Effect of Long Term Sleep Restriction on Energy Balance
Phase: NA
Conditions: Sleep, Obesity, Sleep Restriction
Sponsor: Columbia University

Title: Effect of long term sleep restriction on energy balance
NCT number: NCT02960776
Date: 03/28/2024

 
 
  
Is the purpose of this submission to obtain a "Not Human Subjects Research" determination?
No
 
 
8. Continuing review of research previously approved by the convened IRB as follows:  (a) where (i) the
research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all
research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects;
or  (b) where no subjects have been enrolled and no additional risks have been identified; or  (c) where the
remaining research activities are limited to data analysis.
 
 
Enrollment status:
Closed to further enrollment: remaining research activities are limited to data analysis only
Provide any additional information necessary to explain the study status:
No participant was enrolled or accrued in the last period and none are planned in the upcoming renewal period. This
study is only open for data analyses and reporting.
Since the last renewal:
Have there been any changes in the relevant literature that would affect the study design or procedures?
No
Have there been any interim findings associated with this study?
Yes
Please Describe:
We have published data on lipid profile and inflammatory markers. Paper in press on cognitive function.
Have there been any publications resulting from this study?
Yes
Please Describe:
Barragán R, Zuraikat FM, Cheng B, Scaccia SE, Cochran J, Aggarwal B, Jelic S, St-Onge M-P. Paradoxical effects
of prolonged insufficient sleep on lipid profile: A randomized trial. JAHA 2023 Oct 10:e032078D. PMID:37815115.
Zimmerman ME, Benasi G, Hale C, Yeung LK, Cochran, Brickman AM, St-Onge M-P. The effects of insufficient
sleep and adequate sleep on cognitive function in healthy adults. Sleep Health, in press.
Columbia University Human Subjects Protocol Data Sheet
General Information
Protocol:
AAAQ7746(M00Y09)
Protocol Status:
Approved
Effective Date:
02/05/2024
Expiration Date:
02/04/2025
Originating Department Code:
MED Obesity (752060X)
Principal Investigator:
St Onge, Marie Pierre (ms2554)
From what Columbia campus does this research
originate:
Medical Center
Title:
Impact of sleep restriction on performance in adults
Protocol Version #:
Y1M1-Adm Suppl
Abbreviated Title:
NIH Sleep Restriction
Was this protocol previously assigned a number by an IRB:
No
IRB Expedited Determination
Renewal Information
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Have any participants been enrolled using the Short Form process?
No
Is there a Data Monitoring Committee (DMC), Data Safety Monitoring Board (DSMB), or other monitoring entity for
this study?
No
Is an annual Progress Report required by the funding organization or coordinating center for this study?
No
Does this submission include a modification?
Yes
Provide a description of, and explanation for, all changes being proposed in this submission:
Personnel not involved in data analyses or reporting have been removed.
Indicate which sections of the Rascal submission are affected by the proposed modification. Each marked
section must be revised as part of this submission:
Has the Investigator’s Brochure (IB) or Device Manual been revised in this submission?
No
Has the consent form been revised in this submission?
No
Does this submission include a report of a protocol violation?
No
 
 
Special review type: Check all that apply or check "None of the Above" box.
[  ]Review for 45 CFR 46.118 Determination (involvement of human subjects is anticipated but is not yet defined)
[  ]Funding review for Administrative IRB approval (such as for Center or Training Grants)
[x]None of the above
  
IRB of record information: Will a Columbia IRB be the IRB that is responsible for providing review, approval, and
oversight for this study?
Yes
Select the most appropriate response:
Columbia will be the IRB of record for the study procedures conducted by Columbia researchers (Note: this
response will apply to most submissions).
  
Is this research part of a multicenter study?
No
  
Please indicate if any of the following University resources are utilized:
[  ]  Cancer Center Clinical Protocol Data Management Compliance Core (CPDM)
[  ]General Information
[  ]Procedures
[  ]Attributes
[  ]Recruitment/Informed Consent
[  ]Background
[  ]Research Aims and Abstracts
[  ]Exempt and Expedited
[  ]Risks/Benefits/Monitoring
[  ]Funding
[  ]Subjects
[  ]Locations
[  ]Attachments (including Rascal-generated attachments)
[x]Personnel
[  ]No revisions to submission content required
[  ]Privacy and Data Security
Attributes
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[x]  CTSA-Irving Institute Clinical Research Resource (CRR)
[  ]  CTSA- Irving Institute Columbia Community Partnership for Health (CCPH)
[  ]  None of the above
 
 
Abbreviated Submission:
The IRB has an abbreviated submission process for multicenter studies supported by industry or NIH
cooperative groups (e.g., ACTG, HVTN, NCI oncology group studies, etc.), and other studies that have a complete
stand-alone protocol. The process requires completion of all Rascal fields that provide information regarding
local implementation of the study. However, entering study information into all of the relevant Rascal fields is not
required, as the Columbia IRBs will rely on the attached stand-alone (e.g., sponsor's) protocol for review of the
overall objectives.
If you select the Abbreviated Submission checkbox and a section is not covered by the attached stand-alone
protocol, you will need to go back and provide this information in your submission. 
  
Study Purpose and Rationale:
Provide pertinent background description with references that are related to the need to conduct this study. If
this is a clinical trial, the background should include both preclinical and clinical data. Be brief and to the point.
[  ]  Abbreviated Submission - This information is included in an attached stand-alone protocol. Proceed to the next
question
Background
Chronic Sleep Restriction (SR) is highly prevalent in today’s modern society [1]. Artificial light, portable
electronic devices, and 24-h services have allowed individuals to remain active throughout the night,
leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been
interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the
increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep
duration [2], further exploration into the role of sleep as a risk factor for obesity could provide additional
ammunition in the fight to prevent further increases in the incidence of obesity. Currently, the prevalence of
obesity is approximately 33% in 20-39 y-olds and 37% in 40-59 y-olds [3]. It is well known that obesity is
associated with an increased risk of type 2 diabetes and cardiovascular disease (CVD), along with other
debilitating diseases including orthopedic problems, cancer, and dementia. Those associated disorders are
accompanied by high healthcare costs, as well as reduced productivity [4]. Furthermore, our target
population (adults age 20-40 y) is within the adult age range with the lowest prevalence of obesity,
precedes the age range with highest prevalence of obesity [3], and is the one with the most striking
association between SSD and obesity [5,6]. Our current state of knowledge surrounding the relationship
between SSD and obesity stems largely from cross-sectional studies: short sleepers have a higher BMI
than normal sleepers and have higher odds of obesity [7, 8]. Longitudinal studies also point to an increased
risk of large weight gain over time in short sleepers relative to normal sleepers [9-11]. However, those
studies cannot infer causality and are fraught with limitations such as self-report of sleep duration, which
could lead to bias. Only two longitudinal studies have objectively measured sleep duration with actigraphy,
and those have not found any association between SSD and weight gain over time [12, 13]. Of note is that
one of those studies was performed on women who were 48-59 y old at baseline [12], an age range in
which sleep duration is less closely related to obesity risk. In the proposed study, the target population will
be <40 y, an age group identified as being at highest risk of large weight gain with sustained short sleep
[14]. Given the cross-sectional evidence of an association between SSD and obesity, from both
questionnaire and actigraphy assessments of sleep, investigation of possible causal relationships is
warranted. Capers and colleagues recently published a meta-analysis concluding that no studies exist to
assess the effects of long-term manipulation of sleep duration on obesity risk [15]. They further “call for
additional research using more standardized methods and measures, as well as evaluations of associated
outcomes with sufficient sample sizes and duration to ascertain whether a causal relationship truly exists
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between sleep duration and body weight regulation”. This will be fulfilled should the proposed study be
funded. Clinical intervention studies, on the other hand, have consistently shown that SR increases EI in
normal sleepers [16-19] above and beyond the added cost of waking EE [20]. Criticisms of these studies
are that they have employed short intervention periods, ranging from a single night to 14 d, and have tested
very restrictive sleep schedules, typically 3 h less than Habitual Sleep (HS) (4-5.5 h TIB). Although these
studies provide information on causality, many questions remain unanswered: Does longer, milder SR as
observed in individuals with SSD, lead to positive energy balance (Aims 1 & 2)? Is the increased EI
observed in acute studies maintained over time and if so, does it result in increased adiposity (Aim 1) and
adverse cardiometabolic risk profile (Aim 3)? The proposed study will answer these critical questions. 
In addition to being a risk factor for cardiovascular disease, type 2 diabetes, and obesity [21], short sleep
duration (SSD) is related to an increased risk of cognitive impairment in older adults [22,23]. Individuals at
lowest risk of cognitive impairment are those with adequate sleep duration of 7-8 h/night [22]. SSD may
induce cognitive impairment in older adults by promoting Alzheimer’s disease pathology directly. Indeed
recent studies showed that inadequate sleep is associated with Alzheimer’s disease biological markers,
including cerebrospinal fluid measures of beta amyloid and measures of fibrillar amyloid derived from
positron emission tomography (PET) [24]. Intervention studies demonstrated increased circulating plasma
levels of amyloid beta in young adults [25] and increased fibrillar brain amyloid beta in older
adults [26] following one night of sleep deprivation. However, there are no studies to date that have
evaluated the impact of long-term, sustained short sleep duration, mimicking the widespread sleep behavior
of U.S adults, on cognitive function in older adults, and the mediators and moderators of the effect of sleep
deprivation on cognitive outcomes are poorly understood. The proposed supplementary study examines the
effect of sleep restriction on cognitive outcomes in older adults and tests the possibility that cerebral
atrophy, cerebrovascular disease, and hormonal markers mediate this effect.   
The currently-funded Sleep Restriction Study (R01 HL128226, PI: St-Onge) provides an ideal opportunity to
measure changes in cognition in cognitively normal young and older adults undergoing SR. The protocol
enrolls young adults, normally sleeping 7-9 h/night, into a randomized controlled trial of 2 intervention
periods of 6 wk each, differing in the length of the sleep episode: either habitual sleep (HS) or habitual sleep
minus 1.5 h (SR). The main objective of the parent study is to evaluate the impact of SR on energy balance
regulation and explore a mechanism via alterations in hormonal and metabolic markers. The proposed
supplement seeks to incorporate a neuropsychological evaluation to the current application; recruit a group
of older adults (age range 55-75 y) with normal sleep function; and collect magnetic resonance imaging
(MRI)-derived measures of brain atrophy (volumetry and cortical thickness in Alzheimer’s disease -related
regions) and cerebrovascular disease (white matter hyperintensities) into the ongoing crossover study. In
this project, we will assess whether SR challenges acute cognitive outcomes in older and younger adults
(Aim 4), whether these effects are moderated by brain atrophy and small vessel cerebrovascular disease
(Aim 5), and if changes in metabolic or hormonal profiles mediate changes in cognitive function as a result
of SR (Aim 6).
References:
Luckhaupt, S.E., S. Tak, and G.M. Calvert, The prevalence of short sleep duration by industry and
occupation in the National Health Interview Survey. Sleep. 33(2): p. 149-59.
1.
Keith, S.W., et al., Putative contributors to the secular increase in obesity: exploring the roads less
traveled. Int J Obes (Lond), 2006. 30(11): p. 1585-94.   
2.
Flegal, K.M., et al., Prevalence of obesity and trends in the distribution of body mass index among US
adults, 1999-2010. Jama, 2012. 307(5): p. 491-7.
3.
Andreyeva, T., J. Luedicke, and Y.C. Wang, State-level estimates of obesity-attributable costs of
absenteeism. J Occup Environ Med, 2014. 56(11): p. 1120-7.
4.
Gangwisch, J.E., et al., Inadequate sleep as a risk factor for obesity: analyses of the NHANESI.
Sleep, 2005. 28(10): p. 1289-96.
5.
Magee, L. and L. Hale, Longitudinal associations between sleep duration and subsequent weight
gain: a systematic review. Sleep Med Rev, 2012. 16(3): p. 231-41.
6.
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Cappuccio, F.P., et al., Meta-analysis of short sleep duration and obesity in children and adults.
Sleep, 2008. 31(5): p. 619-26.
7.
Chen, X., M.A. Beydoun, and Y. Wang, Is sleep duration associated with childhood obesity? A
systematic review and meta-analysis. Obesity (Silver Spring), 2008. 16(2): p. 265-74.
8.
Patel, S.R., et al., Association between reduced sleep and weight gain in women. Am J Epidemiol,
2006. 164(10): p. 947-54.
9.
Chaput, J.P., et al., The association between sleep duration and weight gain in adults: a 6-year
prospective study from the Quebec Family Study. Sleep, 2008. 31(4): p. 517-23.
10.
Lopez-Garcia, E., et al., Sleep duration, general and abdominal obesity, and weight change among
the older adult population of Spain. Am J Clin Nutr, 2008. 87(2): p. 310-6.
11.
Appelhans, B.M., et al., Sleep duration and weight change in midlife women: the SWAN sleep study.
Obesity (Silver Spring), 2013. 21(1): p. 77-84.
12.
Lauderdale, D.S., et al., Cross-sectional and longitudinal associations between objectively measured
sleep duration and body mass index: the CARDIA Sleep Study. Am J Epidemiol, 2009. 170(7): p.
805-13.
13.
Theorell-Haglow, J., et al., Both habitual short sleepers and long sleepers are at greater risk of
obesity: a population-based 10-year follow-up in women. Sleep Medicine, 2014. 15(10): p.1204-
1211.
14.
Capers, P.L., et al., A systemic review and meta-analysis of randomized controlled trials of the
impact of sleep duration on adiposity and components of energy balance. Obes Rev, 2015.16(9): p.
771-82.
15.
Brondel, L., et al., Acute partial sleep deprivation increases food intake in healthy men. Am J Clin
Nutr, 2010. 91(6): p. 1550-9.
16.
Nedeltcheva, A.V., et al., Sleep curtailment is accompanied by increased intake of calories from
snacks. Am J Clin Nutr, 2009. 89(1): p. 126-33.
17.
Bosy-Westphal, A., et al., Influence of partial sleep deprivation on energy balance and insulin
sensitivity in healthy women. Obes Facts, 2008. 1(5): p. 266-73.
18.
St-Onge, M.-P., et al., Short sleep duration increases energy intakes but does not change
expenditure in normal weight individuals. Am J Clin Nutr, 2011. 94(2): p. 410-416.
19.
Shechter, A., et al., Experimental sleep curtailment causes wake-dependent increases in 24-h
energy expenditure as measured by whole-room indirect calorimetry. Am J Clin Nutr, 2013.     
20.
St-Onge, M.P., et al., Sleep Duration and Quality: Impact on Lifestyle Behaviors and
Cardiometabolic Health: A Scientific Statement From the American Heart Association.Circulation,
2016. 134(18): p. e367-e386.
21.
Wu, L., D. Sun, and Y. Tan, A systematic review and dose-response meta-analysis of sleep duration
and the occurrence of cognitive disorders.Sleep Breath, 2017.
22.
Kronholm, E., et al., Self-reported sleep duration and cognitive functioning in the general
population.J Sleep Res, 2009. 18(4): p. 436-46.
23.
Spira, A.P., et al., Impact of sleep on the risk of cognitive decline and dementia.Curr Opin
Psychiatry, 2014. 27(6): p. 478-83.
24.
Wei, M., et al., Sleep Deprivation Induced Plasma Amyloid-beta Transport Disturbance in Healthy
Young Adults.J Alzheimers Dis, 2017. 57(3): p. 899-906.
25.
Shokri-Kojori, E., et al., beta-Amyloid accumulation in the human brain after one night of sleep
deprivation.Proc Natl Acad Sci U S A, 2018. 115(17): p. 4483-4488. 
26.
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Study Design:
Describe the methodology that will be used in this study, covering such factors as retrospective vs. prospective
data collection, interventional vs. non-interventional, randomized vs. non-randomized, observational,
experimental, ethnography, etc.
[  ]  Abbreviated Submission - This information is included in an attached stand-alone protocol. Proceed to the next
question
We propose a randomized, crossover, outpatient sleep restriction study with 2 phases of 6 wk
each. Sixty -six men and pre-menopausal women, age 20-40 y, BMI 20-34.9 kg/m2, who have at
least one parent with BMI >27 kg/m2 (if participant BMI is 20-24.9 kg/m2), will be recruited from
the New York City area. Participants who will be recruited to participate in this study will habitually
sleep 7-9 h/night, will be free of any current and past sleep and psychiatric disorders, including
eating disorders, and will not have diabetes or CVD.  The sleep durations will be the participant’s
regular bed- and wake-times during the habitual sleep (HS) phase and HS minus 1.5 h in the sleep
restriction (SR) phase. During the HS phase, participants will be asked to follow a fixed bedtime
routine based on their screening sleep schedule. During the SR phase, participants will be asked
to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 h in
total sleep time. Two weeks prior to randomization and during washout periods, participants will
wear an actigraph (Micro Motion Logger Sleep Watch, Ambulatory Monitoring, Inc., Ardsley, NY)
and keep a sleep diary to verify sleep duration and sleep-wake schedule. In addition to achieving
an average sleep of 7-9 h/night, per wrist actigraphy, participants will only be enrolled if they
achieve 7 h of sleep for at least 10 of the 14 nights of screening and have <4 nights with <6 h of
sleep. At randomization, a urine pregnancy test (for women) and drug screen will be performed.
Participants will be asked to abstain from caffeine and alcohol intake for 24 h prior to the start of
each study phase. Between study phases, if participants have not returned to baseline sleep
patterns, an additional 2-4 wk washout period will be provided. In general, washout periods will be
6 wk in duration. This washout length enhances the likelihood that women will be in the same
phase of their menstrual cycle at the start of each experimental phase. On the first day of each
study phase (baseline), participants will come to Irving Center for Clinical and Translational
Research (CTSA) at Columbia University in the morning after an overnight, 12-h fast. Participants
will have anthropometric measurements taken, will provide a fasting blood sample, and will then be
taken to the department of Radiology to undergo MRI scanning to assess body composition.
Participants will begin the fixed bedtime routine that night. These baseline measurements will be
repeated at endpoint, 6 wk later. Body weight and waist circumference will be measured weekly,
fasting blood and urine samples will be taken at baseline, week-3, and endpoint, during adherence
check visits.  Brain responses will be assessed using two fMRI paradigms (resting state and task-
based) at wk 6, 1 h before the participant’s self-reported usual dinner time. The resting state
paradigm and intrinsic functional connectivity (iFC) analysis will assess treatment effects on reward
and interoception-related neuronal circuitry.  During the resting state scan (2 runs, each ~ 5 mins),
participants will focus on the fixation cross in the center of the screen. Wakefulness and
compliance with eyes-open instructions will be monitored via an eye-tracking camera and verbal
reminders given before every run. Pulse and respiration rates will be measured using MRI-
compatible non-invasive physiological monitoring equipment.  Food intake will be assessed at
baseline, wk 3, and wk 6 by 3-d food records (2 weekdays and one weekend day) using an
electronic app or by hand if the participant does not have a smart phone. EE will be assessed
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using DLW, as previously done in our Sleep Study [8], during the last 2 wk of each sleep phase. At
the 4-wk compliance check, participants will be asked to provide fasting blood, urine and saliva
samples prior to taking a dose of DLW (2.5 g 18O, 10% atom percentage excess [APE] and 0.12 g
2H2O 99.9% APE per kg estimated body water). This will be followed by a 50 mL water rinse.
Participants will be asked to minimize food and beverage consumption over the following 4 h and
to collect saliva samples at 3 and 4 h post-dosage. Participants will be given vials to collect these
samples as well as cups to collect second void urine samples at 24 h, 7 d, and 14 d post-dosing.
Participants will be asked to freeze their samples at home and bring them to the research center at
the next compliance check visit. Isotope measurements will be made by Off-Axis Integrated Cavity
Output Spectroscopy in the laboratory of Dr. Edward Melanson at the University of Colorado.  
Older participants enrolled in this study will undergo the same procedures as the younger participants
enrolled in the parent study except for two assessments: (1) functional neuroimaging of brain responses to
food stimuli and resting-state neuroimaging; (2) doubly-labeled water dosing for measurements of free-living
energy expenditure. These measurements cannot be performed due to budgetary constraints and given the
focus on cognitive function for this supplement. However, all other assessments, including measurements
of body composition by MRI, hormone and metabolite assessments, and measurements of food intake and
physical activity level, will be performed. In addition, participants in the parent cohort who will be enrolled in
this study during the time of this award will undergo additional assessments related to cognitive function
and imaging as detailed below. A structural brain MRI acquisition protocol to measure cortical thickness,
regional volumes, and markers of cerebrovascular disease will be included for both younger and older
participants.  
 
