Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income Populations
Phase: NA
Conditions: Sleep
Sponsor: Brigham and Women's Hospital

COVER PAGE 
 
Documents 
Detailed Protocol and Statistical Analysis Plan 
 
Study Title  
Phase 3: Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income 
Populations 
 
Date Modified  
2/5/2018 
 
IRB Approved 
2/16/2018 
 
NCT Number  
NCT03392194 

DETAILED PROTOCOL 
Adapting Sleep and Yoga Interventions for Maximal Effectiveness in Low Income 
Populations: Phase 3 
Version 2 
Principal Investigator: 
 
Susan Redline, MD, MPH 
Brigham & Women’s Hospital 
Division of Sleep Medicine 
221 Longwood Ave, Room 225 
Boston, MA 01225 
617-732-5859 
 
 
 

Table of Contents 
I. 
Background and Significance (including progress report and preliminary 
studies).  
a. Historical background 
b. Previous studies leading up to and supporting the proposed research 
c. Rationale behind the proposed research, and potential benefits to patients and/or 
society 
II. 
Specific aims (research objectives) 
a. Specify objectives and hypotheses to be tested in the research project 
III. 
Subject selection 
a. Inclusion/ exclusion criteria 
b. Source of subjects and recruitment methods 
IV. 
Subject enrollment 
a. Methods of enrollment, including procedures for patient registration and/or 
randomization 
b. Procedures for obtaining informed consent (including timing of consent process) 
c. Treatment assignment, and randomization (if applicable) 
V. 
Study Procedures 
a. Study visits and parameters to be measured (e.g. Lab tests, x-rays, other testing) 
b. Drugs to be used 
c. Devices to be used 
d. Procedures/ surgical interventions, etc. 
e. Data to be collected and when the data is to be collected 
VI. 
Biostatistical Analysis 
a. Specific data variables being collected for the study (e.g. data collection sheets) 
b. Study endpoints 
c. Statistical methods 
d. Power analysis (sample size, evaluable subjects, etc.) 
VII. 
Risks and Discomforts (stratify by common and uncommon) 
a. Complications of surgical and non-surgical procedures, etc. 
b. Drug side effects and toxicities 
c. Device complications/malfunctions 
d. Psychosocial (non-medical) risks 
e. Radiation risks  
VIII. 
Potential Benefits 
a. Potential benefits to participating individuals 
b. Potential benefits to society (e.g., increased understanding of disease process, 
etc.) 
IX. 
Monitoring and quality assurance 
a. Independent monitoring of source data 
b. Safety monitoring (e.g., Data safety monitoring board, etc.) 
c. Outcomes monitoring 
d. Adverse event reporting guidelines 
X. 
References 
 
I. Background and Significance (including progress report and preliminary studies).  
Sleep problems, characterized by short sleep duration or poor quality (termed “inadequate 
sleep”), not only cause distress, reduce well-being, and impact cognition, but also are significant 
risk factors for chronic pain as well as for incident depression, cardiovascular disease, stroke, 

diabetes, obesity, cancer and for premature mortality. Inadequate sleep is highly prevalent in 
minority and low-socioeconomic (SES) populations who also are at increased risk for multiple 
chronic diseases. Thus, inadequate sleep may serve as an important mediator of health 
disparities. 
Inadequate sleep is often attributable to and perpetuated by poor sleep hygiene (nighttime 
behaviors and environments that impair sleep) and/or to hyper-arousal (inappropriate central 
nervous system activation secondary to stress).  As such, fundamental to improving sleep is the 
practice of core elements of sleep hygiene as well as use of behavioral strategies that reduce 
arousal. Extensive research has established the efficacy of mind-body behavioral interventions, 
including yoga, for reducing stress and hyper-arousal. Furthermore, members of our team and 
others have generated data supporting the efficacy of yoga for improving sleep. However, there 
has been sparse research on adapting and evaluating behavioral interventions for sleep for 
minority and low-SES groups who have a high prevalence of inadequate sleep; in particular, 
modifying the content and delivery of these therapies to fit the social context in which these 
populations live and work has been sorely neglected.  
Our prior work, detailed in the following paragraph, allowed us to to develop and adapt a 
sleep health promotion and yoga intervention for use in a low-SES urban population who have a 
high prevalence of inadequate sleep. We now propose to conduct a  randomized controlled trial 
(RCT) to compare a sleep hygiene (SH) intervention to an intervention that combines sleep 
hygiene with a yoga (Y) intervention, with the objective of reducing stress and arousal and to 
improve sleep quality and extend sleep duration. The ultimate objective is to generate high level 
evidence to guide the use of sleep hygiene and yoga interventions for improving sleep duration 
and quality, and thus for improving health and well-being in under-served populations. 
  
In year one, during our Phase 1 work, we conducted qualitative research to investigate 
beliefs and understandings around sleep, sleep hygiene, and yoga, as well as to better 
understand barriers and opportunities to improve sleep through sleep hygiene and yoga. We 
conducted two focus groups with 16 adult participants and 3 key informant interviews. 
Participants were recruited from member residents of the Roxbury Tenants of Harvard (RTH) 
association, a low-income housing association in Boston. We recently published findings from 
Phase 1 (http://www.sciencedirect.com/science/article/pii/S1744388117302967); these findings 
were used to develop a culturally appropriate and effective pilot intervention for the second 
phase of the study   In Phase 2, we conducted pilot testing of our adapted SH and Y 
interventions. Quantitative and qualitative assessments were used to assess feasibility, 
acceptability, and intervention usefulness. The two pilot interventions were adapted for our 
target population, to promote intervention uptake and adherence and to increase the likelihood 
of success of a future trial. Participants were recruited from RTH for the first pilot (n=15) and 
participants were recruited from Mission Main housing for the second pilot (n=8).   Findings in 
Phases 1 & 2, informed the protocol and intervention materials for Phase 3. This Phase 3 study 
will consist of a 40 person, 12-week feasibility trial. We will randomize adults with short sleep 
duration to SH versus SH+Y interventions.  Outcome measures include the uptake, feasibility, 
and adherence to the intervention, as well as the short-term effects on sleep duration and 
potential mediators.   
Importance of Sleep for Health and Well Being.  Sleep is now understood to play a 
fundamental role in multiple aspects of health and wellness, including mental health; 
cardiovascular, metabolic, and neuroendocrine physiology; and pain, vitality, and quality of life.  
Sleep curtailment has been shown to adversely impact the hypothalamic-pituitary-adrenal axis; 
reduce clearance of cortisol; alter secretion of vasoactive hormones and blood pressure control; 
and to adversely influence appetite-regulating hormones, insulin sensitivity, and inflammation.   

