Home Sleep and Circadian Phase: Mediators of Diabetes Risk
Conditions: Sleep Deprivation, Diabetes, Circadian Dysregulation
Sponsor: Northwestern University

Version #:18 
Version Date:  05/24/2018 
Page 1 of 11 
PROTOCOL: 
NCT# 01786564 
 
IRB STU#: 00204605 
Title: Home sleep and circadian phase: mediators of racial disparities in diabetes risk 
 
PRINCIPAL INVESTIGATOR: 
Kristen Knutson 
Department of Neurology 
312-503-1526 
kristen.knutson@northwestern.edu 
 
VERSION NUMBER: Version 18 
VERSION DATE: May 24, 2018 
 
OBJECTIVES:  
The goal of this research project is to see if deficient sleep and/or circadian disruption are partly 
responsible for the increased risk of diabetes among African Americans by examining sleep in 
the home and measuring disease risk in the laboratory. 
 
Specific Aim 1: Disparities in sleep and circadian timing at home 
Hypothesis 1: African-Americans will have shorter habitual sleep duration (wrist actigraphy), 
less slow-wave sleep (polysomnography [PSG]) at home, and as our pilot data suggest, 
sleep at later clock times, have a later circadian phase (dim light melatonin onset [DLMO]), 
and thus sleep at a different circadian phase (DLMO-midpoint of sleep interval) than non-
Hispanic whites. 
 
 
Specific Aim 2: Association between sleep/circadian measures and diabetes risk   
Hypothesis 2: Deficient sleep duration and quality (shorter habitual sleep time, less slow-
wave sleep [SWS], lower slow-wave activity [SWA]), a later DLMO and sleeping at a 
different circadian phase (DLMO-midpoint of sleep interval) will be associated with greater 
diabetes risk (indicated by lower SI). 
 
 
Hypothesis 3: African-Americans will have greater risk of diabetes (indicated by lower 
disposition index) than non-Hispanic whites and this difference will be partially and 
significantly mediated by differences in sleep and circadian measures (identified by Specific 
Aim 2). 
 
STUDY DESIGN 
INCLUSION AND EXCLUSION CRITERIA: 
This study will recruit African Americans (AA) and non-Hispanic whites (WH) with equal 
numbers of men and women in each group completing the entire study. Ages will be 21-50 
years and body mass indices (BMI) will be <40 kg/m2.  To ensure equal age and BMI 
distribution, we will recruit stratified by age (21-35 or 36-50 years) and BMI (<30 or 30-39 kg/m2) 
within each racial group.   
Each subject will undergo an overnight screening that will include a clinical examination, 
and routine laboratory tests (including CBC/hematocrit).  An overnight PSG will be performed to 
rule out sleep disorders, including moderate to severe sleep-disordered breathing (apnea-
hypopnea index>15/hour).  We will also perform an oral glucose tolerance test (see details 
below).  Additional inclusion criteria include no major illness and no history of psychiatric, 

Version #:18 
Version Date:  05/24/2018 
Page 2 of 11 
endocrine, cardiac or sleep disorders, and premenopausal women.  Those with dyslipidemia 
and hypertension will be included if these conditions are controlled by a stable treatment, such 
as lipid-lowering or antihypertensive medications (except beta-blockers).   
Exclusion criteria include: persons with diabetes, diagnosed sleep disorders, history of 
cardiovascular event or disease (excluding controlled hypertension), major psychiatric disorder 
or other major illness.  Persons taking medications, including but not limited to antidepressants 
and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as 
mentioned above), will be excluded.  Also persons regularly taking medication that affects 
melatonin such as beta blockers and exogenous melatonin will be excluded.  We will also 
exclude anyone who tests positive for common drugs of abuse, people with color blindness and 
people who have had Lasik eye surgery, or work night shifts in the month prior to study.  
Participants who travel across time zones will be studied only after they have remained in the 
Central Time Zone (or Indiana) for one month prior to the study. Adults unable to consent, 
individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners 
are also excluded. 
 