Participants will perform tests included in the NIH Toolbox at baseline and week 6 of each study phase. The
test battery will be performed in the morning, after an overnight fast, in conjunction with blood
sampling.These computerized tests will be supplemented with the ModRey. For this test, participants are
read a series of words and asked to recall them during three learning trials, after a brief delay, and after a
longer delay. There is also a distractor list and a memory recognition trial. The learning and short delay
trials will be administered prior to administration of the NIH Toolbox and the long delay and recognition trials
will be administered afterwards. Psychometrically similar alternative forms are available and will be
counterbalanced. 
  
  
Statistical Procedures:
Provide sufficient details so that the adequacy of the statistical procedures can be evaluated including power
calculations to justify the number of participants to be enrolled into the study. Definitions of subject terms such
Structural brain imaging will be performed at Columbia University Irving Medical Center. This procedure
will take place in conjunction with the whole-body scan that is currently performed in the parent
study and will only be performed at baseline of phase 1. The protocol derives measures of brain
atrophy/volumetry and white matter hyperintensities, but we will also examine microbleeds and
infarcts for secondary analyses. Scanning will take place in a single session and include a high-
resolution T1-weighted anatomical scan (MPRAGE), T2-weighted FLAIR, and gradient echo
(GRE). We will also collect diffusion-weighted imaging and diffusion tensor imaging data for
secondary or exploratory analyses. The MRI data will be transferred to a PACS for clinical review
and via established, secure DICOM servers the data are also transferred to Dr. Brickman’s
laboratory for analysis.
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as enrolled and accrued as used for Rascal submissions can be found in the Subjects section.
[  ]  Abbreviated Submission - This information is included in an attached stand-alone protocol. Proceed to the next
question
Sample size determination. We will enroll 66 participants and expect 50 to complete the study. This drop-
out rate accounts for participant non-compliance. In our previous Sleep Study, our completion rate was
90%.  We expect a larger drop-out rate in the proposed study due to the longer duration of each treatment
phase, and we also anticipate dismissing some participants due to non-compliance.  Each participant will
undergo 2 study phases, and each response variable will be measured at least once per phase. Thus, for
each response measure we will have at least 50 x 2 paired observations.  We have analyzed preliminary
data consisting of a number of measurements from 2 overweight women from our Pilot Study. Based on
preliminary data analysis we have estimated an effect size (mean paired difference) of 0.69 ± 0.36 g for fat
mass and an effect size (mean paired difference) of 0.91 ± 0.65 g for weight gain. This translates to very
large effect sizes of 1.92 (fat mass) and 1.4 (weight gain) for paired t-tests.  With these effect sizes we have
more than 99% power for paired t-tests.] We have estimated the EI effect size to be 295.9 ± 116.3 kcal [8].
The effect size for a paired t-test (effect size divided by the standard deviation) for a paired t-test is >2,
which is a very large effect size for paired t-test. This means with 50 x 2 paired samples, we have >80%
power for paired t-test. In St-Onge et al. 2011 [8], we also reported an effect size of 20.7 ± 6.8g for fat
intake and an effect size of 57.9 ± 32.6 g for carbohydrate intake. This translates to very large effect sizes
of 3.04 and 1.78, respectively for fat and carbohydrates for paired t-test. With these effect sizes we have
>80% power for paired t-test. Moreover, using the R2 value from our linear model analysis of St-Onge et
al.2011, we determined that we have>80% power for proposed linear mixed model analyses (as described
in statistical plan) with energy balance, fat and carbohydrate intakes. Thus, we have very good power
overall, which will be useful in our primary analyses as well as in exploring sex differences. Statistical plan.
Exploratory data analyses for physiological, anatomical, biomarker and intakerelated responses will be
performed using R, SAS and other software. As part of the analysis, we will compute descriptive statistics
for each variable. In particular, we will compute the proportion, mean, variance, standard error and the
range of continuous variables and frequency and mode for discrete variables. Descriptive statistics will be
computed for each specific sleep phase. In addition, correlation coefficients between the variables will be
computed and scatter plots will be checked for linear relationships. The correlations and scatter plots help
assess the degree of collinearity among variables, which will be useful for interpreting regression-based
linear mixed model analyses discussed later. The data will be tested for normality, and if needed an
appropriate transformation will be used on the raw data to make the normal approximation better. We will
have a comprehensive strategy to deal with missing data. We will study missingness to decide if the data
are missing at random or missing completely at random. Missing rates will also be estimated for each
variable. Missing values will be imputed, as appropriate.  We will fit a linear mixed model to analyze the
data. Treatments (sleep duration: SR vs. HS) will be fixed effects and subjects a random effect. As we are
collecting data from two phases for each subject, we will test for carryover effects by using a treatment x
phase interaction in an initial version of each linear model. If the interaction term is not significant then we
will rebuild the linear model without the interaction term. The other independent variables (covariates) will
be sex, age, baseline BMI, and race/ethnicity. If required anywhere in the analysis plan, p-values will be
adjusted for multiple comparisons. Sp. Aim 1: Hypothesis 1a. SR will lead to increased total adipose tissue
mass, as assessed using MRI, relative to HS. We will perform repeated measure linear mixed model
analyses separately for adipose tissue mass increase and weight gain (as the response). Sleep duration
(SR vs. HS) and the covariates will be used as independent variables. Subject will be used as a random
effect. Paired t-test and Wilcoxon test will be used to determine whether the SR and HS have different
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effects on weight gain and adipose tissue mass increase.Hypothesis 1b. EE, assessed by DLW, and
physical activity level, monitored daily by actigraphy, will be lower during SR relative to HS. We will perform
repeated measure linear mixed model analyses separately for DLW and actigraphy-derived variables as the
responses. Sleep duration (SR vs. HS) and the covariates will be used as independent variables. Subject
will be used as a random effect. Paired t-test and Wilcoxon test will be used to determine whether SR and
HS have different effects on DLW and actigraphy measures.Sp. Aim 2: Hypothesis 2a. EI, assessed by [3-d
food records], will be greater during a period of SR relative to HS. This will be mostly due to increased fat
and carbohydrate intakes. We will perform a repeated measure linear mixed model analyses separately
with each EI measure (as the response) and sleep duration (SR vs. HS) and the covariates as independent
variables. Subject will be used as a random effect. Paired t-test and Wilcoxon test will be used to determine
whether the SR and HS have different effects on EI measures.Hypothesis 2b. Neural responses to food
stimuli, assessed by fMRI after 6 wk of SR or HS, will indicate increased activity in networks associated with
reward and food valuation (insula, orbitofrontal cortex) during a period of SR relative to HS. These
responses will be correlated with intakes of high carbohydrate and high fat foods (hypothesis 1a)
and [ghrelin]. Connectivity of the networks involved in reward valuation at rest will be stronger after SR
compared to HS and synchrony of the DMN will be reduced after SR compared to HS.Sp. Aim 3:
Hypothesis 3a. SR will lead to [increased glucose, insulin, triglycerides, and reduced highdensity lipoprotein
cholesterol and adiponectin relative to HS.] We will perform repeated measure linear mixed model analyses
separately for each of glucose, insulin, triglycerides, high-density lipoprotein cholesterol and adiponectin.
Sleep duration (SR vs. HS) and the covariates will be used as independent variables. Subject will be used
as a random effect. One-sided paired t-test and Wilcoxon test will also be used to determine whether the
SR and HS have different effects on the cardio-metabolic risk profiles, as well as the direction of the
effects. Hypothesis 3b. Increased adiposity and poor diet quality (higher fat and carbohydrates) after SR will
partially explain the adverse cardio-metabolic risk profile associated with SR. We will select the
cardiometabolic risk profile variables that are adversely associated with SR. Then, we will compute the
difference in those variables in SR vs. HS (i.e. the value of each variable in SR minus the value of that
variable in HS).  Using a linear model analysis, we will test if these differences are associated with
increased adiposity and poor diet quality. If, for some variables, there are multiple observed differences for
each subject then a linear mixed model analysis will be used with subject as a grouping variable. A
separate analysis will be performed for each such difference, with the difference as the response variables
and adiposity, food quality variables and the covariates as dependent variables.   Linear Mixed Model
Analyses.We will fit a linear mixed model to analyze the data. Treatments (SR vs. HS) will be used as fixed
effects and subject will be used a random effect. The other independent variables, such as demographic
variables, will be covariates. Those covariates will be removed if they do not significantly contribute to the
model.Aim 4: (To determine whether long-term mild SR, relative to HS, challenged acute cognitive
outcomes in older and younger adults. Hypothesis 4a. Mild SR will induce cognitive decline, assessed using
with the NIH Toolbox, which will be greater in older relative to younger adults.) Outcomes are measures
from the NIH Toolbox. Each outcome will be analyzed in separate linear mixed model analyses, for older
and young participants, as detailed in “Linear Mixed Model Analyses” section above. Sleep (SR vs. HS),
along with phase (1 vs. 2), carryover effects, and covariates (if they are found to be significant in an initial
analysis) will be used in the model. Subject will be used as a random effect. Then, we will pool the datasets
to include both older and young participants. In the pooled dataset, we will use the average differences in
NIH Toolbox measures (from HS to SR) as outcomes in linear model analysis. Age group (older vs.
younger) will be used as main predictor variable. We will also apply covariates as independent variables, if
they are found to be significant in an initial analysis. We will use unpaired t-test on the average difference in
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NIH Toolbox measures (from HS to SR), to test if these values are significantly different between older and
young participants.Aim 5: (To determine whether the effects of SR on cognitive outcomes are moderated by
brain atrophy in younger and older adults. Hypothesis 5a. The effect of mild SR on cognition will be greater
among individuals with greater amounts of cortical thinning, smaller hippocampi, and greater WMH volume.
This effect will be greater in older relative to younger adults.) Separately for older and young participants,
we will perform linear model analyses, with average differences in NIH Toolbox measures (from HS to SR)
as outcomes (separately for each outcome). Cortical length, hippocampi size and WMH volume will be used
as independent variables. We will apply covariates as independent variables, if they are found to be
significant in an initial analysis. Then, we will pool the datasets to include both older and young participants.
In the pooled data, we will perform linear model analyses, with average differences in NIH Toolbox
measures (from HS to SR) as outcomes. Cortical length, hippocampi size, WMH volume and age group
(older vs. younger) will be used as independent variables. We will also use covariates as independent
variables, if they are found to be significant in an initial analysis.Aim 6: (To determine whether changes in
metabolic or hormonal profiles mediate changes in cognitive function as a result of SR. Hypothesis 6a. The
effect of mild SR on cognition will be mediated by changes in hormones (leptin, adiponectin, and insulin).)
Separately for older and young participants, and separately for each hormone measure, each outcome
(from NIH toolbox) will be analyzed with mediation analysis (Baron and Kenny's method). Sleep type (SR.
vs HS) will be the predictor in the analysis. Hormone measure will be used as the potential mediator. As we
have multiple measures from each participant, each component analysis in Baron and Kenny's method will
be done as linear mixed model analysis, with subject as random effect. Within each mediation analysis, the
first analysis will only have one fixed effect: sleep (SR vs. HS). The outcome measure will be the dependent
variable. If sleep is found to be significant, then the second analysis will be done with the hormone measure
as the dependent variable, and sleep as the fixed effect. If sleep is also found to be significant in the second
analysis, then in the final analysis, the outcome measure will be the dependent variable. Fixed effects will
be sleep and the hormone measure. If the hormone measure is still found to be significant, and the
coefficient of sleep has decreased in absolute value from the first analysis, then a mediation effect of
hormone will be concluded. 
 