Sleep curtailment results in impaired vigilance and altered mood, increasing negative affect, 
irritability, anger, and stress, and enhancing sensitivity to pain.  Curtailed sleep impairs the 
ability of the brain to clear toxic metabolites, providing a mechanistic link between sleep 
deprivation and dementia.  Prospective studies have shown that inadequate sleep duration 
and/or quality are risk factors for incident and recurrent major depressive episodes; incident 
obesity, diabetes, cardiovascular disease and premature mortality. The public health burden of 
sleep disturbances is also evident by associations with increased health care costs. These 
significant health concerns and their impact on the health care system motivated the Joint Task 
Force of the Sleep Research Society and American Academy of Sleep Medicine to recommend 
research that develops and tests interventions for improving sleep in the population, particularly 
in low-SES groups at high risk for sleep problems and their attendant co-morbidities. The 
current proposal aims is to conduct the foundational research needed to address this research 
gap. 
Sleep Duration and Quality. There are multiple dimensions of sleep relevant to health, 
including sleep duration, sleep architecture, and sleep disturbances (both perceived and 
objectively measured). Sleep duration and quality are influenced by sleep behaviors (e.g., 
activities surrounding bedtime, sleep schedules), primary sleep disorders (e.g., sleep apnea; 
primary insomnia); and co-morbidities (e.g., depression; COPD, etc.). We highlight sleep 
duration as a fundamental target for improving sleep in the community, noting that improving 
sleep duration is a Healthy People 2020 goal, as well as a cornerstone of most sleep 
interventions regardless of etiology of the sleep disturbance (e.g., for sleep apnea, CPAP 
efficacy requires nightly CPAP use patterns that depend on adequate sleep duration). Since 
short sleep duration (<6-7 hours/night) is found in approximately 40% of the adult population, 
this approach addresses a common deleterious health behavior. Since risk factors for 
inadequate sleep duration overlap with those for poor sleep quality, our proposed interventions 
address not only sleep duration, but also sleep quality. We will specifically target two major 
contributors to inadequate sleep: a) poor sleep hygiene (bedtime practices that impair sleep) 
and b) hyper-arousal (inappropriate central nervous system activation secondary to stress, 
resulting in insomnia symptoms: problems falling asleep, maintaining sleep and early morning 
awakenings).  Given the associations among sleep and multiple health parameters, 
interventions for fundamentally improving sleep should provide an effective strategy for 
improving multiple dimensions of health and well-being. 
Sleep Problems Disproportionately Afflict Low-Income and Minority Groups. 
Inadequate sleep, including longer sleep latency and shorter sleep duration, is prevalent among 
low-SES and racial/ethnic minorities groups, and likely reflects the influence of a number of 
chronic stressors: occupational and financial strain, discrimination, contextual (e.g., 
neighborhood) factors, as well as the effects of anxiety and depression. The disproportionate 
burden of inadequate sleep in minority groups is evident in data from the Multiethnic Study of 
Atherosclerosis (MESA). In a MESA sleep ancillary study that we conducted using actigraphy 
and polysomnography in 2200 MESA participants, adjusted analyses indicated that African 
Americans had a 5.01 (95% C.I.: 3.67, 6.84) increased odds of short sleep (<6 hours) and a 
1.78 (1.15, 2.75) increased odds of low sleep efficiency (<85%) compared to whites; insomnia 
symptoms were reported by 25% of African Americans and 26.5% of Hispanics. Additionally, the 
high burden of inadequate sleep in minority groups likely contributes to their disparate burden of 
disease. For example, data from NHANES indicate that blacks are at risk of more severe 
consequences, such as diabetes, from disordered sleep compared to non-Hispanic whites. 
Despite the abundant epidemiological data quantifying the high prevalence of inadequate sleep 
in minority and low-income groups, there has been scant research aimed at adapting and 
testing interventions to improve sleep in these high-risk population groups. Since low-SES 

groups often experience multi-level psychosocial, family, neighborhood, and occupational 
stressors, there is a need to tailor sleep interventions to be feasible for individuals facing 
multiple, chronic stressors and adverse sleeping environments. There are also opportunities to 
build upon the strengths of the community, such as the strong role of spirituality, and its role as 
a stress buffer and source of resiliency. Thus, for Phase 3, we propose to test a socio-
contextually appropriate community-based sleep intervention that proves to be a durable 
approach for improving sleep quality and duration, and thus for alleviating recalcitrant health 
disparities.  
Sleep Interventions. Behavioral sleep therapies, delivered as single or multi-modality 
interventions, are efficacious in improving sleep in patients with sleep disorders managed in 
clinical settings. However, such therapies have not been adapted nor tested for use in more 
general populations or in community settings. Our preliminary work with residents in low-income 
Boston housing has identified a high prevalence of poor sleep hygiene as well as chronic and 
daily stress; thus, supporting the need for community-based interventions that jointly address 
the inter-connecting influences of poor sleep and stress. We posit that a yoga intervention will 
improve sleep by positively influencing stress responses, affect, resilience, and self-efficacy, 
resulting in: a) improved adherence to sleep hygiene recommendations; and 2) reducing 
physiological arousal, a key mechanism for initiation and perpetuation of insomnia symptoms.  
In summary, inadequate sleep is highly prevalent in low-SES and minority groups and 
associated with multiple health problems. The root causes of inadequate sleep are often related 
to behavioral practices and stress, both of which may be favorably impacted using socio-
contextually appropriate sleep hygiene recommendations and mind-body practices such as 
yoga. We will conduct a preliminary RCT that will address the role of sleep behavioral 
interventions in a high-risk community. This evidence is needed to guide mind-body therapies in 
low-SES communities in which such strategies are under-utilized to improve health. 
 