Subjects who remain eligible after screening will then be scheduled for a one week in-
home assessment, which will be followed by an 18-hour laboratory study.  The subjects will be 
given a brief sleep diary at screening to complete prior to the naturalistic session if they are 
eligible for the study.  This brief diary asks for bed times and wake times, which is used to set 
up the equipment for the at-home saliva sampling. 
 
 
STUDY-WIDE NUMBER OF PARTICIPANTS: 
The study was previously conducted at University of Chicago, recruitment, enrollment, and 
study procedures occurred from 2012 to November 2016. In that time, the study consented 176 
subjects, screened 107, and had 53 subjects complete the study. Now Northwestern University 
will be the only site where recruitment and participation in the study will occur. See “Number of 
Local Participants” for total study numbers.  
 
 
STUDY TIMELINES: 
Each subject is expected to participate for a total of about 12 days: 1 overnight screening visit, 
10 days in naturalistic session, followed by the overnight in the laboratory session. Overall 
duration of this protocol from signing consent form to completing of the entire study will range 
from 4-12 weeks.  Recruitment will be completed by 5/31/2018 and primary data analysis by 
5/31/2019. 
 
STUDY ENDPOINTS: 
The goal of this research project is to see if deficient sleep and/or circadian disruption are partly 
responsible for the increased risk of diabetes among African Americans by examining sleep in 
the home and measuring disease risk in the laboratory. 
 
PROCEDURES INVOLVED: 
In-home assessment:  The in-home assessment will last approximately 10 days during which 
they will continuously wear a waterproof wrist actigraphy monitor and complete sleep diaries to 
estimate habitual sleep duration and timing (Figure 1).  On the Days 1 and 2 subjects will be 
instructed to abstain from caffeine, alcohol and NSAIDS.  On Day 2 beginning in the early 
evening, the subjects will be instructed to collect saliva samples (details below) to estimate 
circadian phase (DLMO).  Participants will be asked to refrain from taking NSAIDs during these 
two days during the in-home assessment because they suppress melatonin levels.  A list of 
NSAIDs by both generic and commercial names will be provided along with a sample of Tylenol 

Version #:18 
Version Date:  05/24/2018 
Page 3 of 11 
to use if needed, as long as the study physician approves Tylenol use for the subject.  On one 
of the nights after the DLMO collection (between Days 5 through 9), a mixed gender research 
team will visit the participant’s home to pick up the saliva samples and to set up one night of 
unattended in-home PSG recording.  A sound pressure meter and light sensor (Actiwatch-2) will 
be placed in the participant’s bedroom the night of the PSG recording to measure sound and 
light levels during the sleep period.  On Days 7-9, they will also complete a 3-day food diary that 
asks for both the amount and types of food eaten and time of meals and snacks.   
 
 
During this session, participants will also complete questionnaires that assess subjective sleep 
and sleepiness (Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Sleep Habits 
Questionnaire, Sleep Environment, Sleep Recording Experience), circadian preference (Horne-
Ostberg, Munich Chronotype Questionnaire), physical activity (International Physical Activity 
Questionnaire – Short Version), health factors (self-rated health 1, Physical Health 
Questionnaire 2., caffeine, alcohol and tobacco use) sociodemographic factors and psychosocial 
measures.  Sociodemographic information will include employment status, education, work 
hours, household size, number of children, the presence of a bed partner and the MacArthur 
Socioeconomic Questionnaire.  We will also administer several psychosocial questionnaires, 
including Cohen’s Perceived Stress Scale 3, chronic stress questionnaire 4, three-item 
Loneliness Scale 5, Perceived Racism Scale 6, Interpersonal Support Evaluation List 7, the 
Center for Epidemiologic Studies - Depression Scale 8, and the short version of the Spielberger 
State-Trait Anxiety Inventory 9. Questionnaire responses will be entered into the password-
protected REDCap database and saved according to confidential study ID number.  
 