 
Is the purpose of this submission to obtain an exemption determination, in accordance with 45CFR46.101(b):  
No
  
Is the purpose of this submission to seek expedited review , as per the federal categories referenced in
45CFR46.110?
No
 
 
Is there any external funding or support that is applied for or awarded, or are you the recipient of a gift, for this
project?
Yes
Exempt and Expedited
Funding
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Award Type
Funding
Source
Name
Name of
awarding
agency
Status
Award # or
Application
Date
Federal/State
/Local
Government
Direct or
Subcontract
What is the
award
covering?
Rascal PT
Number
Federal/State/
Local
Government
NIH
National
Heart, Lung,
and Blood
Institute/NIH/
DHHS
Awarded/Rec
eived
R01HL12822
6
Direct
Recipient:
With
Subcontract
Sites
Entire
Protocol
PT-
AABL8020
Subcontract site(s), procedures taking place at each site and FWA# for federally funded studies:
NYULMC performs fMRI measurements; University of Manitoba is analyzing doubly-labeled water
samples
Locations
Location Type
Facility Name
Domestic or
International
Geographic
Location
Local IRB Ethics
Approval
Local Site
Approval
Columbia/CUMC
21 Audubon
Avenue, basement
Columbia/CUMC
Neurological
Institute, Basement
Columbia/CUMC
NYP 10
Columbia/CUMC
Russ Berrie
Personnel
UNI/Phone
Name
Role
Department
Edit/View
Obtaining
Informed Consent
ms2554
212-851-5578
St Onge, Marie
Pierre
Principal
Investigator
MED General
Medicine
(751880X)
Edit
Y
amb2139
212-342-1378
Brickman, Adam
Investigator
TBI Cognitive
Neuroscience
(7581305)
Edit
N
Roles and Experience:  Neuroimaging and neuro-cognitive testing
as4874
917-968-3208
Shechter, Ari
Investigator
MED Behavioral
Cardiology
(751890X)
Edit
Y
bbl14
212-851-5562
Laferrere, Blandine Other Engaged
Personnel
MED Obesity
(752060X)
View
N
Roles and Experience:  medical supervision
bc2159
212-342-1238
Cheng, Bin
Investigator
BST Biostatistics
(821000X)
View
N
Roles and Experience:  statistical analyses
cwb11
212-305-1742
Bazil, Carl
Investigator
NEU Epilepsy
Operations
(7524502)
View
N
fmz2105
724-549-7905
Zuraikat, Faris
Other Engaged
Personnel
MED General
Medicine
(751880X)
Edit
Y
Roles and Experience:  Post-Doctoral Fellow; expertise in data analyses
IRB-AAAQ7746
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UNI/Phone
Name
Role
Department
Edit/View
Obtaining
Informed Consent
gb2710
845-548-3569
Benasi, Giada
Other Engaged
Personnel
MED General
Medicine
(751880X)
Edit
N
Roles and Experience:  New post-doctoral fellow
kci2104
281-300-6376
Igwe, Kay
Other Engaged
Personnel
ENG PROF
CHRISTOPH
JUCHEM LAB
(5218209)
View
N
Roles and Experience:  Neuroimaging and neuro-cognitive testing
mep2238
520-909-1711
Petrov, Megan
Other Engaged
Personnel
MED General
Medicine
(751880X)
View
N
Roles and Experience:  sleep and health, data analysis
ws2003
212-851-5572
Shen, Wei
Investigator
PED
Gastroenterology
(754110X)
View
N
Training and COI
The PI must ensure that each individual that is added as personnel has met the training requirements for this
study (http://www.cumc.columbia.edu/dept/irb/education/index.html). For help identifying which research
compliance trainings you may be required to take, visit the Research Compliance Training Finder.
UNI
Name
COI
HIPAA
HSP
(CITI)
Resear
ch with
Minors
(CITI)
FDA-
Regulat
ed
Resear
ch
(CITI)
S-I
CRC
Good
Clinical
Practic
e (GCP)
GCP -
Third-
party
trackin
g
GCP
Refresh
er
Genetic
Resear
ch
Consen
t
ms2554 St
Onge,
Marie
Pierre
04/10/2
023
12/20/2
013
04/06/2
022
06/18/2
019
06/18/2
019
09/09/2
022
amb213
9
Brickma
n, Adam
04/07/2
023
12/02/2
004
12/28/2
022
12/28/2
019
12/21/2
012
12/21/2
012
11/28/2
022
as4874
Shechte
r, Ari
05/24/2
023
10/27/2
011
06/26/2
023
07/25/2
011
09/23/2
020
08/02/2
022
bbl14
Laferrer
e,
Blandin
e
01/04/2
024
07/16/2
020
12/08/2
022
06/16/2
017
06/23/2
014
09/29/2
014
01/31/2
023
bc2159
Cheng,
Bin
01/12/2
024
10/20/2
004
01/11/2
023
01/11/2
023
01/11/2
023
05/15/2
022
cwb11
Bazil,
Carl
01/17/2
024
07/09/2
004
09/06/2
022
09/29/2
006
02/03/2
017
09/06/2
022
fmz210
5
Zuraikat
, Faris
01/16/2
024
09/07/2
018
10/16/2
021
09/07/2
018
03/19/2
020
03/15/2
023
03/15/2
023
10/25/2
021
gb2710
Benasi,
Giada
06/09/2
023
01/05/2
020
10/05/2
022
07/20/2
021
07/20/2
021
10/06/2
022
10/05/2
022
10/25/2
021
kci2104 Igwe,
Kay
11/13/2
023
02/26/2
015
01/13/2
023
03/03/2
021
03/03/2
021
mep223
8
Petrov,
Megan
06/02/2
023
01/12/2
024
12/19/2
023
11/29/2
023
12/21/2
023
ws2003 Shen,
Wei
11/15/2
023
04/17/2
014
05/20/2
021
05/19/2
021
08/13/2
018
12/29/2
022
Departmental Approvers
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Indicate the methods by which data/research records will be maintained or stored (select all that apply):
[x]Hardcopy (i.e., paper)
Describe where and how the data will be stored:
All files with participant identifying information will be kept in a locked file cabinet in the PI's office
[x]Electronic
Where will the data be stored?
Y
[x]On a System
[x]On an Endpoint 
 Identify what type of endpoint will be used (select all that apply): 
[x]Desktop Computer 
[x]Laptop Computer 
[  ]Mobile Device  
[  ]Other
Does this study involve the receipt or collection of Sensitive Data?
Yes
If any Sensitive Data is lost or stolen as part of your research protocol, you must inform both the IRB and the
appropriate IT Security Office (CUMC IT Security if at CUMC; CUIT if at any other University campus).
 
What type of Sensitive Data will be obtained or collected? Select all that apply:
[x]Personally Identifiable Information (PII), including Social Security Numbers (SSN)
Will Social Security Numbers (SSNs) be collected for any purpose?
Yes
Describe the purpose for collection of SSNs:
subject payment
Describe the plan to protect SSN confidentiality:
w-9 forms will not be stored with subject data
Will SSNs be disclosed outside of Columbia for any purpose?
No
[x]Protected Health Information (PHI), including a Limited Data Set (LDS) 
If any PHI is lost or stolen, you must inform both the IRB and the Office of HIPAA Compliance.
 
 
Indicate plans for secure storage of electronic sensitive data: check all that apply
[  ]Sensitive data will not be stored in electronic format
[  ]Sensitive data will be stored on a multi-user system
Electronic Signature:  Megan Petrov (751880X) - Other
Engaged Personnel
Date:  12/11/2023
Electronic Signature:  Bin Cheng (821000X) - Investigator
Date:  01/08/2024
Electronic Signature:  Marie Pierre St Onge (751880X) -
Principal Investigator
Date:  01/16/2024
Privacy & Data Security
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[x]Sensitive data will be stored on an encrypted endpoint
 
 
By Selecting an Endpoint Device and approving this protocol for submission to the IRB, the PI is attesting that
the device and any removable media that may be used have been or will be registered and/or will be
maintained in compliance with the University's Information Security Charter and all related policies. It is
important that this information is updated, during the course of the study, as new devices are added.
Provide a description of how the confidentiality of study data will be ensured, addressing concerns or
protections that specifically relate to the data storage elements identified above (e.g. hard copy, electronic,
system, and/or endpoint):
Data files will be password protected and exchanged in secured servers. Only individuals involed in the study conduct will
have access to those files and HIPAA regulations will be followed. All data transmitted among investigators will be coded
and shared via encrypted devices.  Data obtained via mobile devices (e.g., tablets) will not contain PII/PHI, and will be
transferred to secure endpoints via the CUMC athens wireless network, or otherwise via a physical connection (e.g. USB,
microSD).
 
If your project is not NIH funded, has a Certificate of Confidentiality (CoC) been requested for this research?
No
Provide a description of the protections in place to safeguard participants' privacy while information is being
collected:
Data files will be password protected and exchanged in secured servers. Only individuals involed in the study conduct will
have access to those files and HIPAA regulations will be followed. All data transmitted among investigators will be coded
and shared via encrypted devices. Data obtained via mobile devices (e.g., tablets) will not contain PII/PHI, and will be
transferred to secure endpoints via the CUMC athens wireless network, or otherwise via a physical connection (e.g. USB,
microSD).
 