II. Specific aims (research objectives) 
We have assembled a multidisciplinary team of experts in sleep medicine, complementary 
and integrative health, behavioral medicine, community engagement, social epidemiology, and 
clinical trials to conduct a planning study to adapt behavioral sleep interventions for residents in 
urban low-income housing and to evaluate their uptake and fidelity. In Phase I, we conducted 
qualitative formative evaluation work. In Phase 3, we will deliver a 12-week RCT testing the 
feasibility of (1) an adapted sleep hygiene intervention and (2) yoga + adapted sleep hygiene 
intervention.  
A. A Sleep Hygiene (SH) Intervention, addressing: beliefs and attitudes towards sleep; 
challenges for adhering to sleep hygiene recommendations given chaotic family 
routines, work schedules and bedroom conditions; strategies for overcoming barriers, 
such as positive affirmation, at-home diaries, social support; environmental changes that 
facilitate the right choices for good sleep (“choice architecture”); and prioritization of 
recommendations most likely to be efficacious. 
B. A Yoga (Y) Intervention, reflecting feedback from our focus group participants on: 
intervention intensity/duration and class format; tailored home-based recommendations 
for bedtime practice combining meditation, breathing and postures; tools to assess and 
enhance adherence; race/ethnicity concordance of the instructor and student; and use of 
peer yoga assistants. 
 

Aims 1 and 2 of the study are to conduct a 40 person 12 week RCT of SH vs SH-Y to inform 
the design of a future large scale RCT.  
 
The main goals of aim 1 are to evaluate the feasibility of recruiting from our target community, 
randomizing individuals to interventions delivered in community rooms with home-based 
practices, and delivering the targeted interventions with high adherence and fidelity. We will 
evaluate the:  
• 
Reach of the target population: The number of potentially eligible individuals approached 
to participate will be tracked as well as the characteristics of individuals who do and do 
not choose to participate, and differences will be assessed. Reasons for choosing not to 
participate will be assessed using open ended questions (e.g., burden, perception of 
yoga, needs, etc.).  
• 
Adoption and adherence: We will assess the proportion of individuals that sustain 
participation throughout the intervention, and quantify attendance at classes and home-
practices through logs and interim phone interviews. We will describe patterns of dropout 
rates and adherence to the interventions by key demographic factors and by moderating 
and mediating factors.   
• 
Implementation-consistency of delivery of the intervention: We will use a checklist of 
core intervention elements documenting the degree to which core elements of the 
intervention was delivered as specified in the protocol.   
Aim 2 goals also are to assess the feasibility of collecting a range of baseline, outcome, process 
and mediator data and to generate data to support use of specific measures in a later trial, 
including patterns of missingness of data, distributions of data, correlations between outcomes, 
baseline factors and mediators, and evaluation of “dose-response” associations between time in 
intervention and sleep duration and efficiency. We therefore will evaluate:  
 
III. Subject selection 
a. Inclusion/ exclusion criteria: 
Inclusion Criteria: 
• 
Ages 18-75 years old 
• 
Verbally proficient in English 
• 
Self-reported average (over the prior month) weekday sleep duration of < 6 hours 
• 
Reside in a Boston public housing unit in the Mission Hill area  
Exclusionary conditions:  
• 
Severe physical conditions preventing participation in yoga, including major surgery 
or head injury in the prior 3 months, or unstable vertebral injury with inability to sit or 
lie down for 5 or more minutes; or glaucoma 
• 
Major psychiatric disease (e.g. schizophrenia, depression, PTSD) requiring 
hospitalization in the last year; or disease severity that, in the opinion of the 
investigator, would make it difficult for the participant to partake in the study 
activities.    
• 
Severe sleep disorders: self-report of physician diagnosed insomnia requiring 
hypnotics more than 2X/week. 
• 
Needing an assistive device such as a walker or cane, frequent falls, history of stroke 
resulting in weakness or numbness interfering with moving easily, or other problems 
causing ongoing balance issues and difficulty walking 

• 
Yoga class participation in last 6 weeks 
• 
Known pregnancy.  
 
Recruitment: A total sample of 40 subjects will be recruited for the 12-week RCT pilot, with 20 
participants in each arm. Recruitment materials (flyers, brochures, letters/ mailings) will be 
distributed by a study coordinator, community partners and residential coordinators. In addition, 
we will send an opt-out letter and call participants. An opt-out letter with a brief explanation of 
the study will be sent to residents by residential coordinators. Residents who do not opt-out may 
receive a phone call from study staff with more information about the study. If interested, they 
will be screened for eligibility. Eligible candidates can then choose if they wanted to be 
consented to enroll in the study. We will purposively recruit participants for characteristics of 
interest to ensure representation from different racial/ethnic groups and gender. Individuals will 
undergo a brief phone or in-person interview to determine initial eligibility (with a HIPAA waiver). 
Eligible candidates will be invited to a consent visit. Eligible participants will then determine if 
they want to consent to enroll in the study.  
 
b. Source of subjects and recruitment methods 
Source of subjects: Participants will be recruited from low income Boston housing units in the 
Mission Hill area, namely Roxbury Tenants of Harvard and Mission Main. Since 1969, RTH has 
served as a multi-purpose, resident-controlled neighborhood, non-profit corporation, 
representing community residents for over 40 years. Mission Park, the main residential 
complex, has 775 units with 1,293 residents who mirror the diverse neighborhood in which they 
reside (17% Black, 29% Latino, 38% Asian, and 13% White [primarily immigrants]).  Mission 
Main owns and manages 535 units of rental housing, with a mixture of 83% public housing units 
at 17% market rent. Our pilot work was successfully conducted in both housing units, and 
supported by housing peer leaders and coordinators. 
 