Laboratory Session:  Within one week of the in-home assessment, participants will spend 
approximately 21 hours in the sleep research laboratory (W4) or Clinical Research Center (W5) 
to obtain detailed characteristics of diabetes risk.  They will be admitted to the laboratory by 
17:00.  Saliva samples will be collected every 30 minutes beginning 4.5 hours before bedtime, 
at 17:30, up to bedtime at 22:00 (total of 10 samples) for cortisol and melatonin. Time in bed in 
the laboratory will be from 22:00 to 8:00.  PSG will be recorded if the at-home PSG is invalid.  
Actigraphy will be recorded through the session. Urine samples will be collected from 6:00 PM 
onwards until the first morning void the next morning, to test for secretion of 6-
sulfatoxymelatonin (aMT6-s), a principal metabolite of melatonin excreted in urine and has been 
associated with glucose metabolism 10. ELISA readouts for aMT6-s are calculated after 
adjusting for creatinine levels in each sample.  In the morning after the first night, bioimpedance 
will be measured to estimate body fat percentage.  Then, a 5-hour frequently-sampled oral 
glucose tolerance test (OGTT) will be performed.  Electrocardiogram (ECG) will be measured 
continuously.  Blood pressure (BP) will be recorded starting at 20:00 on the first day until 2:00, 
Figure 1. Full Protocol
Sleep
fsOGTT
Admit
22
02
06
10
14
Clock Time
Discharge
Blood Pressure Monitoring
Bioimpedance
ECG
Saliva Sampling
Naturalistic Session
• 1 week wrist actigraphy
• 3-day food diary 
• 1 day of saliva sampling (DLMO)
• 1 in-home Full PSG recording
• Questionnaires
18
Laboratory Session

Version #:18 
Version Date:  05/24/2018 
Page 4 of 11 
which will allow for 6 hours of undisturbed sleep. Participants will be given lunch after 
completion of the OGTT and then discharged. 
 
Measures of Glucose Metabolism 
 
During the laboratory session, a 75 gm frequently-sampled oral glucose tolerance test 
(OGTT) will be performed.  At time 0, 75 g of dextrose will be administered orally, and blood 
samples will be collected for the measurement of glucose, insulin, C-peptide concentrations at –
10, 0, 10, 20, 30, 60, 90, 120, 150, 180, 240 and 300 min after glucose ingestion. Insulin 
secretion rates (ISR) will be calculated by deconvolution of C-peptide levels 11. In addition to 
fasting glucose, insulin, C-peptide and ISR levels, the areas under the curve (AUCs) will be 
calculated using the trapezoid method. Homeostasis model assessment (HOMA) measures of 
beta cell function and insulin resistance will be calculated from fasting values and the 
insulinogenic-index will be derived. Indexes of beta-cell function and insulin sensitivity will be 
estimated using the oral minimal model. Indexes of beta-cell function will be estimated from 
plasma glucose and C-peptide concentrations using the oral minimal model of C-peptide 
secretion and kinetics 12-14 and incorporating standardized parameters for C-peptide kinetics and 
volume of distribution 11.  Assays will be performed by validated procedures routinely used in the 
Endocrine Laboratory at the University of Chicago.  We plan to continue to use this laboratory to 
maintain consistency in assay results. 
During screening, an oral glucose tolerance test (OGTT) will be performed after an overnight 
fast to rule out the presence of diabetes.  Blood samples will be taken beginning with baseline 
samples at -15 and 0 minutes. At time 0, 75g of glucose will be administered orally over 5 
minutes. A final blood sample will then be collected at 120 minutes after ingestion. The glucose 
levels at 0 and 120 minutes will be used as diagnostic measures for diabetes.   
 
Sleep Measures 
Polysomnography (PSG) 
Sleep will be recorded in the home, during the screening session and in the laboratory 
session if necessary using digital acquisition systems (Nihon Kohden, CA). Recordings will 
include electroencephalography (EEG), electrooculography (EOG), electromyography (EMG) 
and electrocardiography (ECG) signals. In addition, oronasal airflow by thermocouples and 
nasal pressure transducer, respiratory effort from thoracic and abdominal piezo electric belts, 
and pulse oximetry will be recorded at screening. Each 30-sec epoch of recording will be scored 
as stage Wake, I, II, III or REM following standard criteria 15,16 by an experienced rater who will 
be blinded to the age, gender and race of the subject. Respiratory events, periodic limb 
movements and microarousals will be scored according to established criteria 17,18. Spectral 
analysis of EEG in the delta, theta, alpha, sigma, beta and gamma bands will be performed 
using the PRANA software (PhiTools, Strasbourg, France).   
 
