal is to recruit and enroll 50 Veterans from VAPHS and affiliated CBOCs. Rather 
than recruiting in clinic and in-person, as is common for intervention trials such as this, to 
expand the pool of eligible participants we will primarily recruit through mail. The study 
team will mail a letter (see Recruitment Letters) to potentially eligible Veterans, based on 
inclusion and exclusion criteria, utilizing data from Veteran medical records. These letters 
will be sent from service line leaders at VAPHS—Behavioral Health, Primary Care, and 
Medicine (representing Sleep Medicine). A pre-screen list of potentially eligible Veterans 
will be generated by the study’s data analyst, through VA’s Corporate Data Warehouse, 
and stratified by sex (male/female), race (White/non-White), and age (<65/≥65) as an 
attempt to recruit a diversified sample. Then, letters will be mailed weekly to potentially 
eligible Veterans randomly selected from each stratified group (e.g., ~20-25/group). Letters 
will be sent until the goal of 50 Veterans have been enrolled. 

 
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Letters will ask Veterans to call the study coordinator for more information or they can 
return a letter indicating their interest. Interested Veterans who contact the study team will 
then schedule an eligibility screen (e.g., phone, Teams, VVC) with the study coordinator. 
If feasible, depending on COVID-19 restrictions, recruitment will take place in VAPHS 
clinics (e.g., Primary Care, Behavioral Health, Sleep Medicine) in addition to the mail 
recruitment campaign. This may involve clinicians describing the study to their patients and 
providing study contact information as well as IRB approved fliers posted through VAPHS.  
As part of the proposal, a preparatory to research 
data query found VAPHS has n=1,455 Veterans 
who used sedative-hypnotic medications >14 
doses/month for ≥3 months from 01/01/2019 to 
01/31/2021 without diagnoses that would exclude 
them from participating. A new CDW query, using updated inclusion criteria, will update the 
pool of potential participants as of 1/31/2023. If feasible, depending on COVID-19 
restrictions, recruitment will take place in VAPHS clinics (e.g., Primary Care, Behavioral 
Health, Sleep Medicine) in addition to the mail recruitment campaign. Clinicians familiar 
with the study can also notify the research team of interested, potentially-eligible 
participants via a research specific CPRS consult, so that a study member can contact a 
Veteran directly. This will minimize the burden on the clinician and help recruitment in 
clinical settings be more efficient. 
 
Informed Consent Process 
Interested Veterans who respond to the letter recruitment (or other methods) will be 
scheduled to undergo a screen (e.g., phone, Teams, VVC, in-person [only if necessary]) to 
confirm inclusion/exclusion criteria. The study team will also review their electronic medical 
record to confirm aspects of inclusion/exclusion criteria. If eligible, they will be invited to 
undergo the informed consent process via remote procedures (e.g., phone, Teams, VVC) 
or in-person if requested. For remote consent, Veterans will sign the ICF + HIPAA using 
DocuSign. If in-person, the Veteran will complete a written ICF + HIPAA.  
Following consent, participants will be instructed on how to download the patient facing 
COAST app to their mobile device. Once downloaded, it will be activated with a unique 
code to prevent the app being used on another mobile device. Once the app is activated, 
the participants will be assigned a unique ID number, will undergo a brief training on how to 
use COAST, including instructions on how to access and navigate to the content areas, 
how to enter data for measures, how to use the sleep diary, and how to use the secure 
messaging. Previous testing of the COAST app by military Veterans and Service Members 
found its usability to be excellent and it received high scores for ease of use and 
learnability.55 Since the initial development, the user interface has been further improved to 
meet the needs of users. Also, any technical issues with the app will be rapidly responded 
to by the study/Noctem team. After the app training, participants can then complete the 
baseline assessment in the COAST app.  
 