IV. Subject enrollment 
a. Methods of enrollment, including procedures for patient registration and/or 
randomization 
The study coordinator will contact potential participants to conduct a short screener to assess 
eligibility and interest in participating (with a HIPAA waiver). The screener includes questions on 
average sleep duration (inclusion criterion), selected medical conditions and prior 
hospitalizations and other questions addressing exclusionary conditions, including use of 
hypnotic medications. Careful tracking of refusal rates and eligibility status will describe 
recruitment yields by gender and race. After eligibility screening and consent, each participant 
will be randomized into one of two conditions: the sleep hygiene condition or the sleep hygiene 
plus yoga condition.  
b. Procedures for obtaining informed consent (including timing of consent process) & c. 
Treatment assignment, and randomization (if applicable)  
Written informed consent will be obtained following the initial screening procedure and before 
collection of formal questionnaire and objective data at BWH (221 Longwood Ave), BWH’s 
Wellness Center, RTH community room, or Mission Main Offices. Following consent, 
participants will begin the baseline assessment. They will complete baseline questionnaires, 
and be randomized to one of two interventions using a customized web-based randomization 
module (www.slice.partners.org). Participants will receive an actigraph and actigraphy diary to 

track sleep for 1-week. The joint consent-baseline visit is estimated to take maximum 90 
minutes.  
 
V. Study Procedures 
a. Study visits and parameters to be measured (eg. Lab tests, x-rays, other testings) 
 
Participants will attend several study visits.  
Research visits  
All participants will be asked to attend 2 research visits: a baseline and follow-up visits. 
Research visits will occur at the RTH community room, or Mission Main Offices. 
To begin, participants will be screened for participation over the phone. Participants will then 
meet with a trained research staff to complete written informed consent. Following consent, 
participants will be administered questionnaires, undergo several physical measurements, and 
be instructed on use of wrist actigraphs and 1-week actigraphy diaries.  We estimate this visit 
will take 90 minutes. Participants will return their actigraphy diaries and actigraphs 
approximately one week later. The final research visit will be a follow-up endpoint visit to repeat 
measures. Study staff will repeat anthropometry and questionnaires. We estimate this visit will 
take 60 minutes. We will make every attempt to re-study all individuals at the 12-week visit, 
regardless of adherence to interventions. Actigraphs and actigraphy diaries will be distributed 
for participants to wear and complete for 1 week. 
Intervention visits  

Participants in both arms will attend two SH group sessions led by a sleep expert. The first one 
will focus on sleep hygiene education. The second visit, one week later, will allow participants to 
check-in about their goal setting and trouble-shoot in a socially supportive setting. Both groups 
will receive 2 interim phone calls to review SH progress and assess sleep quality. The staff 
member making the call with review the participants’ sleep logs prior to speaking with the 
participant to inform the conversation. The staff member will attempt to contact participants up 
to 3 times and the answer rate will be documented. The SH+Y arm will attend 8 in-person 
beginner yoga classes after the SH-group visits. They will receive materials (handbook, audio 
recordings, yoga props) to support the at-home yoga practice for the following 10 weeks; the 
final 2 weeks will provide the researchers with insight into the short-term sustainability of yoga 
home practice.  
For both groups, interim phone calls are made at 4-5 and 8-9 weeks to reinforce participation, 
collect information on study process measures (yoga practices; SH), assess self-reported sleep 
duration, and ascertain adverse events.  
The measurement schedule and questionnaire names are outlined in the study timeline graphic 
that appears above. Measurements will solicit demographic and health history information. 
Information on outcomes related to the intervention will be collected (sleep quality, sleep related 
impairment, sleep knowledge and beliefs). Questionnaires will also provide information on 
potential mediators such as anxiety, mood, stress response, self-efficacy and mindfulness. 
Participants will also receive a sleep log (SH arm) or sleep and yoga log (SH-Y arm), asking 
them to record their daily sleep times, sleep related behaviors (and time spent in yoga). 
Participants will complete the log daily for the entirety of the intervention. The log will provide 
information for researchers on sleep habits and home-yoga practice; in addition, the log 
promotes the intervention behavior change goals, functioning as a self-monitoring tool.  
 
Finally, at the end of the intervention, participants will be asked to complete a questionnaire that 
will ask about acceptability and effectiveness of specific components of the SH and yoga 
interventions, respectively for the SH and SH+Y arms. Surveys also will include questions 
related to the clarity and acceptability of the intervention materials including message attention, 
processing, comprehension and perceived ability to complete the suggested behavioral 
modifications and burden. Barriers to implementation and suggestions for further adaptation will 
be solicited, in addition to information on how participants’ health habits and mood may have 
changed.  
 
Participants will be invited to 1-2 focus groups to gather a broader range of qualitative data from 
the target population that will aid in the refinement of a future protocol.  
 
Dosing: We will plot self-reported sleep duration (reports from self-reported data) to explore 
sleep duration vs time dose-response relationships (linear trends, thresholds, plateau in 
response). 
 