Wrist Actigraphy Monitoring 
 
Sleep timing and duration will be assessed during the naturalistic and laboratory sessions 
using waterproof wrist actigraphy monitors (Actiwatch-2, Respironics/Philips).  Due to the 
unobtrusive nature of this device, habitual sleep behavior can be measured over several days.  
Dr. Knutson has extensive experience working with actigraphy data and has found a great deal 
of variability within individuals from day to day 19.  Thus, a full week of actigraphy is necessary to 
estimate habitual sleep patterns.  Participants will be asked to wear the Actiwatch continuously 
for the entire naturalistic session and during the laboratory session.  Actiwatch activity monitors 
feature digital integration, which is the most accurate measure of both movement level and 
intensity.  In order to calculate the various sleep characteristics, an estimate of bedtime and 
wake time is obtained from two sources, the Actiwatch event marker and the sleep log.  The 

Version #:18 
Version Date:  05/24/2018 
Page 5 of 11 
Actiwatch has a button on the side that the subject presses to “mark” the data.  This does not 
affect data collection but simply provides a mark in the data which can be used to set the bed 
time and wake time.  The subject is also asked to complete a sleep log each morning, and this 
provides an additional method to determine bedtime and wake time.  The combination of these 
two collection methods provides the most accurate determination of bedtime and wake time.  
Our primary measure of habitual sleep will be nocturnal sleep duration as well as the timing of 
sleep, however, we will also examine indicators of sleep quality (sleep efficiency, sleep 
fragmentation) and napping behavior. 
 
Circadian Measures 
 
As described above, we will collect saliva samples in the home to estimate circadian phase 
from the DLMO, and this will be our primary measure of circadian phase.  During a start-up 
appointment, subjects will receive the Actiwatch, questionnaires, and at-home saliva collection 
kit and given extensive verbal and written instructions about the procedures.  On the day of the 
planned saliva collection, a research assistant will call the participant at a prearranged time and 
remind them of the instructions for the at-home saliva collection.  Collection will begin 6 hours 
prior to bedtime.  The at-home saliva collection kit comes in a black messenger bag and 
consists of: a step-by-step checklist (with staff phone number), track cap bottle (with microchip 
in lid that records opening, MEMS, Aardex) containing 13 cotton inserts for saliva collection, 13 
empty salivettes, small test tube rack, timer (PDA) with preprogrammed alarms, label dispenser 
(pre-labeled to avoid incorrect sample labeling), soft toothbrush (to avoid toothpaste 
contamination), insulated travel bag for frozen samples, 8 Tylenol pills (to avoid inadvertent use 
of NSAIDs), photosensor to be worn around the neck on top of clothing (Actiwatch Spectrum, 
wrist worn photosensors are easily covered by sleeves), and sunglasses (Noir medicals; frame 
style 21 or frame style 30 fitted with a filter #23) worn through the evening of the saliva sampling 
session until bedtime (to reduce light intensity received by the eyes while allowing for 
comfortable vision). 
 
The checklist advises participants to close blinds and/or curtains to avoid outdoor light, and 
dim lights to a practical level (including bathroom lights).  Participants are prompted by 
preprogrammed timer and checklist to briefly brush teeth with water 10 minutes before the first 
sample and before any sample if have eaten since the last sample, and at sample time open the 
track cap bottle, select a cotton insert, roll around in mouth for a few minutes, close track cap 
bottle, spit cotton insert into salivette, attach label from label dispenser and place salivette in 
test tube rack in freezer.  At the end of the checklist, subjects remove their light medallion and 
go to bed.  On the following night the research team that sets up the at-home PSG, will pack all 
frozen samples in the insulated travel bag and transport samples to the lab. 
 