 
Is this project a clinical trial?
Yes
Is this project a clinical trial that requires registration with www.clinicaltrials.gov?
Yes
Has this study been registered with www.clinicaltrials.gov?
Yes
Please provide the registration number:
NCT02960776
Is this project associated with, or an extension of, an existing Rascal protocol?
No
Do study procedures involve any of the following?
Analysis of existing data and/or prospective record review
No
Audio, video or photographic recording of research subjects
No
Behavioral Intervention?
Procedures
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Yes
Biological specimens (collection or use of)
Yes
Cancer-related research
No
Drugs or Biologics
No
Future use of data and/or specimens
Yes
Genetic research
No
Home Visits
No
Human Embryonic and/or Human Pluripotent Stem Cells
No
Imaging procedures or radiation
Yes
Medical Devices
Yes
Surgical procedures that would not otherwise be conducted or are beyond standard of care
No
Will any of the following qualitative research methods be used?
Survey/interview/questionnaire
Yes
NOTE: You must attach a PDF version of the survey(s)/interview(s)/questionnaire(s) to this protocol prior
to submission.
Systematic observation of public or group behavior
No
Program evaluation
No
Will any of the following tests or evaluations be used?
Cognitive testing
Yes
Educational testing
No
Non-invasive physical measurements
Yes
Taste testing
No
Is there a stand-alone protocol that describes ALL procedures in this study?
No
Please describe ALL study procedures in detail.
NOTE: Be sure to detail all of the procedures above to which a "yes" response was selected. Also detail any
additional procedures that may or may not fall into the categories listed above.
 
Overview of Procedures
We propose a randomized, crossover, outpatient sleep restriction study with 2 phases of 6 wk each. The sleep
durations will be the participant’s regular bed- and wake-times during the HS phase and HS minus 1.5 h in the SR
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phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep
schedule. During the SR phase, participants will be asked to keep their habitual wake time constant but delay their
bedtime to achieve a reduction of 1.5 h in total sleep time. A delay in bedtimes was chosen rather than advancing
wakeup time because it most closely reflects differences in sleep timing behavior between short and habitual sleepers.
In fact, the longer sleep duration of individuals in the Central time zone compared to that of those in Eastern or Pacific
time zones [58] is hypothesized in part to be due to late night shows being broadcast one hour earlier in the Central
time zone [59]. Individuals in Eastern or Pacific time zones stay up later at night to watch those shows. Adolescent
short sleepers have later bedtimes than normal sleepers [60]. Moreover, delaying bedtimes increases exposure to light
at night which is associated with weight gain and obesity [61]. Providing individualized bedtimes and wakeup times for
each participant was chosen to ensure that participants are not phase-shifting their sleep episode for the purpose of
this study. Two weeks prior to randomization and during washout periods, participants will wear an actigraph
(ActiGraph wGT3X-BT activity monitor, Pensacola, FL) and keep a sleep diary to verify sleep duration and sleep-wake
schedule. In addition to achieving an average sleep of 7-9 h/night, per wrist actigraphy, participants will only be
enrolled if they achieve 7 h of sleep for at least 10 of the 14 nights of screening and have <4 nights with <6 h of sleep.
We have successfully used this screening protocol in several studies [8, 28].  The actigraph monitors will be provided
by the research team.  At randomization, a urine pregnancy test (for women) and drug screen will be performed.
Participants will be asked to abstain from caffeine and alcohol intake for 24 h prior to the start of each study phase.
Between study phases, if participants have not returned to baseline sleep patterns, an additional 2-4 wk washout
period will be provided. In general, washout periods will be 6 wk in duration. This washout length enhances the
likelihood that women will be in the same phase of their menstrual cycle at the start of each experimental phase
On the first day of each study phase (baseline), participants will come to Irving Center for Clinical and Translational
Research (CTSA) at Columbia University in the morning after an overnight, 12-h fast. Participants will have
anthropometric and blood pressure measurements taken, will provide a fasting blood sample, undergo
performance/vigilance testing, and will then be taken to the department of Radiology to undergo MRI scanning to
assess body composition. Participants will begin the fixed bedtime routine that night. These baseline measurements
will be repeated at endpoint, 6 wk later.  Body weight, waist circumference, and blood pressure will be measured
weekly, fasting blood and urine samples will be taken at baseline, week-3, week-4, and endpoint, during adherence
check visits.  A non-fasting blood sample will be taken at week-5 adherence check visits.  During the last week of each
phase, 1 h before the participant’s self-reported usual dinner time they will be escorted to NYU for an fMRI.  They will
fill out a visual analog scale and the Stanford Sleepiness Scale, before and after the scan.  During the last week of
each phase, participants will undergo performance testing (6-minute walking test).
 
Ensuring adherence to the sleep protocol.
Participants will be blinded to the purpose of the study to ensure that they do not alter their habits by knowing the
hypothesis that SR may cause weight gain. Participants will be told that the purpose of the study is to assess the
effects of mild SR on mood and cognitive and physical performance. Questionnaires and physical performance tests
will be administered at baseline and bi-weekly, to maintain blinding.  We also have a well-defined strategy for ensuring
adherence to the sleep protocol in this outpatient setting. Participants will be given written instructions on study
procedures and investigator phone calls will be made as reminders of the bedtimes and wakeup times on a weekly
basis. To verify that participants adhere to the sleep protocol, they will be asked to keep a sleep diary and wear an
activity monitor 24 h/d. Participants will wear an actigraphy monitor on their wrist (ActiGraph wGT3X-BT activity
monitor, Pensacola, FL), which will serve to track their sleep duration, sleep timing, and ambient light. This watch is
water resistant and therefore does not need to be removed to shower or swim. To further ensure compliance with the
sleep protocol, participants will be required to come to the research center on a weekly basis. This weekly visit will
serve several purposes: (1) download data from the Actiwatch (verify sleep duration); (2) charge the watch; (3) obtain
weekly diaries (verify bedtimes and wakeup times) and other questionnaires; (4) obtain body weight measurement and
blood and urine samples. Participants will be told a priori, as part of the screening process, that they must adhere to
the sleep protocol to continue to participate in the study and that adherence will be checked weekly. Non-adherent
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participants will be terminated from the study. Adherence will be defined as having bedtimes and wake times within 30
min of scheduled times at least 5 d/wk and achieving an average of >7 h of sleep each week with no more than one
night/wk of sleep <7 h during the HS phase and achieving an average sleep reduction of 1.5 h from screening sleep
duration each week with no more than one night/wk with <1.5 h of restriction during the SR phase. Daytime naps will
not be permitted. Participants will receive weekly incentives, in the form of a gift card, for their continued adherence to
the sleep protocol.
 
Detailed methods for outcome variables
 
Body composition measurements.
Anthropometric measurements will be obtained at the NYORC Human Phenotyping/Body Composition Core
Laboratory (Dympna Gallagher, Ed.D. Core laboratory Director). A single trained technician will obtain all
measurements for this study using laboratory standard procedures. Height, weight, and body circumferences (waist
and hip) will be measured in duplicate with the participant wearing only a hospital gown and no shoes. The Body
Composition Laboratory is a world-renowned center for the measurement of body composition and has been involved
in cutting-edge research for the development of new body composition assessment techniques, estimation equations,
and validation of new measurement tools.
 
Body composition will be measured by MRI at baseline and endpoint. Briefly, a full body scan will be done using a 1.5T
GE MRI (GE Healthcare) in the Department of Radiology at Columbia University Medical Center. We acquire 10 mm
thick slices at 40 mm intervals throughout the body. All body compartments will be segmented at the New York Image
Analysis Laboratory (Wei Shen, MD, Core laboratory Director) by trained technicians, who regularly undergo quality
control and cross-validation, using SliceOmatic image analysis software (Tomovision, Montreal, Canada). Technicians
will be blinded to sleep study phase assignment and test dates. This protocol will allow us to quantify muscle mass,
organ mass, and subcutaneous, visceral, and intermuscular adipose tissues for the whole body and for left and right
sides and upper and lower body. MRI provides images of the entire visceral area, a major advantage over other
imaging techniques. Another advantage of this methodology is the lack of radiation exposure and whole-body
measurements of visceral and subcutaneous adipose tissues. As MRI scanning is very safe, repeated measurements
can be performed frequently on the same individual. In this study, we chose to perform a whole-body scan rather than
the common single-slice imaging as we have shown that multi-slice imaging was better and more cost-effective at
detecting changes in visceral and subcutaneous adipose tissue than a single slice.  In the present
study, participant costs are higher than imaging costs. Therefore choosing a more precise body composition
assessment method that reduces the need for additional participants represents a cost-saving option. 
 
 
Energy expenditure.
EE will be assessed using doubly labeled water (DLW), during the last 2 wk of each sleep phase. At the 4-wk
compliance check, participants will be asked to provide a urine and a saliva sample prior to taking a dose of DLW (1.6
- 2.5 g 18O, 10% atom percentage excess [APE] and 0.12 g 2H2O 99.9% APE per kg estimated body water). This will
be followed by a 50 mL water rinse. Participants will be asked to minimize food and beverage consumption over the
following 4 h and to collect saliva samples at 3 and 4 h post-dosage. Participants will be given vials to collect these
samples as well as cups to collect second void urine samples at 24 h, 7 d, and 14 d post-dosing. Participants will be
asked to freeze their samples at home and bring them to the research center at the next compliance check visit.
Isotope measurements will be made by Off-Axis Integrated Cavity Output Spectroscopy in the laboratory of Dr. Edward
Melanson (Anschutz Medical Campus, University of Colorado, CO). These measurements will be obtained in younger
adults only.
We will also assess physical activity level by waist actigraphy (GT3X Actigraph LLC, Pensacola, FL) throughout each
study phase. We hypothesize that total EE and physical activity level will be lower during the period of SR compared to
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HS.
 
 
Resting-state and food-viewing stimulated neural activity.
Brain responses will be assessed using two fMRI paradigms (resting state and task-based) at wk 6, 1 h before the
participant’s self-reported usual dinner time. The resting state paradigm and intrinsic functional connectivity (iFC)
analysis will assess treatment effects on reward and interoception-related neuronal circuitry.  During the resting state
scan (2 runs, each ~ 5 mins), participants will focus on the fixation cross in the center of the screen. Wakefulness and
compliance with eyes-open instructions will be monitored via an eye-tracking camera and verbal reminders given
before every run. Pulse and respiration rates will be measured using MRIcompatible non-invasive physiological
monitoring equipment. Recent data by Fang et al. [71] reported altered resting state striatal connectivity after a night of
total sleep deprivation, which was correlated with increases in EI. We will explore whether this is the case in the
proposed conditions. The task-based paradigm has been validated in several studies, including our Sleep Study.  The
2-by-2 block design protocol includes 4 runs (~3 min each) each consisting of 4 blocks (2 foods and 2 non-foods)
during which participants view 5 items presented for 4 s each (total=20 s) using E-Prime 2 (Psychology Software
Tools, Inc., Pittsburgh, PA). Each block is separated by a 20 s basal period during which participants view a fixation
cross. [The order of blocks in a run is constant for each participant with the specific stimuli that the individual ranked
highest in a preference rating questionnaire prior to scanning. Our pilot R56 grant data (R56 HL119945) suggested a
relatively uniformly distributed range of preferences across the initial 40 food and 40 non-food items that each
participant ranked. This preliminary finding supports the feasibility of including images that are rated as “mildly
appealing” up to “very appealing”.] Importantly, in our previous Sleep Study, scanning was performed in the fasted
state in the morning. Since it has been proposed that SR induces greater evening intakes specifically, we chose to
perform our measurement approximately 1 h prior to the participant’s usual dinner, a time when individuals may be
most susceptible to be hyper-responsive to food stimuli in SR relative to HS, thus increasing sensitivity for capturing
the effect of SR.
 
Imaging parameters.
fMRI scanning will take place at the NYULMC Center for Biomedical Imaging using [the same Siemens 3T Skyra
scanner (Siemens USA, Malvern, PA) used in our R56 pilot study.] Head motion will be minimized by placing restraint
pads around the head. A T1-weighted anatomical image [(MPRAGE sequence: TR=1900 ms; TE=2.52 ms; TI=900
ms; flip angle=9°; 176 slices, FOV=250 mm, voxel size=1x1x1 mm) will be acquired for image co-registration and
spatial localization. For both resting-state and task-based paradigms, functional data will be acquired using a single-
shot gradient echo planar imaging (EPI) T2*-weighted sequence (TR=2500 ms; TE=30 ms; Flip angle=80°, 38 slices,
matrix=64x64; FOV=216 mm; voxel size=3x3x3 mm).] To examine structural connectivity, we will acquire diffusion-
weighted data using an echo-planar sequence (TR=5.2 s, TE=78 ms, 32 directions, b=1000 s/mm2; acquisition voxel
size=2x2x2 mm).
 