Ongoing contact: Research staff will maintain telephone and text message (SMS) contact with 
participants across the study period, providing appointment reminders to reinforce the protocol 
and interventions and to answer questions. Participants will be contacted through SMS software 
(e.g. “Red Oxygen”). The text messages will not contain PHI (see RISO approval letter). 
Participants will also have the option to opt-in to receiving an SMS at their choice interval 
reminding them to complete a sleep diary and to practice yoga at home. Participants will be 
asked to contact staff should they experience change in health, accidents, or injuries over the 

course of the intervention period (i.e., soliciting information on possible adverse events) and to 
report possible problems to research staff at each study visit. 
Data Collection.  Research staff will be trained and certified in all study procedures and will 
oversee or directly administer surveys following a standardized protocol. All forms will use a de-
identified tracking number. The only linkage with the de-identified number and participant name, 
address, and other contact information will be in a recruitment log maintained securely by the 
research coordinator. 
Interventions: Sleep 
Hygiene (SH) Intervention: 
Initially based on studies of 
the effects of caffeine and 
alcohol on sleep and on 
clinical observations of 
patients with poor sleep, sleep 
hygiene lists are 
psychoeducational lists of recommendations designed to improve sleep. Addressing sleep 
hygiene entails an examination of sleep habits, behaviors, and environmental factors and 
helping individuals avoid issues that interfere with normal sleep patterns and engage in 
behaviors that promote good sleep. There is a range of recommendations. To consolidate the 
varying sleep hygiene lists used across the literature, the International Classification of Sleep 
Disorders diagnostic category for “Inadequate Sleep Hygiene” was used to guide the 
standardized sleep hygiene factors that will be discussed over the course of the intervention. In 
addition, we reviewed results of our Phase I qualitative research, Phase 2 pilot results, and the 
literature to create prototypes for a culturally-appropriate sleep hygiene presentation and 
handout. The discussion of these potential challenges for an individual’s sleep will occur over 
the course of two one-hour group sessions (week 1 and week 2) that are designed to be 
interactive. Sleep hygiene concepts will be discussed by a trained staff member (a sleep 
behavioral psychologist or a trained post-doctoral fellow), and participants will be encouraged to 
identify specific facets of sleep hygiene that they deem to be most problematic for their own 
sleep. The core components of SH, adapted as appropriate, will include regularization of wake 
times and avoiding naps in the evening, avoidance of substances that impair sleep, optimization 
of the sleep environment (temperature, noise), getting light during the day and doing adequate 
physical activity. At the end of the session, instructors lead participants through the completion 
of a daily sleep (& yoga) log. A handout will be provided to all participants following the group 
session, which will include a sleep (& yoga) log and an overview of all sleep hygiene concepts 
discussed. In the second SH session, the instructor will lead an informal group discussion 
prompting participants to share challenges, experiences, sleep and sleep hygiene goals. The 
instructor will encourage cross-talk among participants, facilitating ‘social support’. A research 
staff member will observe the group class and grade clarity in instruction. 
 
Following the group session, all participants will receive an individual phone call at week 4-5 
and weeks 8-9 from trained study staff to discuss their experiences with implementing 
behavioral and environmental changes to their sleep practices, as guided by the results of their 
own Sleep Hygiene Checklist. Building on individual strengths as well as by following principles 
of “choice architecture”, we will attempt to identify opportunities to change the home 
environment or solicit support from family members to make it easy for participants to “default” 
to the desired sleep habits (e.g., by moving electronics from the bedroom). Challenges to 
implementation will be discussed and addressed during this 10-15-minute phone conversation. 

Participants will be asked to continue to complete the paper logs for the duration of the 12-week 
intervention. 
 
Yoga Intervention (Y). After the two weeks of SH intervention, participants randomized to the 
SH+Y arm of the intervention will be invited to participate in one hour, once weekly, group 
sessions, for the subsequent 8 weeks. (Yoga classes will be offered at two different times per 
week, to provide flexibility in attendance.) A healthy snack (e.g., fruit) will be served after each 
yoga class). The main goal of the classes is to help increase participants’ skill and comfort with 
a set of yoga postures (see Yoga manual) and to help participants adopt a safe, daily/nightly 
yoga practice.  Each class will follow a similar format: check-in, active yoga poses, calming yoga 
poses, breathing and deep relaxation. Poses increase in difficulty with each subsequent 
segment. Instructors will encourage participants to practice daily at home on non-class days, 
with emphasis on nightly breathing exercises and relaxing and restorative postures. Participants 
will receive reinforcing materials such as yoga mat, yoga blankets and a handbook illustrating 
the protocol; this content will also be available via downloadable audio MP3 or YouTube video. 
To accommodate a range of physical abilities, teachers will use pre-specified variations of 
poses (e.g., chair based, using wall for support) as well as props (e.g., blankets). The nighttime 
breathing exercise will be observed by the teacher during each class to ensure participant 
fidelity.  Participants will be asked to record the amount of yoga they actually practice at home 
as well as sleep patterns using the daily logs (Table 1). Class instruction will be led or 
supervised by Dr. Jarvis Chen, an experienced yoga instructor. Additional trained instructors 
may work under his supervision as needed to accommodate the study schedule. A research 
staff member will observe each class and grade clarity in instruction and ability of participants to 
follow instructions and perform the maneuvers. 
 