On arrival in the laboratory the saliva samples are thawed, centrifuged and then refrozen 
and shipped for RIA assay by SolidPhase (Portland, ME).  The sensitivity of the assay is 0.7 
pg/ml, intra-assay variance (<11%) and inter-assay variance (<14%).  The results of the assay 
will be emailed to Dr. Knutson who will remove subject and condition codes and forward the 
data to Dr. Burgess.  Dr. Burgess will calculate the DLMOs and a research assistant will confirm 
the scoring before the results are unblinded.  As recommended by a consensus report Dr. 
Burgess recently coauthored 20, we will calculate the DLMO threshold as the mean of 3 low 
daytime points plus 2 times the SD of the 3 points.  Our previous study 21 showed that in 100% 
of our large sample (n=170) the DLMO occurred within the 6 hour window prior to habitual 
bedtime.  Even DLMOs of extreme night owls are captured before habitual bedtime if low 
thresholds for DLMO detection are used 22-24.  If we find that there are not enough low daytime 
points in a melatonin profile, we will follow the consensus report and use a fixed low threshold of 
3 pg/ml.  Very occasionally melatonin levels rise above and then fall below the threshold more 
than once. In this case the DLMO will be defined as when melatonin levels begin to stay above 
threshold for ≥ 2 h (e.g. 25). 

Version #:18 
Version Date:  05/24/2018 
Page 6 of 11 
 
Dr. Burgess has a lot of experience collecting and analyzing light data and can easily 
identify noncompliance (e.g. artificially stable light indicates photosensor taken off).  She has 
previously recorded ambient light levels in people’s homes 25,26 and found they are naturally 
quite low (<50 lux). Research indicates that melatonin is not significantly suppressed by light 
levels this low 27 and our pilot data supports this. In addition to the DLMO we will also examine 
the timing of habitual sleep based on actigraphy, the timing of meals and circadian preference 
based on the Horne-Osberg Morningness-Eveningness questionnaire 28. 
 
Cardiovascular and Autonomic Measurements 
 
Systolic and diastolic arterial blood pressure will be measured at 30-minute intervals from 
the non-dominant arm using ambulatory monitoring equipment (Oscar II, SunTech Medical 
Instruments). Heart rate variability will be calculated using the ECG recording from the PSG 
recording. Please note Dr. Burgess is experienced in the assessment of heart rate variability 
measures 29-34. We will also assay an inflammatory marker, high sensitively c-reactive protein 
(hsCRP), and lipids in the fasting blood samples taken during the OGTT. 
Power Analysis 
For the grant transfer, we calculated the sample size required to detect a difference between the 
whites and African Americans using the standard deviation from the already-collected data in 
this study for independent sample t tests.  I used an alpha of .05 and a beta of .80. See Table 2 
below.  Sample size estimates were also calculated to detect significant associations (p<.05) 
between two continuous variables using the same standard deviations as in table below. We will 
have 80% power to detect a change in 1000 units of DI per 1 SD of each sleep/circadian 
variable with 23 subjects and we will have 80% to detect a change in 500 units of DI per 1 SD of 
each sleep/circadian variable with 84 subjects.  Similarly, using Matsuda Index instead of DI, we 
can detect a change of 5 units per SD of each sleep/circadian variable (80% power, alpha=.05) 
with ~9 subjects and 2 units with ~40 subjects.  
 
Table 4.  Sample size required to detect differences between races. 
Outcome 
Mean Difference 
SD 
n required in each 
group 
Sleep 
 
 
 
Habitual Sleep Duration 
30 minutes 
37.26187 
25 
Habitual Sleep 
Fragmentation 
5% 
4.605201 
14 
Slow wave sleep 
30 minutes 
33.62934 
20 
REM sleep 
45 minutes 
50.03308 
20 
DLMO-Sleep Interval 
1 hour 
1.183996 
23 
Health related 
 
 
 
Matsuda Index 
3 units 
3.734893 
25 
Total DI 
1250 units 
1609.562 
27 
SBP 
12 mmHg 
14.08113 
22 
DBP 
7 mmHg 
7.93775 
7 
 