Image analysis.
Image processing will be carried out using [FMRIB Software Library (FSL, www.fmrib.ox.ac.uk) and Configurable
Pipeline for the Analysis of Connectomes (C-PAC, http://fcpindi.github.com).] Preprocessing will comprise (1) slice
time correction, (2) 3-D motion correction, (3) spatial smoothing (FWHM=6 mm), (4) mean-based intensity
normalization, (5) temporal band-pass filtering (restingstate data only; 0.009-0.1 Hz), and (6) linear and quadratic
detrending. Linear registration of each participant’s functional time series to their high-resolution structural image and
non-linear registration of high-resolution structural images to the Montreal Neurological Institute (MNI) template with 2
mm resolution will be performed using FLIRT and FNIRT [73, 74]. [Given that head motion in 100% of our preliminary
task-related and resting state data was much lower than field standards (mean head motion for each of the 4 task and
2 rest functional runs ranging between 0.073 mm and 0.078 mm, substantially lower than the field standard of 0.2
mm), we anticipate implementing ‘scrubbing’ to salvage offending segments with excessive motion, if necessary. Task:
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Neural responses during food and non-food blocks will be assessed using a box-car convolved with a hemodynamic
response function (HRF) as implemented in FEAT [78]. A direct contrast of food relative to non-food blocks will identify
brain regions sensitive to food processing. Group-level random-effects analyses will compare neural activation for
food>nonfood stimuli using paired t-test between HS and SR. Whole-brain correction for multiple comparisons will be
performed (Z>2.3; cluster significance: p<0.05, corrected).   Finally, we will use resting state and task-based data to
assess activity of the DMN (regions of the posterior cingulate gyrus, medial prefrontal cortex, inferior parietal lobule,
lateral temporal cortex, and hippocampus).
 
Resting-state and food-viewing stimulated neural activity will be measured in younger adults only.
 
Appetite & food intake measurements.
Throughout the study, participants will self-select their food intake in a freeliving situation. Food intake will be assessed
at baseline, wk 3, and wk 6 by 3-d food records (2 weekdays and one weekend day) using a free electronic app, such
as MyFoodCircle, HealthWatch 360, or other similar app; or on paper. Participants could be asked to provide pictures
of their food to assist in data collection. In the proposed study, we are interested in qualitative assessment of diet and
comparison of intakes between phases. Nonetheless, quantitative assessments will also be available. Since
participants will be blind to the true objective of our study, we do not expect reporting error to systematically vary
based on study phase and can have confidence in our measurement tool. The within-subject study design is essential
in this regard. Moreover, the true assessment of energy balance is change in body composition: weight gain invariably
signifies positive energy balance whereas weight loss represents negative energy balance.  Energy and macronutrient
intakes will be assessed using the University of Minnesota Nutrition Data System for Research (NDSR, Minneapolis,
MN).
 
Assessment of metabolic parameters.
Fasting blood samples will be taken at baseline, wk 3, wk 4, and endpoint of each sleep phase for measuring lipid
profile, glucose, insulin, adiponectin, leptin, ghrelin, and GLP-1. [92]. All samples will be analyzed in the Hormone and
Metabolite Core laboratory of the NYORC (Dr. F. Xavier Pi-Sunyer, Core laboratory Director) by skilled technicians.
Insulin will be assayed using a radioimmunoassay (RIA; Linco Research Products Inc., St. Charles, MO; mean inter-
assay CV 4.5% [93, 94]). Serum leptin will be measured using a double-antibody RIA (Linco Research; inter-assay CV
6.8% [93, 94]). Cortisol will be assay using enzyme immunoassay (DPC, Los Angeles, CA). 6-Sulfatoxymelatonin will
be assayed from morning urine samples as a proxy for overnight melatonin production [95] using ELISA kit (ALPCO,
Salem, NC). Blood samples will be collected in EDTA-coated chilled tubes for measuring peptide hormones. The tubes
will be pre-treated with addition of aprotinin (0.6 TIU/mL of blood) and DPP-IV inhibitor (10 L/mL of blood) to prevent
hormone degradation. Total ghrelin will be assessed using RIA (Linco Research; inter-assay CV 6.3% [96]).
Adiponectin levels will be analyzed using RIA (Linco Research). GLP-1 will be assessed using RIA (Phoenix
Pharmaceutical, Belmont, CA).  An additional blood sample will be collected in silica-coated serum separating tubes to
measure thyroid stimulating hormone, free T4, and sex hormones (testosterone, estrogen, progesterone, FSH, and
LH).
 
Questionnaires.
In addition to the screening questionnaires, several questionnaire will be administered at baseline and endpoint of
each phase.
1) The SF-36v2 health questionnaire will provide an objective measure of quality of life over the course of each phase.
2) Similarly, the Montreal Cognitive Assessment (MOCA), the NIH Toolbox, and the ModRey will be administered at
baseline and endpoint of each phase to evaluate general cognitive function. Any findings of cognitive impairment will
be disclosed to the research participant.
3) Although the caffeine consumption questionnaire is initially administered as a screening tool (must consume <300
mg/day), we will also administer it at baseline and endpoint of each phase to assess changes in caffeine consumption.
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4) Perceived Stress Scale 10-item and the Hospital Anxiety Depression Scale-Anxiety sub scale will be administered
at baseline, wk 3, and 6 of each phase.
 
Performance tests.
During the last week of each study phase, preferably on the 5th follow-up visit (the 7-d visit after DLW dosing),
participants will undergo a 6-min walking test.  This test will be administered in the CRR on a 30-m walking course.
Participants will be instructed to walk as fast as possible to cover the most distance over a 6-min period.  The research
assistant will provide information on time remaining at each minute.
The psychomotor vigilance test (PVT) will be administered at baseline, week 3, and week 6, using an app on an
Android tablet.  This test will be done at the time of the blood sampling procedure.
 
Structural brain imaging.
Structural brain imaging MRI protocol. MRI scanning will take place on a 3T Philips Achieva scanner located at
Columbia University Irving Medical Center. This procedure will take place in conjunction with the whole-body scan that
is currently performed in the parent study and will only be performed at baseline of phase 1. The protocol derives
measures of brain atrophy/volumetry and WMH, but we will also examine microbleeds and infarcts for secondary
analyses. Table 1 displays the pulse sequences collected for this study. Scanning takes place in a single session and
includes a high-resolution T1-weighted anatomical scan (MPRAGE), T2-weighted FLAIR, and gradient echo (GRE).
We also collect diffusion-weighted imaging and diffusion tensor imaging data for secondary or exploratory analyses.
The MRI data will be transferred to a PACS for clinical review and via established, secure DICOM servers the data are
also transferred to Dr. Brickman’s laboratory for analysis.
 
Global and regional atrophy. Using each individual’s T1-weighted image, structural imaging measures of both global
and regional brain volume and measures of cortical thickness are derived with FreeSurfer
(http://surfer.nmr.mgh.harvard.edu/). Primary volumetric measures will be hippocampal, entorhinal cortex, and total
brain volume. We will also assess cortical thickness as specific patterns of cortical thinning found in Alzheimer’s
disease [20, 46]. Again using Freesurfer software [47, 48], we will calculate mean thickness in 33 different gyral-based
areas in each hemisphere [49]. The primary cortical thickness measure [20, 46] will include the average thickness in
Alzheimer’s disease -related regions [50]. Volumetric and cortical thickness in all regions are databased for secondary
analyses.
 
Microbleeds. Microbleeds are rated by visual inspection following criteria put forth by Greenberg et al. [51-53]. The
primary measure is the presence or absence of lobar microbleeds, indicating possible or probable cerebral amyloid
angiopathy [54]. The number of microbleeds and location are coded and databased for each participant. 
Infarct. All available MRI data are used to define radiological infarcts. Infarcts are rated as discrete hypointense lesions
that are larger than 5mm surrounded by a complete hyperintense ring on FLAIR. The primary measure is presence or
absence of infarct, but several summary measures are generated, including number, size, and location.
 
 
Add an individual entry for each human specimen type that will be collected or utilized for the proposed study.
For each specimen type, indicate the source or sources from which you will obtain the specimens.
 
The use of specimens for research purposes may require that informed consent (or a waiver, if applicable) and
HIPAA Authorization (or a waiver, if applicable) be obtained from subjects.
Biological Specimens
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Type:
Saliva
Source:
[x] From Columbia and/or NYP Subjects/Patients or Repositories managed by Columbia
Select all that apply to this specimen type:
[x] Specimens will be prospectively collected specifically for this research.
[  ] Residual specimens from clinical care that would otherwise be discarded have been or will be collected.
[  ] Specimens to be analyzed will be (or have been) collected from a commercial source.
[  ] Specimens to be analyzed will be (or have been) collected under a separate CU IRB-approved protocol; this could
be an approved research repository protocol.
[  ] From Non-Columbia/NYP Subjects/Patients or Repositories not managed by Columbia
Description of Specimen and Method of Obtaining:
Participants will be given instructions and vials to collect urine samples at home and bring to research center at their
following visit.
Indicate the manner in which the specimens will be labeled:
[  ] Specimens will be labeled with direct identifiers
[x] Specimens will be labeled with a code and the research team has the key and can link specimens to direct identifiers.
This code would be considered an indirect identifier
[  ] The identifiers will be removed prior to the receipt of the specimens by Columbia researchers and no link will remain
[  ]  Specimens were originally collected without identifiers
 
If specimens are collected or received at any point in time as with direct or indirect identifiers by the current
researchers, then the specimens are considered to be identifiable, and the requirements for Informed Consent (or
a waiver, if applicable) and HIPAA Authorization (or a waiver, if applicable) apply. The necessary information will
need to be included in the respective sections of this Rascal submission.
Type:
Blood
Source:
[x] From Columbia and/or NYP Subjects/Patients or Repositories managed by Columbia
Select all that apply to this specimen type:
[x] Specimens will be prospectively collected specifically for this research.
[  ] Residual specimens from clinical care that would otherwise be discarded have been or will be collected.
[  ] Specimens to be analyzed will be (or have been) collected from a commercial source.
[  ] Specimens to be analyzed will be (or have been) collected under a separate CU IRB-approved protocol; this could
be an approved research repository protocol.
[  ] From Non-Columbia/NYP Subjects/Patients or Repositories not managed by Columbia
Description of Specimen and Method of Obtaining:
Blood samples by venipuncture 
Indicate the manner in which the specimens will be labeled:
[  ] Specimens will be labeled with direct identifiers
[x] Specimens will be labeled with a code and the research team has the key and can link specimens to direct identifiers.
This code would be considered an indirect identifier
[  ] The identifiers will be removed prior to the receipt of the specimens by Columbia researchers and no link will remain
[  ]  Specimens were originally collected without identifiers
 
If specimens are collected or received at any point in time as with direct or indirect identifiers by the current
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researchers, then the specimens are considered to be identifiable, and the requirements for Informed Consent (or
a waiver, if applicable) and HIPAA Authorization (or a waiver, if applicable) apply. The necessary information will
need to be included in the respective sections of this Rascal submission.
Type:
Urine
Source:
[x] From Columbia and/or NYP Subjects/Patients or Repositories managed by Columbia
Select all that apply to this specimen type:
[x] Specimens will be prospectively collected specifically for this research.
[  ] Residual specimens from clinical care that would otherwise be discarded have been or will be collected.
[  ] Specimens to be analyzed will be (or have been) collected from a commercial source.
[  ] Specimens to be analyzed will be (or have been) collected under a separate CU IRB-approved protocol; this could
be an approved research repository protocol.
[  ] From Non-Columbia/NYP Subjects/Patients or Repositories not managed by Columbia
Description of Specimen and Method of Obtaining:
Participants will be given instructions and cups to collect urine samples at home and bring to research center at their
following visit.
Indicate the manner in which the specimens will be labeled:
[  ] Specimens will be labeled with direct identifiers
[x] Specimens will be labeled with a code and the research team has the key and can link specimens to direct identifiers.
This code would be considered an indirect identifier
[  ] The identifiers will be removed prior to the receipt of the specimens by Columbia researchers and no link will remain
[  ]  Specimens were originally collected without identifiers
 
If specimens are collected or received at any point in time as with direct or indirect identifiers by the current
researchers, then the specimens are considered to be identifiable, and the requirements for Informed Consent (or
a waiver, if applicable) and HIPAA Authorization (or a waiver, if applicable) apply. The necessary information will
need to be included in the respective sections of this Rascal submission.
 
 
On the General Information page you have indicated that the protocol version associated with the use of this
medical device is as follows: Y1M1-Adm Suppl
 
Please note that a Protocol Version # is required for protocols using a medical device, and you will not be
allowed to submit this protocol until the Protocol Version # field is complete. Please ensure that the Protocol
Version # is completely and accurately reported on the General Information page. 
 
Please enter the requested information for each device that is the object of the study or is being used because it
is relevant to the aims of the protocol, whether the medical device is not yet FDA-approved [i.e., is
investigational] or is an approved device that is being used in an investigational manner (i.e., off-label use is
being studied). 
 
Note that the questions apply only to devices used in clinical investigations or protocols that involve a
Humanitarian Use Device. Emergency use of a device that is not yet FDA-approved is not a clinical investigation,
Devices
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and a submission in Rascal may not be required. Please contact the IRB for assistance if emergency use of a
device that is not yet FDA-approved is being considered: (212)305-5883. 
 