We will audio record the SH group session and yoga sessions to serve as a resource for future 
staff leading these sessions in subsequent iterations of the study. The audio recordings will be 
stored on secure computers and will only be available for approved study staff to access. Only 
participant first names will be used in the group sessions, and therefore, on the recordings. 
Participants will be notified that they are being recorded for internal study purposes; participants 
will have the choice to veto the recording at any time and/or have the choice to be referred to by 
a fake name throughout the session, further reducing their identifiability. 
Study information (schedule) and resources (yoga handbook and audio recordings) will be 
available to access through a BWH website: http://yoga4sleep.brighamandwomens.org/. The 
image below is an example of a resource landing page. 

 
b. Drugs to be used  
N/A 
c. Devices to be used 
Participants will be instructed to use a wrist actigraph for 7 consecutive days and nights to 
measure sleep duration and sleep quality. The actigraph (GTX3+) is a triaxial device with a 
sampling rate of 100 Hz. It also has a light sensor that quantifies light spectra and intensity. The 
actigraphs can be worn continuously, even while bathing, and only need to be removed during 
prolonged period under water or with rigorous contact sports. Participants will be asked to 
complete a short actigraphy diary concurrently that can be completed in one minute or less that 
is used to help edit the actigraphy data.  
d. Procedures/ surgical interventions, etc.  
N/A 
e. Data to be collected and when the data is to be collected 

The study coordinator will be trained and certified in all study procedures and will administer 
surveys and make measurements following a standardized protocol.  
Measures: 
• 
*Height (calibrated stadiometer) 
• 
Weight (calibrated scale) 
• 
Blood pressure scale 
• 
Pulse 
• 
Actigraphy (1-week) + Actigraphy diary 
Assessments: 
1. *Demographics and Health History 
2. Sleep Hygiene Scale 
3. Intervention Feedback Scales (SH; yoga) 
4. *STOP Sleep Apnea assessment 
5. Women’s Insomnia Severity Rating Scale 
6. Dysfunctional Beliefs and Attitudes about Sleep-16  
7. Spielberg State-Trait Anxiety Inventory 
8. Physician Health Questionnaire-8 
9. Perceived Stress Scale 
10. PROMIS Sleep Disturbance Scale 
11. PROMIS Sleep Related Impairment questionnaire 
12. Sleep Self-Efficacy Scale 
13. Five Facet Mindfulness Questionnaire 
14. ***Exit interview form 
15. **Sleep (and yoga) log 
16. **Adverse Event Assessment 
*no 12-week follow-up 
**collected for the duration of the 12-week intervention 
***collected at follow-up only 
 
Baseline and Endpoint Measurements: A baseline and 12-week endpoint research visits will be 
scheduled at the community research site (RTH or MM). Data collection will include the 
following:    
• 
Blood pressure and heart rate: Participants will be asked to rest for 5 mins, and sitting 
blood pressure and heart rate will be measured (x3) using a calibrated automatic 
sphygmomanometer and be instructed on home actigraphy use.   
• 
Anthropometry measurements will be obtained using standardized procedures to 
measure:height (calibrated stadiometer) and weight (calibrated digital scale).   
• 
Questionnaires- Subjects will be administered a 45-70min survey battery, consisting of 
the following instruments:  
o Demographics and health history; Women’s Insomnia Severity Rating Scale; 
PROMIS Sleep Disturbance Scale; PROMIS sleep related impairment 
questionnaire 
o Dysfunctional Beliefs and Attitudes about Sleep-16; Sleep Hygiene Index; 
Spielberg State-Trait Anxiety Inventory; Physician Health Questionnaire-8; 
Perceived Stress Scale; Sleep Self-Efficacy Scale; Five Facet Mindfulness 

Questionnaire (FFMQ), short form (24 questions); yoga feedback scale (for 
SH+Y arm); sleep hygiene feedback scale (both arms)    
• 
Actigraphy and diaries: Participants will be instructed to use a wrist actigraphs for 7 
consecutive days and nights on their non-dominant wrist. An actigraphs is a battery 
powered device that can be worn continuously, even while bathing, and only need to be 
removed during prolonged period under water or with rigorous contact sports. It 
measures movement, from which sleep wake time is estimated. Participants will be 
asked to complete a short actigraphy diary concurrently that can be completed in one 
minute or less that is used to help edit the actigraphy data.  
• 
Sleep (and Yoga) Logs: Following the first SH education session, participants will 
complete a daily sleep monitoring log for the duration of the 12-week study. Participants 
randomized to yoga will receive a log that includes an additional prompt to log their daily 
yoga practice time and duration.  
 VI. Biostatistical Analysis 
a. Study endpoints and analytical approach 
• 
Reach of the target population: The number of potentially eligible individuals approached 
to participate will be tracked as well as the characteristics of individuals who do and do 
not choose to participate, and differences will be assessed. Reasons for choosing not to 
participate will be assessed using open ended questions (e.g., burden, perception of 
yoga, needs, etc.).  
• 
Adoption and adherence: We will assess the proportion of individuals that sustain 
participation throughout the intervention, and quantify attendance at classes and home-
practices through sleep (and yoga) logs and interim phone interviews. We will describe 
patterns of dropout rates and adherence to the interventions by key demographic factors 
and by moderating and mediating factors.   
• 
Implementation-consistency of delivery of the intervention: We will use a checklist of 
core intervention elements documenting the degree to which core elements of the 
intervention was delivered as specified in the protocol.   
• 
Missingness: We will describe the proportion of missing data. For measurements with 
more than 10% missingness, we will interview staff and participants to identify reasons 
(e.g., clarity, burden, etc.).  
• 
Data distributions: For each of the outcomes and candidate mediators, we will produce 
graphical displays and summary statistics such as means, medians, standard deviations, 
95% CIs, ranges, and proportions to describe the baseline, follow-up and change values 
and their distributions. Intervention groups will be compared using the Wilcoxon rank-
sum tests for continuous variables and Fisher's exact test for categorical variables. 
These analyses will provide us information on the variances for each measure and 
provide a range of effect sizes to use when developing the statistical plan for a later 
study.  
• 
Correlations and potential mediators: Spearman’s correlation coefficients will quantify 
the magnitude of association among mediators and moderators, and between changes 
in mediators and changes in study outcomes. This will help identify potential redundancy 
in measures (if similar constructs are highly correlated) and will identify variables 
strongly correlated with outcomes, which would be candidates for use in a later trial.   
• 
Dosing: We will plot self-reported sleep duration (from reports from objective and 
subjective assessments) to explore sleep duration vs time dose-response relationships 
(linear trends, thresholds, plateau in response). 