 
Data Analysis 
There are three main hypotheses that we plan to test.  In all of these analyses our primary 
outcome of interest will be the Oral Disposition Index (DIo), from the OGTT, which will be tested 
at the α = 0.05 level.  Additional metabolic risk factors will be explored as secondary outcomes 
of interest, including insulin sensitivity and glucose levels.  All secondary tests will be conducted 

Version #:18 
Version Date:  05/24/2018 
Page 7 of 11 
using a Bonferroni-corrected alpha level of α = 0.005, to reduce type I errors due to multiple 
testing.  Model assumptions will be tested with each outcome of interest and transformations of 
the dependent variables will be considered if the model residuals are not approximately 
normally distributed.  All regression models described below will be checked for fit to the data 
through examination of residuals and other regression diagnostic techniques 35.   
 
Linear regression models will be estimated to test for differences in the sleep and circadian 
measures between African Americans and whites.  Covariates for which we will adjust include 
age, sex and BMI or body fat percentage.  Secondary analysis will include examination of 
potential sociodemographic and psychosocial confounders of this association. Linear regression 
models will also be estimated to test for associations between our primary metabolic outcome, 
Disposition Index, and measures of sleep, including duration and percentage from actigraphy 
and Stage 3 and REM for PSG. Covariates for which we will adjust include age, sex, and BMI or 
body fat percentage, socioeconomic position and psychosocial factors. 
 
Confidentiality  
Study records will be kept confidential and data and records will be stored in locked cabinets in 
private offices.  Electronic data files will be stored on password-protected computers.  Data files 
and documents (with the exception of the consent form) will be stripped of identifying 
information and subjects will be identified only by a study ID code.  Only one file will have the 
name and contact information linked to the study code, and this information will be linked for the 
duration of the study (5 years).  After this time, the linked information will be destroyed. 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS: 
All adverse events, serious and non-serious, occurring during the course of the study will be 
collected, fully documented, and reported to the Northwestern University Internal Review Board 
(IRB) by the Principal Investigator, Dr. Knutson. For each adverse event, the investigator will 
provide the onset, duration, intensity and treatment required, outcome and action taken. We 
anticipate that adverse events during this study would be related to drawing blood, resulting in a 
bruise at the site of vein puncture, inflammation of the vein, and infection. All reasonable care 
will be taken to avoid these complications. In addition to adverse event reporting, the 
investigators will report a summary of the protocol findings, subject recruitment, drop-outs, and 
events to the IRB annually. The physiological studies will be conducted in the Northwestern 
CRU, and as such, will be overseen by the CRU Data Safety Monitoring Board. All data will be 
kept confidential and in a locked cabinet. Only approved study personnel will have access to 
study related documents. 
 
WITHDRAWAL OF PARTICIPANTS: 
Participants are free to choose to stop participation in the study at any time.  They will be 
explicitly told that choosing not to be in this study or to stop being in this study will not result in 
any penalty to them or loss of benefit to which they are entitled.  Specifically, the choice to 
withdraw will not negatively affect the right to any present or future medical treatment to which 
they are otherwise entitled. If participants withdraw, the procedure will immediately stop, they 
will be asked to fill out paperwork regarding monetary compensation for the completed portion 
of the study.  Compensation will be prorated on the number of visits completed as described in 
the consent form. 
  
The PI in charge of the study may decide to end participation at any time without participant 
consent. Reasons for removal may include: 1) it is in the best interest of the participants’ health, 
2) the participant is unable to follow the directions of the study, or 3) the participant no longer 
qualifies for the study, or 4) the study stops. If the PI withdraws a participant from the study, they 

Version #:18 
Version Date:  05/24/2018 
Page 8 of 11 
will always explain the reasons for doing so and will help arrange for continued care the 
participants own doctor, if needed.  
 