Device name:
Actigraphy monitor 
Device description:
Activity monitor worn on wrist to track sleep duration, sleep timing, and physical activity
Device Model/Version #:
wGT3X-BT
Phase of Study:
Pivotal
Manufacturer Information
Is the device a Humanitarian Use Device (HUD)?
No
Is the device FDA-approved and used in accordance with its labeling?
Yes
An Investigational Device Exemption (IDE) is not required. A copy of the instructions for use must be attached
in Rascal.
Will a representative of the Sponsor/Manufacturer be involved with the use of the device at Columbia/ NYPH, e.g.,
for training purposes?
No
 
 
For what materials do you anticipate future research use? Select all that apply.
[x]Data
[x]Biological Specimens
Please indicate how data and/or specimens will be retained for future use:
[x]Some or all data and/or specimens, as applicable, will be retained by Columbia researchers for future use.
How are the materials intended to be used for research in the future?
Multiple researchers, which may include the current PI and research team, will be able to request use of the
materials.
What is the intent for use of the materials? (Select all that apply.)
[  ]The intent is to add the materials to an existing CU repository (e.g., HICCC Tumor Bank). 
[x]The intent is to create a repository. 
Does this protocol describe the repository procedures?
No, the Columbia repository protocol has not yet been created
The repository protocol should be reviewed and approved by the IRB before material is
collected and ready to be entered into the repository
How will the data and/or specimens, as applicable, be labeled during storage for future uses.
[x]In the same manner as during collection (e.g., with direct identifiers, coded, de-identified, anonymous)
[  ]In a different manner than during collection. Select all that apply:
Name:
Actigraph Corp
Address:
49 East Chase Street. Pensacola, FL 32502
Contact information:
850.332.7900
Future Use
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Describe the physical storage for the specimens/data, including location.
[x]In the same manner as during collection
[  ]In a different manner than during collection
Describe who will have access to the stored data and/or specimens.
Investigators directly involved with the study and outside investigators upon request and agreement with
investigators.
[x]Some or all data/specimens will be released to a non-Columbia entity for future use and Columbia researchers will
not have direct control. 
Indicate to whom the data/specimens will be released
[  ]Sponsor
[  ]Non-Columbia repository
[x]Other
Describe
Dr. Edward Melanson at University of Colorado
Describe plans for release of data and/or specimens.
Specimens will be sent to Dr. Edward Melanson at the University of Colorado to be analyzed.  All specimens
will labeled in the same manner as during collection. (e.g., with direct identifiers, coded, de-identified,
anonymous)
 
 
Will a contrast agent (e.g. gadolinium) be used in conjunction with radiation exposure that goes beyond the
parameters established for the applicable standard of care (SOC), or will a contrast agent be administered for
research purposes only? The appropriate response would be 'no' if radiation exposure and use of contrast are
solely for SOC. 
No
 
 
For each type of radiation exposure (e.g., ionizing: CT, X-ray; non-ionizing: MRI), identify the procedure and
whether the administration (e.g., radiation dosage, number or type of scans) is clinically indicated and in
accordance with the parameters established for the applicable standard of care (SOC), or is "beyond" these
parameters (i.e., includes procedures or exposure for research purposes only). 
 
 
 
Procedure(s) Involving Ionizing Radiation
No data to display
 
 
Procedure(s) Involving Non-Ionizing Radiation
Imaging Procedures/Radiation Therapy
Procedure
The exposure to:
Location:
MRI
Beyond that established for the
applicable SOC
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Recruitment:
 
Will you obtain information or biospecimens for purposes of screening or determining eligibility?
No
 
Describe how participants will be recruited:
Potential participants will be recruited through local advertising media: flyers and posters in New York City, principally
Manhattan, where the study will be located. These will be posted in public spaces. We will also post flyers in and around
the hospitals of Columbia University Medical Center, and online on craigslist. NYPH and CUMC employees are not
excluded and can be enrolled if they respond to advertisement for the study.  However, they are not targeted, and will be
evaluated against the same criteria as the general population. We will follow identical practices to ensure the absence of
coercion into the study: participants will be told that participation in the study is completely voluntary and that they can
withdraw at any time without any penalty or prejudice and will not jeopardize their care at the hospital.
 
Select all methods by which participants will be recruited:
[  ]  Study does not involve recruitment procedures
[x]  Person to Person
[  ]  Radio
[  ]  Newspapers
[  ]  Direct Mail
[x]  Website
  URL: www.craigslist.org, www.studykik.com
[x]  Email
[  ]  Television
[  ]  Telephone
Procedure
The exposure to:
Location:
1. Will healthy pregnant subjects be enrolled and undergo MR scanning
procedures? No
2. Will healthy minor subjects be enrolled and undergo MR scanning
procedures? No
3. Will new or custom (i.e., non-FDA approved) imaging equipment be used? No
4. Will non-manufacturer provided pulse sequences be used that exceed the
'Normal Mode' or, for scanning of healthy subjects, the scanner '1st Level
Control Mode'? No
fMRI
Beyond that established for the
applicable SOC
1. Will healthy pregnant subjects be enrolled and undergo MR scanning
procedures? No
2. Will healthy minor subjects be enrolled and undergo MR scanning
procedures? No
3. Will new or custom (i.e., non-FDA approved) imaging equipment be used? No
4. Will non-manufacturer provided pulse sequences be used that exceed the
'Normal Mode' or, for scanning of healthy subjects, the scanner '1st Level
Control Mode'? No
Recruitment And Consent
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[x]  Flyer/Handout
[  ]  Newsletter/Magazine/Journal 
[x]  ResearchMatch
[x]  CUMC RecruitMe
 
Additional Study Information: Please add a description of your study as you would like it to be
displayed on the RecruitMe website.
We are currently looking for healthy, non-smoking, men and women (age 20-40 OR age 55-75 years) to
participate in an at-home sleep study.
 
You must be willing to come to the research center once a week during the entire duration of the study
(two separate 6-week periods). To participate you must regularly sleep 7-9 hours/night.
 
Compensation up to $2000-$2400, based on time-commitment and types of procedures, will be provided.
 
 
To see if you may be eligible, and for more information, please email Mehreen Bhatti, at
mzb2107@cumc.columbia.edu
 
Thank you.
  
Informed Consent Process:
 
Informed Consent Process, Waiver or Exemption: Select all that apply
 
[x]  Informed consent with written documentation will be obtained from the research participant or appropriate
representative.
 
Documentation of informed consent is applicable to:
The study in its entirety
 
Documentation of participation will be obtained from::
[x]  Adult participants
[  ]  Parent/Guardian providing permission for a child's involvement
[  ]  Legally Authorized Representatives (LARs)
 
Describe how participants' written consent will be obtained:
The Coordinator specifically trained in the screening procedures and who has undergone biomedical
research ethics training will be responsible for obtaining informed consent of each participant. Informed
consent will be obtained as a Consent Form requiring a signature. The Coordinator will explain all of the
details of the study, answer any questions that arise, and go over the scheduling and planning of the
procedures. The consenting process will explain the reason for the study, all of the experimental
procedures, the duration of the study, the collection and use of specimens, risks and benefits to the
participant, compensation, confidentiality, and the voluntary nature of the study to the participant. The
participant will be informed that they can interrupt the Coordinator at any time to ask questions, and will
be asked specifically at the conclusion of the consenting procedures if they have any remaining
questions on the experiment. The name, address, and phone number of the PI responsible for the study
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will be provided to the participant, and they will be able to contact the PI at any time throughout the trial
to ask any questions or address any issues that arise. Once interested individuals respond the posted
advertisements, they will be contacted by the Coordinator in charge of this study. A consent form
meeting will be scheduled at the offices where the research will be conducted (Columbia University
Medical Center). No screening measurements or experimental procedures will commence until the
participant provides informed consent. The duration of the consent form meeting will be roughly 1 hour.
The participant will have as much time as they require for decision making, and will be allowed to discuss
their choice of enrollment in the study with others before deciding to sign the consent form. Individuals
will be free to not take part in the study, or to discontinue their participation in the study at any time
during the study. 
 
[  ]  Informed consent will be obtained but a waiver of written documentation of consent (i.e., agreement to
participate in the research without a signature on a consent document) is requested.
 
[  ]  A waiver of some or all elements of informed consent (45 CFR 46.116) is requested.
 
[  ]  Planned Emergency Research with an exception from informed consent as per 21 CFR 50.24.
 
[  ]  This is exempt research.
  
Subject Language
Enrollment of non-English speaking subjects is not expected. 
 
During the course of the study, if non-English speaking subjects are encountered, refer to the IRB's
policy on the Enrollment of Non-English Speaking Subjects in Research for further details
(http://www.cumc.columbia.edu/dept/irb/policies/documents/Nonenglishspeakingsubjects.Revised.F
INALDRAFT.111909.website.doc
  
Capacity to Provide Consent: 
 
Do you anticipate using surrogate consent or is research being done in a population where capacity to
consent may be questionable? 
No
 
 
Research Question(s)/Hypothesis(es):
Aim 1: Does Longer, milder SR, as observed in individuals with SSD lead to positive energy
balance?Hypothesis 1a: SR will lead to increased total adipose tissue mass, as assessed using
MRI, relative to HS. We will perform repeated measure linear mixed model analyses separately for
adipose tissue mass increase and weight gain (as the response).Hypothesis 1b: EE, assessed by
doubly labeled water, and physical activity level, monitored daily by actigraphy, will be lower during
SR relative to HS.Aim 2: Is the increased EI observed in acute SR studies maintained over
time?Hypothesis 2a: EI, assessed by 3-d food records, will be greater during a period of SR
relative to HS. This will be mostly due to increased fat and carbohydrate intakes.Hypothesis 2b:
Neural responses to food stimuli, assessed by fMRI after 6 wk of SR or HS, will indicate increased
Research Aims & Abstracts
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activity in networks associated with reward and food valuation (insula, orbitofrontal cortex) during a
period of SR relative to HS. These responses will be correlated with intakes of high carbohydrate
and high fat foods (hypothesis 1a) and ghrelin. Connectivity of the networks involved in reward
valuation at rest will be stronger after SR compared to HS and synchrony of the DMN will be
reduced after SR compared to HS.Aim 3: Does Longer, milder SR, as observed in individuals with
SSD adverse cardiometabolic risk profile?Hypothesis 3a: SR will lead to increased glucose,
insulin, triglycerides, and reduced high density lipoprotein cholesterol and adiponectin relative to
HS.Hypothesis 3b: Increased adiposity and poor diet quality (higher fat and carbohydrates) after
SR will partially explain the adverse cardio-metabolic risk profile associated with SR. Aim 4. To
determine whether long-term mild SR, relative to HS, challenges acute cognitive outcomes in older and
younger adults.Hypothesis 4a.Mild SR will induce cognitive decline, assessed with the NIH Toolbox, which
will be greater in older relative to younger adults.Aim 5. To determine whether the effects of SR on
cognitive outcomes are moderated by brain atrophy and small vessel cerebrovascular disease in younger
and older adults.Hypothesis 5a.The effect of mild SR on cognition will be greater among individuals with
greater amounts of cortical thinning, smaller hippocampi, and greater WMH volume. This effect will be
larger in older relative to younger adults.  Aim 6. To determine whether changes in metabolic or hormonal
profiles mediate changes in cognitive function as a result of SR.Hypothesis 6a.The effect of mild SR on
cognition will be mediated by changes in hormones (leptin, adiponectin, and insulin).    
  
Scientific Abstract:
  Chronic sleep restriction (SR) is highly prevalent in today’s modern society and severe sleep
deprivation (SD) has been linked to obesity.  We our interested in establishing whether sleep could
be a causal factor in the etiology of obesity. In a recent meta-analysis, authors concluded that no
studies exist to assess the effects of long-term manipulation of sleep duration on obesity risk, and
proposed additional research using more standardized methods and measures, as well as
evaluations of associated outcomes with sufficient sample sizes to inspect this relationship. We
propose a randomized, crossover, outpatient sleep restriction study with 2 phases of 6 wk each.
Sixty-six men and pre-menopausal women, age 20-40 y, BMI 20-34.9 kg/m2 (with parent with BMI
>27 kg/m2 if participant BMI is 20-24.9 kg/m2), normal sleepers, free of any current and past sleep
and psychiatric disorders, diabetes or CVD will be recruited. During the habitual sleep (HS) phase,
participants will be asked to follow a fixed bedtime routine based on their screening sleep
schedule. During the SR phase, participants will be asked to keep their habitual wake time
constant but delay their bedtime to achieve a reduction of 1.5 h in total sleep time. Subjects will
have anthropometric measurements taken, will provide a fasting blood sample to examine
cardiovascular risk factors, and will then have body composition assessed at baseline and
endpoint using magnetic resonance imaging (MRI).   Body weight and waist circumference will be
measured weekly, fasting blood and urine samples will be taken at baseline, week-3, week-4, and
endpoint, during adherence check visits.  Doubly labeled water (DLW) will be given at week 4 of
each study phase will assess free-living energy expenditure (EE) and the continuous wear of
actigraph monitors will provide detailed information on physical activity levels as well as monitor
sleep duration.  At week 5 of each study phase, a non-fasting blood draw will be taken.  The
subjects will undergo an fMRI at the end of each phase to assess indices of neuronal activation of
brain reward and control centers under food-stimulated conditions.  Results of the proposed study
will determine whether SR can lead to weight gain, answering the key question of causality.
Furthermore, data will be able to generate novel hypotheses related to the role of sleep duration
IRB-AAAQ7746
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and energy balance on cardio-metabolic risk profile and results may provide additional knowledge
on which to base public health recommendations for obesity prevention efforts. 
  
Lay Abstract:
 Chronic sleep restriction (SR) is highly prevalent in today’s modern society.  Artificial light,
portable electronic devices and 24 hour services have allowed individuals to remain active
throughout the night, leading to reductions in total sleep time.  Our current state of knowledge
surrounding the relationship between short sleep duration (SSD) and obesity stems largely from
observational studies.  People who sleep less weigh more than normal sleepers and are at a
greater risk of obesity.  However, those studies cannot determine causality and are limited by
subjective measurements, such as self-reported sleep duration, which could lead to bias.  We are
interested in establishing whether sleep could be a cause of obesity.  This study will be a
randomized, crossover, outpatient study.  It will have 2 phases; each phase will be 6 weeks long. 
After the first phase, there will be a 6 week washout period before starting phase 2.  Sixty-six
healthy, men and pre-menopausal women at risk of overweight and obesity, age 20-40 y, who are
currently normal sleepers, will be recruited.  After an initial screening visit, they will wear an
actigraph monitor for 2 weeks prior to beginning the study to monitor their sleep and determine if
they are normal sleepers (sleep 7-9hours/night).  Then, they will be randomized (like a flip of a
coin) to either 1 of 2 phases: habitual sleep (HS) or sleep reduction (SR).   During the HS phase,
subject sleep duration will be their regular bed and wake times.  The SR phase will be their HS
time minus 1.5 h.  For example, if the participant’s habitual sleep is 8 h/night and they go to bed at
11:00pm, then during the SR phase they will sleep for 6.5h/night and go to bed at 12:30am.  At the
beginning and end of each study phase participants will have their height, weight, and waist and
hip circumference measurements recorded, a blood sample taken, and body composition
assessed using magnetic resonance imaging (MRI).  Body weight and waist circumference will be
measured weekly, fasting blood and urine samples will be taken at baseline, week-3, week-4, and
endpoint, during adherence check visits.  Sleep and physical activity level will be recorded using
actigraphy and assessed weekly.  At week 4 of each study phase, a dose of doubly-labeled water
(DLW) will be given to measure how many calories the subjects burn during regular day-to-day
life.  At week 5 a non-fasting blood draw will be taken during adherence check visit. An fMRI will be
done during week 6 of each study phase to look at neural responses to food stimuli.  Given the
increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in
sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide
additional ammunition in the fight to prevent further increases in the incidence of obesity. 
 