• 
Preliminary evidence for intervention effectiveness: Our primary outcome will be change 
in sleep duration measured by actigraphy (and diary) between baseline and 12 weeks. 
We will conduct a repeated measures ANCOVA, modeling time, intervention group and 
a time*intervention interaction. We will also explore change in stress, anxiety, depressive 
symptoms, mindfulness, and sleep hygiene score as potential explanatory variables. 
Secondary outcomes include change in systolic and diastolic blood pressure and resting 
pulse and PROMIS sleep impairment and sleep disturbances and insomnia score. 
 
d. Power analysis (sample size, evaluable subjects, etc.). The study is designed for feasibility 
and not powered to test the intervention effect. The SH+Y intervention will be considered as 
potentially efficacious if the estimates for the change scores (post-pre within and between group 
changes and their 95% CIs) are consistent with clinically significant improvements in sleep 
duration (actigraphy sleep increases by > 30 minutes), sleep quality improves by > 0.5 SD), or 
sleep hygiene (reduction in deviation in wake time relative to recommended wake time > 25%). 
We will consider inclusion of specific measurements (mediators) in a future RCT based on: 
<10% missingness; correlation of change score or baseline score with outcomes of >.20; 
absence of redundancy with a simpler metric (r<.80).  
 
VII. Risks and Discomforts (stratify by common and uncommon) 
Device complications/malfunctions. The actigraphy is battery powered with minimal risk. The 
main risk may be irritation under the band. This will be minimized by asking participants to 
remove the band and dry skin if the band gets wet. 
A. COMMON/ POSSIBLE LIKELIHOOD 
 
Discomfort in answering questions.  
This study involves the completion of self- or interviewer-assisted written surveys, and it is 
possible that some people may feel uncomfortable answering some of the questions or asking 
the survey administrator for assistance in completing the questionnaire.  
 
Minimization of risk: Surveys will be conducted by a trained member of the study staff. Those 
that are orally administered will occur in a private room or partitioned area.  All participants can 
withdraw from the study. Participants will be informed that they may discontinue the survey at 
any time for any reason, and that they can skip any questions that they feel uncomfortable 
answering with no penalty to current or future health care. We have also selected validated 
instruments that have been widely used, and thus we anticipate the concern, while possible, will 
be minimized. We do not anticipate that any questions will be so upsetting to participants that 
extra support will be required. However, we will develop a referral sheet for additional resources 
in the unlikely event that this should occur. 
  
Discomfort or bruising on the arm with blood pressure measurements 
It is possible that inflation of the blood pressure cuff, may causes mild discomfort. This 
discomfort generally disappears within minutes of the cuff being released.  
 
Minimization of risk:  All cuffs will fit for each participant, selecting the most appropriate size. 
Participants will be instructed by trained study staff on how to remove/deflate the cuff should 
pain occur or should the cuff not deflate.  
 
Sleep disruption associated with actigraphy  

It is possible that by wearing special monitoring devices, participants may feel that their sleep is 
not as good as is typical.  
 
Minimization of risk: Devices have been chosen that are as minimally intrusive as possible. 
Participants will be provided clear instructions by trained study staff on how to use these 
devices to minimize discomfort.  They will be instructed how to remove and replace the devices 
if needed, or can discontinue the monitoring is necessary.  
   
Yoga related Muscle strain/sprains/injury.  
It is possible that yoga can cause muscle strain or sprain, including ankle injuries and back 
injury, with resultant pain and limitation of movement. Rarely, there may be nerve damage or 
risk of certain types of stroke. 
 
Minimization of risk: Yoga will be taught by experienced instructors who are familiar with proper 
technique, contraindications, and ways to minimize injury. Class size will be small to allow for 
close interaction between the participant and instructor, and ensure use of correct postures to 
minimize injury. Injury also will be minimized by performing yoga in defined sequences and 
gradually increasing challenges. Participants will be excluded if recent (within 3 months) major 
surgery or head injury, glaucoma, history of significant vertebral injuries. Although participants 
who are known to be pregnant will be excluded, we will choose poses that are safe in 
pregnancy.  Participants will be asked to refrain from eating before yoga classes. In the 
beginning of each class, participants will be encouraged to take stock of their current physical 
condition and check with the yoga instructor if experiencing pain before or during yoga. The 
instructor will make accommodations (such as use of yoga straps or blocks) to address 
individual needs.  
 
Undiagnosed/untreated depression, insomnia or sleep apnea.  
 
1. Minimization of risk: If any participant reports suicidal ideation or has a PHQ-8 score 
> 19, the coordinator will page the PI or her designee and determine immediacy for 
referral, including, as appropriate, making arrangements to emergency room 
evaluation, timely clinic follow-up, or a new medical referral. If a Women’s Insomnia 
Severity Rating Scale score is found to be >10 or a report of untreated sleep apnea 
is identified, the participant will be provided information on local sleep center 
resources, and the staff will offer to provide the participant’s physician relevant 
information and/or directly facilitate specialty referral.  If a blood pressure is 
measured to be > 180/110, the coordinator will communicate this to the PI or her 
designee within 24 hours and determine appropriateness for further action, including 
communicating with the participant’s primary physician or making a new medical 
referral. 
 
B. UNCOMMON/ RARE LIKELIHOOD 
 
Loss of confidentiality.  
It is possible that identifiable information may be inadvertently disclosed outside of the research 
arena through oral or written channels.   
 