RISKS TO PARTICIPANTS: 
The clinical procedures involve minimal discomfort associated with venipuncture. There is also 
slight risk of inflammation of the vein or infection. However, our nurses who perform these 
procedures are highly trained and thus these risks are minimal. The amount of blood withdrawn 
is minimized to prevent significant blood loss. Baseline hematocrit will be measured in all 
subjects to ensure that this risk is not excessive.  Furthermore, a study physician will be 
available should any medical concerns arise. Participation is voluntary and participants may 
withdraw from the study at any time. 
 
There is potential risk of breach of privacy and confidentiality which will be minimized by having 
computer based data records identifiable only by a participant number. Names will not be stored 
with the participant data. Identifying information will be stored separately in a password 
protected file that will be linked to a participant number. 
 
 
POTENTIAL BENEFITS TO PARTICIPANTS: 
There is no direct benefit to the subject for participating in this study. The information gained 
from this study will help to better understand the relationship between habitual sleep behavior 
and characteristics in real-life conditions (i.e. the person’s own home) and cardiometabolic risk.  
Furthermore, this study will also determine whether differences in sleep characteristics partly 
explain differences in diabetes risk between African Americans and whites. Ultimately, future 
studies may provide novel insights into the mechanisms linking impaired or insufficient sleep 
with the risk of cardiovascular disease, obesity and diabetes. The risks are only minimal and the 
risk-to-benefit ratio is very small. 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS: 
Potential risk of breach of privacy and confidentiality will be minimized by de-identifying the data 
with participant number. Paper copy of the surveys will be stored in a locked cabinet in the 
Circadian Rhythms and Sleep Research Laboratory. Each participant will be assigned a study 
number, and the participant name and study number will be stored in REDCap, which is only 
accessible to IRB-approved study team members, and requires a unique password for each 
user.  REDCap (Research Electronic Data Capture) is a secure, web-based application for 
building and managing online data capture for research studies. Northwestern University is a 
member of the REDCap consortium. All data collected from the surveys will be de-identified and 
entered into REDCap or an excel file that is on a password protected computer and server.  
Data collected from PSG and electrocardiogram will be downloaded to a password protected 
computer in the Circadian Rhythms and Sleep Research Laboratory for analysis. After all data is 
collected and analyzed, all files containing identifying information will be destroyed. Only one file 
will have the name and contact information linked to the study code, and this information will be 
linked for the duration of the study (5 years).  After this time, the linked information will be 
destroyed. 
 
Note this protocol involves collaboration with Dr. Helen Burgess from Rush University.  Her 
expertise in assessing DLMO at home is required. She will assist with data analysis of 
melatonin to identify DLMO, but the data will all be de-identified before being shared.  This 
protocol will also be reviewed by the IRB at Rush University. 
 
CONSENT PROCESS: 

Version #:18 
Version Date:  05/24/2018 
Page 9 of 11 
Informed consent will be obtained by study team members or the investigator at the 
Northwestern University Center for Circadian and Sleep Medicine. The study procedures will be 
explained to interested persons and all questions will be answered. A copy of the signed 
consent form(s) will be given to the subject and the original document(s) will be kept in the 
research subject’s file. Study procedures will be conducted as soon as possible after consent is 
obtained. 
 
PROCESS TO DOCUMENT CONSENT IN WRITING: 
An IRB approved consent form will be signed by each participant. 
 