 
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5.3 Data Analysis 
This study is focused on the feasibility of recruitment and participation, usability and 
acceptability of COAST, and estimates of change in Veteran sleep and sedative-hypnotic 
use. The findings from this SPiRE will inform the study design of a larger clinical trial (e.g., 
RR&D Merit). A meta-analysis of digital CBT-I (2016) found a hedge's g of 1.09 (95% CI 
0.74-1.45) when evaluating pre-post change on the Insomnia Severity Index (or similar 
measures).54 The only study, to date, using NOCTEM COAST found a pre-post Cohen d of 
1.93 for the ISI.56 While there are few studies specifically looking at CBT-I plus sleep 
medication deprescribing, they show large effect sizes for change on the ISI (Cohen d = 
1.98-2.26).49,64,65 Given the estimates from prior work conducted, we can expect an effect 
size range for pre-post ISI between 1.09 and 2.26 with an average effect size of 1.73 (large 
effect sizes). Given 50 recruited and accounting for a 25% drop out (i.e., 37 completers), 
we will still have 95% power to be able to detect an effect size of 0.65.  
Prior to analyses for each aim, participant characteristics will be evaluated with descriptive 
statistics (e.g., age, sex, race). Distributions will be examined for normality, outliers, and 
missing data. Continuous variables (means/SD) and categorical variables 
(frequency/percentage) will be reported.  
Aim 1. Feasibility will be evaluated in two ways. The first is by participant recruitment—how 
many participants contact the coordinator, undergo the study screen, and provide consent. 
The second is by treatment participation—how many participants download and activate 
the COAST app, complete baseline assessments, engage in treatment beyond the initial 
recommendation, and complete the intervention. Chi-square analyses will be used to 
determine group differences (age, sex, race) in recruitment response and participation 
rates.  
Aim 2. Usability and acceptability of COAST will be evaluated by the PSSUQ measure. 
Usability/acceptability will be measured early in treatment (T0+1-week) and at post-treatment 
(T1) as well as change over time (T1 – T0+1-week). Change will be assessed using an intent-
to-treat (ITT) approach and fitting mixed effects linear models that tests change in usability/ 
acceptability (change on PSSUQ scores over the course of treatment) that includes a main 
effect of time (T0+1-week to T1) and random effects for the Veteran.  
Audio-recorded qualitative interviews will help to gain more nuanced information on COAST 
usability/acceptability. The interviews will be interpreted using the rapid qualitative 
inquiry66,67 to ensure that results are delivered in a timely manner to be meaningful to the 
study. Interviews will be summarized by the study’s qualitative analyst into a template of 
categories that reflect topics of interest. The summaries will be coded by two analysts to 
develop the basis of content and thematic analyses.  
Aim 3. Veteran clinical and functional outcomes will be evaluated with an ITT approach. 
We will fit mixed effects linear models that test change pre-post treatment (ISI, sleep diary, 
PROMIS) that includes a main effect of time (T0-T1, T0-T2, and T1-T2) and includes random 
effects for the Veteran (multiple measurements during treatment). Sedative-hypnotic 
change will be a determined by an ITT approach and fitting a mixed methods logistic model 
that tests for dose reduction (≥50%, yes/no) and cessation of medication (yes/no) over the 

 
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course of treatment that includes a main effect of time (T0-T1, T0-T2, and T1-T2) and random 
effects for the Veteran. Additional analyses will compare completers vs. non-completers 
and responders vs. non-responders. 
The study data analyst/statistician will lead quantitative analyses and the study qualitative 
analyst will lead qualitative analyses. The PI and Co-Is will also be involved in study 
analyses and interpretation.  
 
5.4 Withdrawal of Subjects 
This study is voluntary, and participants may withdraw from the study at any time. If so, 
they may not be eligible for study payment depending on when they withdraw. Participants 
may withdraw from the study but may be eligible to continue in the follow-up assessments; 
if so, study staff will only communicate with the participant to schedule and complete the 
follow-up assessments. 
If it becomes known that a participant meets exclusionary criteria (e.g., high risk for suicide, 
active substance abuse), they may be withdrawn from the study. 
If a participant chooses to begin a new sedative-hypnotic or increases a dose of a sedative-
hypnotic that is not part of the study’s Clinical Pharmacist taper plan, they may be 
withdrawn from the study. 
If a participant chooses to begin a new evidence-based psychotherapy, they may be 
withdrawn from the study.  
If a participant withdraws or is withdrawn, with their permission, current sedative-hypnotic 
information and taper plan will be communicated to their prescribing provider. 
6.0 
Data Safety Monitoring 
A data and safety monitoring plan will be implemented to ensure that there are no changes 
in the benefit/risk ratio during the study and that confidentiality of research data is 
maintained. The PI, investigators, study personnel, and the clinical coordinators involved in 
the study will meet at least monthly to discuss the study (e.g., study goals, progress, 
modifications, documentation, recruitment, retention, data analysis and confidentiality) and 
address any issues or concerns at the time. These meetings will be overseen by the PI. 
Any instances of adverse events, protocol deviations, or other problems identified during 
the meetings will be reported as soon as possible within the required reporting timeframes 
using the standard forms and/or procedures set forth by the IRB. In addition, clinical 
coordinators may review study documentation and/or consent forms to ensure that 
participant’s confidentiality is maintained. 
This study does not have a DMC or DSMB.   
 