 
Abbreviated Submission:
The IRB has an abbreviated submission process for multicenter studies supported by industry or NIH
cooperative groups (e.g., ACTG, HVTN, NCI oncology group studies, etc.), and other studies that have a complete
stand-alone protocol. The process requires completion of all Rascal fields that provide information regarding
local implementation of the study. However, entering study information into all of the relevant Rascal fields is not
required, as the Columbia IRBs will rely on the attached stand-alone (e.g., sponsor's) protocol for review of the
overall objectives. .
Risks, Benefits & Monitoring
IRB-AAAQ7746
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If you select the Abbreviated Submission checkbox and a section is not covered by the attached stand-alone
protocol, you will need to go back and provide this information in your submission. 
  
Potential Risks:
Provide information regarding all risks to participants that are directly related to participation in this protocol,
including any potential for a breach of confidentiality. Risks associated with any of the items described in the
Procedures section of this submission should be outlined here if they are not captured in a stand-alone protocol.
Risks of procedures that individuals would be exposed to regardless of whether they choose to participate in this
research need not be detailed in this section, unless evaluation of those risks is the focus of this research. When
applicable, the likelihood of certain risks should be explained and data on risks that have been encountered in
past studies should be provided.
[  ]  Abbreviated Submission - This information is included in an attached stand-alone protocol. Proceed to the next
question
The major potential risks in this study are related to the sleep restriction, blood draw, and the MRI/
fMRI.1.  Risks associated with SR:Participants may feel sleepy and irritable during the SR phase.
They may feel drowsy, less attentive, or have difficult concentrating.2. Risks associated with blood
drawing:At the baseline visit and weeks 3, 4, 5, and 6, routine venipuncture will be performed for
screening laboratory studies, and on the oral glucose tolerance test days, an antecubital vein
catheter will be inserted in one arm for multiple blood sampling. Drawing blood and inserting an
intravenous line into an arm vein are safe and standard medical procedures. Sometimes a bruise
will occur at the puncture site and rarely a blood clot or infection will occur in the vein. Certain
individuals may feel light-headed during venipuncture. The volume of blood collected during this
study will be no more than 30 mL per time point.  This is not expected to have any serious negative
effects on a study participant.3. Risks associated with MRI and fMRI scanning:There are no
significant risks associated with the use of MRI except the risk of flying object in the magnetic field.
MRI scanning involves the use of a magnet and radio frequency waves (much like an ordinary
short-wave radio).-There are no known risks or adverse effects resulting directly from exposure to
magnetic fields and radio frequency signals used in this study, other than the potential risks
associated with the scanning procedure summarized below.-MRI uses a strong magnetic field to
create images of the body. Because of the strong magnetic field, the greatest risk is that a metal
object could be pulled into the scanner and hit someone.-Some people may feel confined and
experience anxiety in the scanner.-The scanner produces tapping sounds during operation, which
may reach very loud levels.-In extremely rare cases, a magnet can lose its magnetism, in which
case cooling fluids may be released noisily through escape valves and may collect in gas form in
the scan room. The gas is not harmful in itself as long as fresh air is available.-Some subjects may
experience muscle twitches or tingling sensation and/or a slight increase in body temperature
during some types of scan activity. These are very unlikely under current guidelines. 
  
Potential Benefits:
Provide information regarding any anticipated benefits of participating in this research. There should be a
rational description of why such benefits are expected based on current knowledge. If there is unlikely to be
direct benefit to participants/subjects, describe benefits to society. Please note that elements of participation
such as compensation, access to medical care, receiving study results, etc. are not considered benefits of
research participation.
[  ]  Abbreviated Submission - This information is included in an attached stand-alone protocol. Proceed to the next
question
IRB-AAAQ7746
Page 30 of 39
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Approved for use until: 02/04/2025

There is no direct benefit to the subject participating in this project. The potential benefit to others
is the information gained by determining the role of prolonged sleep restriction on energy balance
and cardio-metabolic risk profile. If successful, future work using this methodology will increase our
understanding of how sleep affects energy expenditure, food intake behaviors, and CVD health
markers. The research findings will direct future human mechanistic and clinical translational
studies concerning the role of sleep in the development of obesity.  This intervention will provide
information that will guide public health recommendations in the lifestyle management of chronic
diseases, including CVD, diabetes, obesity, and Alzheimer's disease. 
  
Alternatives:
If this research involves an intervention that presents greater than minimal risk to participants, describe available
alternative interventions and provide data to support their efficacy and/or availability. Note, participants always
have the option not to participate in research.
[  ]  Abbreviated Submission - This information is included in an attached stand-alone protocol. Proceed to the next
question
 Participants may choose not to take part in this research study.
  
Data and Safety Monitoring:
Describe how data and safety will be monitored locally and, if this is a multi-center study, how data and safety
will be monitored across sites as well.
[  ]  Abbreviated Submission - This information is included in an attached stand-alone protocol. Proceed to the next
question
All data will be kept on file coded (de-identified) with a study number and without any specific
identifying personal health information. Study data will be stored on password protected, encrypted
end-point devices. All paper files will be stored in locked cabinets in the Dr. St-Onge’s office. All
specimen samples will have unique code assigned to it that cannot be associated with the subject.
Imaging data will be stored (de-identified) in a secure computer database that is protected by
firewalls and passwords. MRI data will be transferred to the New York Image Reading Center via
secure servers. Only personnel immediately involved in the study will have access to study files
and documents. 
 
 
Unless otherwise noted, the information entered in this section should reflect the  number of subjects enrolled or
accrued under the purview of Columbia researchers, whether at Columbia or elsewhere.
Target enrollment:
250
Number enrolled to date:
188
Number enrolled since the last renewal or, if this is the first renewal, since the initial approval:
0
All scans will be reviewed by a Radiologist and any incidental findings will be disclosed to the
participant.
Subjects
IRB-AAAQ7746
Page 31 of 39
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Approved for use until: 02/04/2025

Number anticipated to be enrolled in the next approval period:
0
Does this study involve screening/assessment procedures to determine subject eligibility?
Yes
Target accrual:
79
Number accrued to date:
45
Number accrued since the last renewal or, if this is the first renewal, since the initial approval:
0
Number anticipated to be accrued in the next approval period:
0
Of the number of subjects enrolled, or the number accrued for interventional studies with a screening process:
How many remain on the study?
0
How many are off study?
45
How many completed the study?
36
Have any withdrawn of their own initiative?
Yes
How many?
5
Please explain:
Participant 203 completed phase 1, but withdrew before returning for phase 2 due to the development of an
unspecified medical circumstance, unrelated to the study/intervention.
Participants 206 and 208 both withdrew from the study prior to starting phase 2, due to limited availability.
Participants 212 and 214 elected not to return for Phase 2 due to the COVID-19 pandemic.
Have any been removed by PI?
Yes
How many?
4
Please explain:
Participant 102 completed phase 1, but failed to qualify for phase 2 on three separate occasions.
Participant 111 completed phase 1, and returned for phase 2, but was discontinued after 2 consecutive weeks
of non-adherence to the intervention.
Participant 209 was disqualified at the second follow-up visit of phase 1, due to non-adherence to the
intervention.
Participant 252 was disqualified at the third follow-up visit of Phase 1 due to non-adherence to the intervention.
Have any been lost to follow-up?
No
Have any died while on study?
No
Have any subject complaints been received?
No
Is this a multi-center study?
No
Does this study have one or more components that apply to a subset of the overall study population (e.g. Phase
IRB-AAAQ7746
Page 32 of 39
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Approved for use until: 02/04/2025

1/2, sub-studies)?
No
Of the number enrolled, or the number accrued for interventional studies with a screening process, indicate:
Population Gender
Population Age
Population Race
Population Ethnicity
Vulnerable Populations as per 45 CFR 46:
Will children/minors be enrolled
No
Will pregnant women/fetuses/neonates be targeted for enrollment?
No
Will prisoners be targeted for enrollment?
No
Other Vulnerable Populations:
[  ]Individuals lacking capacity to provide consent
[x]CU/NYPH Employees/Residents/Fellows/Interns/Students
Please ensure that a plan for avoiding elements of coercion or undue influence of these populations is
addressed on the Informed Consent page.
[  ]Economically disadvantaged
[  ]Educationally disadvantaged
[  ]Non-English speaking
[  ]Other Vulnerable populations
[  ]None of the Populations listed above will be targeted for Enrollment
Subject Population Justification:
Two hundred fifty men and pre-menopausal women, age 20-40 y and 55-75 y, BMI 25-35 kg/m2, or with BMI 20-24.9
kg/m2 who have at least one parent who has ever had a BMI >27 kg/m2, will be recruited from the New York City area
(target accrual: n=79). These individuals are considered at risk of obesity, making this study group relevant for obesity
prevention efforts.  Participants who will be recruited to participate in this study will habitually sleep 7-9 h/night, will be free
of any current and past sleep and psychiatric disorders, including eating disorders (ex. anorexia, bulimia, night eating
syndrome), and will not have diabetes or CVD, and have normal scores on all screening questionnaires. Participants with
resistant hypertension will be excluded.
Does this study involve compensation or reimbursement to subjects?
Females
Males
Non Specific
49%
51%
0%
0-7
8-17
18-65
>65
Non Specific
0%
0%
96%
4%
0%
American
Indian/Alaskan
Native
Asian
Native Hawaiian
or Other Pacific
Islander
Black or African
American
White
More than One
Race
Non-Specific
2%
9%
0%
20%
47%
7%
15%
Hispanic or Latino
Not Hispanic or Latino
Non-Specific
29%
71%
0%
IRB-AAAQ7746
Page 33 of 39
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Approved for use until: 02/04/2025

Yes
Describe and justify reimbursement/compensation:
subject compensation of $2000 (older adults) or $2400 (younger adults) will be provided
Are subjects eligible for compensation of $600 or more in a calendar year?
Yes
Subjects qualifying for compensation of $600 or more in a calendar year will need to complete a W9 form
and provide their social security number for IRS reporting purposes. If your study includes more than $600
in compensation in a calendar year, the following should be added to the consent document: According to
IRS regulations, payments totaling more than $600 in a calendar year will be reported to the Internal
Revenue Service (IRS).
 
 
 
 
 
 
 
 
Attached Attestation
Principal Investigator
Date Created
Marie Pierre St Onge (ms2554)
10/11/2023
Attached HIPAA Forms
Number
Type
Title
Status
AAAN3095
A
NIH sleep restriction
Approve
Attached Consent Forms
Number
Copied From
Form Type
Title
Active/InActive
Initiator
AACR3450
AACR3450
Consent
NIH Sleep Restriction
Active
Marie Pierre St Onge
(ms2554)
AACR3500
AACR3500
Consent
NIH Sleep Restriction
Inactive
Marie Pierre St Onge
(ms2554)
Documents
Archived
Document
Identifier
Document Type
File Name
Active
Stamped
Date Attached
Created By
No
DSMP
Data Safety
Monitoring Plan
Data_Safety_and
_Monitoring_Plan
.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
MRI Findings
Level 1 to MD
Email/Communic
ation/Message
MRI Findings
Level 1 to MD.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
MRI Findings
Level 1
Email/Communic
ation/Message
MRI Findings
Level 1.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
MRI Findings
Level 2 to MD
Email/Communic
ation/Message
MRI Findings
Level 2 to MD.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
MRI Findings
Level 2
Email/Communic
ation/Message
MRI Findings
Level 2.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
IRB-AAAQ7746
Page 34 of 39
 ( Y9M0 )
Approved for use until: 02/04/2025