Minimization of risk: Confidentiality will be maintained by numerically coding data and by 
disguising identifying information. All information obtained from survey respondents and 
interviewees will be accessible only by authorized research staff.  Special precautions will be 

implemented to ensure the confidentiality of patient responses. We will assign all respondents a 
unique identification number. No individual names or housing site names will be used on the 
survey. The cross-list matching names and codes will be kept in locked file drawers and will only 
be accessible to study staff on password-protected computers. All data collected electronically will 
use encrypted methods that include secure methods of data transfer. We will ensure that any 
information shared with collaborators will have all identifiers removed to protect the 
confidentiality of respondents; only IDs will be used and the minimal amount of information 
needed will be shared.   
 
 
VIII. Potential Benefits 
The potential benefits and importance of the knowledge gained through this study are significant 
for both participants and for the scientific community, and outweigh the minimal risks posed to 
participants.  Sleep related disparities are significant among low income and under-represented 
populations, and understanding the feasibility of potentially successful interventions to improve 
sleep outcomes offers the significant potential to identify levers for reducing these disparities. 
Participants will also receive feedback on their sleep patterns which will be helpful to them in 
managing their own health. With their permission, this information will be shared with their health 
care providers. Participants also may directly benefit from participation in the sleep hygiene and 
yoga interventions, with improved stress and sleep. 
 
IX. Monitoring and quality assurance 
Data safety and monitoring. The data from this project will be monitored by the study’s Data and 
Safety and Monitoring Board (DSMB) which has been assembled and includes three external 
researchers with expertise in sleep medicine, yoga, clinical trials, and disparities research. The 
DSMB has already approved the Phase I and Phase 2 of study and tentatively approved this Year 
3 RCT protocol. In Year 3, they will meet to review recruitment and retention, data integrity and 
adverse events. The DSMB Chair will also receive any reports of serious or unexpected adverse 
events in real time.    
The DSMB will review the work and adverse event at mid-way point/ 6 weeks after intervention 
start and then again after the study concludes at 12 weeks.  
A Data Safety Monitoring Plan will specify how to handle abnormal findings (blood pressure, 
depression), including physician evaluation and notification of participant and their physician, 
making arrangements for acute treatment, as appropriate. For example, significant 
abnormalities will be communicated by a physician by phone within 24 to 48 hours of 
identification (depending on severity). For individuals who endorse suicidal ideation, a physician 
will evaluate the individual and recommend appropriate action (e.g., referral to a known 
physician, emergency room referral).   
 
Reporting of Serious Adverse Events (SAEs). The project director will be responsible for 
reporting SAEs to the NIH and BWH’s IRB within 24 hours of first knowledge of the event via 
telephone, followed by completion of the corresponding case report form within 48 hours.  
Within the following 48 hours, the investigator will provide further information on the SAE in the 
form of a written narrative.  This will include a copy of the completed SAE form, and any other 
diagnostic information that will assist the understanding of the event.  Copies of all 
correspondence with the IRB will be maintained in the study regulatory binder.  

 
On an ongoing basis, Dr. Redline will review the results of summary data to identify any values 
of concern.   
 
Components of our Data Security Monitoring Plan: (1) secure/maintain IRB approval; (2) ensure 
that study staff and others with direct contact with participants and/or access to their identifiable 
data complete NIH human research certification, CITI, and other human research training 
programs, as required; (3) include human subjects’ concerns as a standard agenda item for 
regular project meetings.  
 
Research Material. Surveys and logs will be obtained from living human subjects, specifically 
for research purposes.  Research data will be kept in a locked file cabinet or saved in password-
protected computer files behind Partners firewall.  Research data collection forms for all 
research information will be coded and will not contain information on participants.  A master 
list, linking participant identifiers with the study code, will be kept separately from other research 
data and in a secure location, accessible only to study staff.   
 
Participant Refusal. A record will be kept of the number of participants who are approached, 
but refuse to participate in the study. For tracking purposes, the reason for refusal, when 
obtained, will be documented.  
 
Compensation. Participants randomized to the SH-only arm will receive $25 for the 
consent-baseline visit and up to $50 more for the subsequently completed visits ($10/each) 
to be distributed week12 at the endpoint visit, for a total of $75 in gift cards to Stop&Shop. 
Participants randomized to the SH+Y arm will receive $25 for the consent-baseline visit and 
up to $110 more for the subsequently completed visits ($10/each) to be distributed week12 
at the endpoint visit, for a total of $135 in gift cards to Stop&Shop. Participants will also 
receive a yoga mat, 3 yoga blankets and a yoga strap. A healthy snack will be offered after 
all the yoga classes.  
In addition, a light dinner will be served at the SH1 and SH2 visits. To mitigate barriers to 
attending in-person visits, participants with young children will be offered complimentary 
childcare available through RTH. Additionally, when study sessions occur during dinner time, we 
will provide the children with a light dinner (e.g., pizza) at all group sessions.  
 
Institutional Review Board. It is the responsibility of the Principal Investigator to provide the 
IRB with all pertinent material, including a copy of the informed consent given to participants.  
Approval of the protocol and the verbal informed consent form must be obtained prior to enrolling 
any participants in the study.  The Principal Investigator also maintains the responsibility of 
initiating protocol re-approval, notification of protocol and/or consent form changes according to 
the appropriate IRB requirements.   
 
Record Keeping. Participant study documents must be made available when necessary for 
safety and quality control and/or as required by law for regulatory purposes.  These documents 
should be organized in binders or files (outlined below) and stored in accordance to security and 
record retention regulations and until further written notice by the NIH. All information obtained 
will be kept in locked files and password-protected computers. Audiotapes of any sessions will 
be kept for six years. 
 
 

 
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