 
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7.0 
Privacy and Confidentiality 
PHI will only be disclosed for necessary study procedures, including recruitment via a CDW 
data query for VAPHS Veterans who may be eligible (only accessed by study data analyst) 
and as needed for the informed consent process and for participant payments. 
All participants will have unique research ID numbers that will be used in lieu of PHI (e.g., 
names, date of birth, SSN, etc.) for data collection and storage. The research ID numbers 
are unrelated to any potentially identifiable numerical series, such as social security 
number, medical record number, or date of birth. Study data will be kept strictly confidential, 
and participants’ identities will not be revealed in any publication. Electronic data collected 
via COAST will be reviewed for completeness and uploaded into the study database at 
NOCTEM. Both NOCTEM AWS GovCloud-based databases and VA databases are 
protected by several procedures, including password protection and a firewall around the 
networks. 
Data collected by NOCTEM via COAST will be transferred to the PI/VAPHS. After 
participant enrollment, data collection will primarily be through COAST and managed by the 
NOCTEM team; interview data will be conducted by study staff using approved methods 
(e.g., digital audio recorder, MS Teams, audacity). There will be a regular (e.g., quarterly) 
data review and a secure data transfer between NOCTEM and VAPHS. Once data is at 
VAPHS, the PI will oversee aspects of data management with support from the study data 
analyst. VAPHS databases and necessary data entry forms will be developed by study data 
analyst and data will be stored on a VA server maintained by OI&T in a study-specific 
shared drive with access limited to the VAPHS study team.  
All research data will be stored according to the VA Record Control Schedule. 
Data collected in this study, if approved by the participant, will be stored in a repository 
(VAPHS Research Repository (MIRECC)). However, data will not be used in other studies 
unless using approved VAPHS ORD guidelines (e.g., new IRB protocol; approval by 
repository PI).  
8.0 
Collaborative/Multisite Research 
VAPHS is the primary research site and will also serve as the coordinating site. The Madison 
VA (Co-I, Lickel) will serve as the participating site. To facilitate communication, an MS Teams 
will be created for the SEDATIVE study so all team members can be kept up to date for all 
study procedures. This included ensuring the study protocol is followed and to avoid any study 
non-compliance; any non-compliance that occurs will be reported in accordance with VHA 
Directive 1058.01.  
The study will utilize a VAPHS shared drive (R:\Bramoweth_1638783_SEDATIVE) to ensure 
document version control; Madison VA will not have a separate study drive. This will also 
prevent data from being stored at multiple study sites, further protecting study data per VA 
information security policies.  
Similarly, all IRB approved study documents (e.g., ICF, HIPAA, IRB/R&D approval) will be 
available on the study shared drive and IRBNet. Prior to the initiation of any study procedures, 

 
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the PI will ensure that all approval documents, from VAPHS and Madison VA, are up-to-date. 
For any amendments, a similar procedure will take place, with the PI ensuring that all 
approved documents are in place at both sites.  
Should any serious adverse events (SAEs) occur, they will be documented on the adverse 
events log (shared drive) and reported according to VA ORD policies. Study investigators, at 
both participating sites, will be notified as well.  
If VAPHS (IRB of record) determines that Madison VA is NOT to be engaged in research, the 
PI will inform Dr. Lickel, who will inform his local facility Director, who has the authority to 
approve/disapprove the conduct of research activity. Furthermore, when Madison VA no longer 
needs to be engaged in research, the PI will inform Dr. Lickel.  
 
 
 

 
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9.0 
References 
1.  Troxel WM, Shih RA, Pedersen E, et al. Sleep in the Military: Promoting Healthy Sleep 
Among U.S. Servicemembers. RAND Corporation; 2015:1-282. 
http://www.rand.org/pubs/research_reports/RR739.html 
2.  Mysliwiec V, McGraw L, Pierce R, Smith P, Trapp B, Roth BJ. Sleep disorders and 
associated medical comorbidities in active duty military personnel. Sleep. 2013;36:167-
174. doi:10.5665/sleep.2364 
3.  Mysliwiec V, Martin JL, Ulmer CS, et al. The Management of Chronic Insomnia Disorder 
and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs 
and U.S. Department of Defense Clinical Practice Guidelines. Ann Intern Med. 
2020;172(5):325. doi:10.7326/M19-3575 
4.  Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA. Mild traumatic brain 
injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008;358:453-463. 
doi:10.1056/NEJMoa072972 
5.  Kyle SD, Espie CA, Morgan K. “… Not Just a Minor Thing, It Is Something Major, Which 
Stops You From Functioning Daily”: Quality of Life and Daytime Functioning in Insomnia. 
Behav Sleep Med. 2010;8(3):123-140. doi:10.1080/15402002.2010.487450 
6.  Sarsour K, Van Brunt DL, Johnston JA, Foley KA, Morin CM, Walsh JK. Associations of 
nonrestorative sleep with insomnia, depression, and daytime function. Sleep Med. 
2010;11(10):965-972. doi:10.1016/j.sleep.2010.08.007 
7.  Espie CA, Pawlecki B, Waterfield D, Fitton K, Radocchia M, Luik AI. Insomnia symptoms 
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