Archived
Document
Identifier
Document Type
File Name
Active
Stamped
Date Attached
Created By
No
MRI Findings
Level 3 to MD
Email/Communic
ation/Message
MRI Findings
Level 3 to MD.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
MRI Findings
Level 3
Email/Communic
ation/Message
MRI Findings
Level 3.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
MRI Findings
Level 4 to MD
Email/Communic
ation/Message
MRI Findings
Level 4 to MD.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
MRI Findings
Level 4
Email/Communic
ation/Message
MRI Findings
Level 4.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
Administrative
Supplement
protocol
Funding/Grant
Application/Subc
ontract
St-Onge
Administrative
Supplement
Complete.docx
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
St-Onge PA-13-
302 FINAL
Funding/Grant
Application/Subc
ontract
St-Onge PA-13-
302 FINAL.pdf
Y
No
06/09/2016
Marie Pierre St
Onge (ms2554)
No
Actigraph Monitor
Manual
Investigator
Brochure/Packag
e Insert/Device
Manual
Actiwatch
Manual.pdf
Y
No
09/06/2016
Theresa Pizinger
(tmp2125)
No
Material Transfer
Agreement
Material Transfer
Agreement
MTA-
Out_Request_Fo
rm.pdf
Y
No
06/09/2016
Theresa Pizinger
(tmp2125)
No
PSQI validation
manuscript
Other
Buysse 1988
PSQI validity.pdf
Y
No
05/15/2017
Marie Pierre St
Onge (ms2554)
No
CITI Training
Certificate, Jeane
Cadiou
Other
CITI Training
Certificate,
Jeanne
Cadiou.pdf
N
No
05/09/2017
Ismel Salazar
(is2527)
No
PVT Screenshots Other
PVT
Screenshots.pdf
Y
No
01/19/2017
Ismel Salazar
(is2527)
No
HIPAA Fax cover Privacy and
Security
Agreement
Facsimile HIPAA
Compliant for
MRI letters.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
NIH Progress
Report, Year 1
Progress Report
Year 1
Accomplishments
.pdf
N
No
05/09/2017
Ismel Salazar
(is2527)
No
Year 3 Progress
report
Progress Report
Year 3 Progress
report.docx
N
No
03/05/2020
Justin Cochran
(jc5392)
No
Y3 Progress
report
Progress Report
Year 3 Progress
report.pdf
N
No
04/19/2019
Marie Pierre St
Onge (ms2554)
No
Year 5 Progress
Report
Progress Report
Year 5 Progress
report.docx
Y
No
01/25/2022
Mehreen Bhatti
(mzb2107)
No
advertisement
Recruitment
Material
Advertisement
craigslist.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
Flyer, Men
Recruitment
Material
NIH - Flyer, Men
(Contact
Ismel).pdf
Y
No
10/19/2016
Ismel Salazar
(is2527)
No
Flyer,
Men+Women
Recruitment
Material
NIH - Flyer,
Men+Women
(Contact
Ismel).pdf
Y
No
10/19/2016
Ismel Salazar
(is2527)
No
NIH Flyer,
Younger adults
(Contact
Mehreen)
Recruitment
Material
NIH - Flyer,
Men+Women
(Contact
Mehreen).pdf
Y
No
01/17/2019
Corinne Grady
(cg3048)
No
NIH Flyer, Older
adults (Contact
Mehreen)
Recruitment
Material
NIH - Flyer,  + ,
55-75 y-o
(Contact
Mehreen).pdf
Y
No
01/17/2019
Corinne Grady
(cg3048)
No
NIH - Flyer,  + ,
55-75 y-o
(Contact team
gmail)
Recruitment
Material
NIH - Flyer,  + ,
55-75 y-o
(Contact team
gmail).pdf
Y
No
08/31/2018
Ismel Salazar
(is2527)
No
Print
Advertisement,
Men
Recruitment
Material
NIH
Advertisement
craigslist, Men
(Contact
Ismel).pdf
Y
No
10/19/2016
Ismel Salazar
(is2527)
No
Print
Advertisement,
Men+Women
Recruitment
Material
NIH
Advertisement
craigslist,
Men+Women
(Contact
Ismel).pdf
Y
No
10/19/2016
Ismel Salazar
(is2527)
IRB-AAAQ7746
Page 35 of 39
 ( Y9M0 )
Approved for use until: 02/04/2025

Archived
Document
Identifier
Document Type
File Name
Active
Stamped
Date Attached
Created By
No
NIH
Advertisement
craigslist,
younger adults
Recruitment
Material
NIH
Advertisement
craigslist,
Men+Women
(Contact
Mehreen).pdf
Y
No
01/09/2019
Corinne Grady
(cg3048)
No
NIH
Advertisement
craigslist, older
adults
Recruitment
Material
NIH
Advertisement
craigslist,
Men+Women
Older Adults
(Contact
Mehreen).pdf
Y
No
01/09/2019
Corinne Grady
(cg3048)
No
Print ad Younger
adults
Recruitment
Material
NIH
Advertisement
craigslist,
Younger
adults.pdf
Y
No
10/04/2018
Marie Pierre St
Onge (ms2554)
No
Flyer older adults Recruitment
Material
NIH Flyer Older
adults.pdf
Y
No
10/11/2018
Marie Pierre St
Onge (ms2554)
No
Flyer younger
adults
Recruitment
Material
NIH-Flyer
Younger
adults.pdf
Y
No
10/11/2018
Marie Pierre St
Onge (ms2554)
No
Beck Depression
Inventory II
Study
Material/Instrume
nt
BDI-II
questionnaire.pdf
Y
No
01/20/2017
Marie Pierre St
Onge (ms2554)
No
berlin
questionnaire
Study
Material/Instrume
nt
Berlin
Questionnaire
C2000.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
Borg scale
Study
Material/Instrume
nt
Borg Scale.pdf
N
No
03/29/2017
Marie Pierre St
Onge (ms2554)
No
Caffeine
Consumption
Questionnaire
Study
Material/Instrume
nt
Caffeine
Consumption
Questionnaire.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
EPWORTH
SLEEPINESS
SCALE
Study
Material/Instrume
nt
EPWORTH
SLEEPINESS
SCALE.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
Basic Screening
form
Study
Material/Instrume
nt
Form 1 Basic
Screening
Form.doc
N
No
04/13/2016
Theresa Pizinger
(tmp2125)
No
Health History
Questionnaire
Study
Material/Instrume
nt
Form 10 updated
Medical History
Questionnaire.pdf
Y
No
09/29/2016
Theresa Pizinger
(tmp2125)
No
ModRey
Study
Material/Instrume
nt
Hale 2018
ModRey.pdf
Y
No
08/29/2018
Marie Pierre St
Onge (ms2554)
No
Medication Form
Study
Material/Instrume
nt
Medication
Form.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
MoCA
Study
Material/Instrume
nt
MoCA-Test-
English_7_1.pdf
Y
No
11/11/2016
Ismel Salazar
(is2527)
No
ModRey,
Alternate
Study
Material/Instrume
nt
ModRey -
Alternate
Form.pdf
Y
No
01/09/2019
Corinne Grady
(cg3048)
No
ModRey, Scoring Study
Material/Instrume
nt
ModRey -
Scoring
Sheet.pdf
Y
No
01/09/2019
Corinne Grady
(cg3048)
No
ModRey,
Standard
Study
Material/Instrume
nt
ModRey -
Standard
Form.pdf
Y
No
01/09/2019
Corinne Grady
(cg3048)
No
ModRey Form A
Study
Material/Instrume
nt
ModRey2 - Form
A.doc
Y
No
08/30/2018
Marie Pierre St
Onge (ms2554)
No
ModRey Form B
Study
Material/Instrume
nt
ModRey2 - Form
B.doc
Y
No
08/30/2018
Marie Pierre St
Onge (ms2554)
No
ModRey Form C
Study
Material/Instrume
nt
ModRey2 - Form
C.docx
Y
No
08/30/2018
Marie Pierre St
Onge (ms2554)
No
ModRey Form D
Study
Material/Instrume
nt
ModRey2 - Form
D.doc
Y
No
08/30/2018
Marie Pierre St
Onge (ms2554)
IRB-AAAQ7746
Page 36 of 39
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Archived
Document
Identifier
Document Type
File Name
Active
Stamped
Date Attached
Created By
No
morning/evening
ness
questionnaire
Study
Material/Instrume
nt
Morningness and
Eveningness in
Human Circadian
Rhythms.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
Anthropometrics
Sheet
Study
Material/Instrume
nt
NIH -
Anthropometrics
v2.pdf
N
No
05/15/2017
Ismel Salazar
(is2527)
No
Anthropometrics
Sheet
Study
Material/Instrume
nt
NIH -
Anthropometrics
v3.pdf
Y
No
07/28/2017
Ismel Salazar
(is2527)
No
Anthropometrics
Sheet
Study
Material/Instrume
nt
NIH -
Anthropometrics.
pdf
N
No
01/14/2017
Ismel Salazar
(is2527)
No
Basic Screening
Form v2
Study
Material/Instrume
nt
NIH - Basic
Screening Form
2019.pdf
Y
No
03/28/2019
Corinne Grady
(cg3048)
No
Basic Screening
Form
Study
Material/Instrume
nt
NIH - Basic
Screening
Form.pdf
Y
No
01/14/2017
Ismel Salazar
(is2527)
No
Borg Scale
Study
Material/Instrume
nt
NIH - Borg Scale
v2.pdf
Y
No
05/15/2017
Ismel Salazar
(is2527)
No
Demographics
Form
Study
Material/Instrume
nt
NIH -
Demographics
Form v2.pdf
N
No
05/09/2017
Ismel Salazar
(is2527)
No
Demographics
Form
Study
Material/Instrume
nt
NIH -
Demographics
Form v3.pdf
Y
No
07/28/2017
Ismel Salazar
(is2527)
No
Eligibility
Checklist v2
Study
Material/Instrume
nt
NIH - Eligibility
Checklist
2019.pdf
Y
No
03/28/2019
Corinne Grady
(cg3048)
No
Eligibility
Checklist
Study
Material/Instrume
nt
NIH - Eligibility
Checklist.pdf
Y
No
01/14/2017
Ismel Salazar
(is2527)
No
fMRI rating scale
Study
Material/Instrume
nt
NIH - fMRI rating
scale.pdf
Y
No
03/29/2017
Marie Pierre St
Onge (ms2554)
No
Food diary
Study
Material/Instrume
nt
NIH - Food
Diary.pdf
Y
No
03/31/2017
Marie Pierre St
Onge (ms2554)
No
Sleep Diary 2
Study
Material/Instrume
nt
NIH - Sleep Diary
2017-01-13.pdf
N
No
01/14/2017
Ismel Salazar
(is2527)
No
Sleep Diary
Study
Material/Instrume
nt
NIH - Sleep Diary
v3.pdf
Y
No
05/12/2017
Ismel Salazar
(is2527)
No
Stanford
Sleepiness Scale
Study
Material/Instrume
nt
NIH - Stanford
Sleepiness
Scale.pdf
Y
No
12/21/2016
Ismel Salazar
(is2527)
No
VAS scale
Study
Material/Instrume
nt
NIH Form 6
Visual Analog
Scale.pdf
Y
No
09/29/2016
Theresa Pizinger
(tmp2125)
No
Pilot
Questionnaire
Study
Material/Instrume
nt
Pilot
Questionnaire.pdf
Y
No
05/09/2017
Ismel Salazar
(is2527)
No
PSQI
Study
Material/Instrume
nt
PSQI .pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
SBNS AE form
Study
Material/Instrume
nt
SBNS AE
form.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
SF-36 Health
Survey
Study
Material/Instrume
nt
SF-36 Health
Survey.pdf
Y
No
04/13/2016
Theresa Pizinger
(tmp2125)
No
sleep diary
Study
Material/Instrume
nt
Sleep Diary.pdf
N
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
sleep disorders
questionnaire
Study
Material/Instrume
nt
Sleep Disorders
Questionnaire.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
Sleep
Prescription Form
Study
Material/Instrume
nt
SleepRx v2.pdf
Y
No
05/09/2017
Ismel Salazar
(is2527)
IRB-AAAQ7746
Page 37 of 39
 ( Y9M0 )
Approved for use until: 02/04/2025

 
 
Archived
Document
Identifier
Document Type
File Name
Active
Stamped
Date Attached
Created By
No
Stress
questionnaires
Study
Material/Instrume
nt
Stress
measures.pdf
Y
No
08/17/2018
Marie Pierre St
Onge (ms2554)
No
3 factor eating
questionnaire
Study
Material/Instrume
nt
THREE-FACTOR
EATING
QUESTIONNAIR
E.pdf
Y
No
04/12/2016
Theresa Pizinger
(tmp2125)
No
Updated Exit
Form
Study
Material/Instrume
nt (tracked)
Form 14 Exit
Form UPDATED
NIH .pdf
Y
No
06/09/2016
Theresa Pizinger
(tmp2125)
No
Basic Screening
Form Track
Changes
Study
Material/Instrume
nt (tracked)
NIH - Basic
Screening Form
2019 Track
Changes.doc
Y
No
04/25/2019
Corinne Grady
(cg3048)
No
Eligibility
Checklist Track
Changes
Study
Material/Instrume
nt (tracked)
NIH - Eligibility
Checklist 2019
Track
Changes.doc
Y
No
04/25/2019
Corinne Grady
(cg3048)
Tasks
Section
Task
Required for
submission
Completed
Created By
Date Created
Renewal
Information
Please note, for all
future
submissions, all
personnel changes
must be detailed
and specifically
state who is being
removed or added.
Stating 'personnel
have been
removed' is not
sufficient.
Yes
No
Adrian Reyes
Gloss (ar4370)
2024-01-31
11:37:02.0
Personnel
You made
changes to the
study personnel,
however, you
indicated in the
Renewal
Information that no
modifications are
included in this
renewal. Please
note that changes
in personnel are
considered
modifications to
the study and need
to be listed as
modifications.
Yes
Yes
Pilar Borvice
(pb2913)
2024-01-12
14:15:56.0
IRB-AAAQ7746
Page 38 of 39
 ( Y9M0 )
Approved for use until: 02/04/2025

Section
Task
Required for
submission
Completed
Created By
Date Created
Subjects
The enrollment
numbers were not
updated since the
last renewal. For
example, last year
and this year, the
total enrolled is the
same (188). In
addition, the
number of subjects
enrolled since the
previous renewal is
also the same (5).
Please review this
section and revise
all the enrollment
and accrual
numbers.
Yes
Yes
Pilar Borvice
(pb2913)
2024-01-12
14:23:46.0
Documents
Please remove all
documents that are
inactive, tracked
versions, no longer
in use or that have
been superseded
by newer versions.
As the enrollment
status is listed as
closed/data
analysis, this
includes all
consent forms,
recruitment
materials, or any
other subject
facing materials.
Previous versions
of these
documents will
remain in RASCAL
with the
submission under
which they were
approved.
Yes
No
Adrian Reyes
Gloss (ar4370)
2024-01-31
11:40:06.0
IRB-AAAQ7746
Page 39 of 39
 ( Y9M0 )
Approved for use until: 02/04/2025