 
Bibliographic references  
1. 
Idler EL, Angel RJ. Self-rated health and mortality in the NHANES-I Epidemiologic 
Follow-up Study. Am J Public Health. 1990;80(4):446-452. 
2. 
Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for 
evaluating the severity of somatic symptoms. Psychosom Med. 2002;64(2):258-266. 
3. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health 
and Social Behv. 1983;24:385-396. 
4. 
Turner RJ, Wheaton B, Lloyd DA. The epidemiology of social stress. Am Sociol Rev. 
1995;60:104-125. 
5. 
Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring 
Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 
2004;26(6):655-672. 
6. 
McNeilly MD, Anderson NB, Armstead CA, et al. The perceived racism scale: a 
multidimensional assessment of the experience of white racism among African 
Americans. Ethn Dis. 1996;6(1-2):154-166. 
7. 
Cohen S, Hoberman H. Positive events and social supports as buffers of life change 
stress. Journal of Applied Social Psychology. 1983;13:99-125. 
8. 
Radloff L. The CES-D Scale:  A Self-Report Depression Scale for Research in the 
General Population. Appl Psych Meas. 1977;1(3):385-401. 
9. 
Marteau TM, Bekker H. The development of a six-item short-form of the state scale of 
the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992;31 ( Pt 
3):301-306. 
10. 
Peschke E, Muhlbauer E. New evidence for a role of melatonin in glucose regulation. 
Best Pract Res Clin Endocrinol Metab. 2010;24(5):829-841. 
11. 
Van Cauter E, Mestrez F, Sturis J, Polonsky KS. Estimation of insulin secretion rates 
from C-peptide levels: comparison of individual and standard kinetic parameters for C-
peptide clearance. Diabetes. 1992;41:368-377. 
12. 
Breda E, Cavaghan MK, Toffolo G, Polonsky KS, Cobelli C. Oral glucose tolerance test 
minimal model indexes of beta-cell function and insulin sensitivity. Diabetes. 
2001;50(1):150-158. 
13. 
Breda E, Toffolo G, Polonsky KS, Cobelli C. Insulin release in impaired glucose 
tolerance: oral minimal model predicts normal sensitivity to glucose but defective 
response times. Diabetes. 2002;51 Suppl 1:S227-233. 
14. 
Dalla Man C, Yarasheski KE, Caumo A, et al. Insulin sensitivity by oral glucose minimal 
models: validation against clamp. Am J Physiol Endocrinol Metab. 2005;289(6):E954-
959. 
15. 
Iber C, Ancoli-Israel S, Chesson AJ, Quan SF. The AASM Manual for the Scoring of 
Sleep and Associated Events: Rules, Terminology and Technical Specifications. 
Westchester, Illinois: American Academy of Sleep Medicine; 2007. 

Version #:18 
Version Date:  05/24/2018 
Page 10 of 11 
16. 
Rechtschaffen A, Kales A. A manual of standardized terminology, techniques and 
scoring system for sleep stages of human subjects. UCLA Brain Information 
Service/Brain Research Institute, Los Angeles;1968. 
17. 
EEG arousals: scoring rules and examples: a preliminary report from the Sleep 
Disorders Atlas Task Force of the American Sleep Disorders Association. Sleep. 
1992;15(2):173-184. 
18. 
Sleep-related breathing disorders in adults: recommendations for syndrome definition 
and measurement techniques in clinical research.  The Report of an American Academy 
of Sleep Medicine Task Force. Sleep. 1999;22(5):667-689. 
19. 
Knutson KL, Rathouz PJ, Yan LL, Liu K, Lauderdale DS. Intra-individual daily and yearly 
variability in actigraphically recorded sleep measures: the CARDIA study. Sleep. 
2007;30(6):793-796. 
20. 
Benloucif S, Burgess HJ, Klerman EB, et al. Measuring melatonin in humans. J Clin 
Sleep Med. 2008;4(1):66-69. 
21. 
Burgess HJ, Fogg LF. Individual differences in the amount and timing of salivary 
melatonin secretion. PLoS One. 2008;3(8):e3055. 
22. 
Mundey K, Benloucif S, Harsanyi K, Dubocovich ML, Zee PC. Phase-dependent 
treatment of delayed sleep phase syndrome with melatonin. Sleep. 2005;28(10):1271-
1278. 
23. 
Nagtegaal JE, Kerkhof GA, Smits MG, Swart ACW, Van der Meer YG. Delayed sleep 
phase syndrome: A placebo-controlled cross-over study on the effects of melatonin 
administered five hours before the individual dim light melatonin onset. J Sleep Res. 
1998;7(2):135-143. 
24. 
Wyatt JK, Stepanski EJ, Kirkby J. Circadian phase in delayed sleep phase syndrome: 
predictors and temporal stability across multiple assessments. Sleep. 2006;29(8):1075-
1080. 
25. 
Burgess HJ, Eastman CI. Early versus late bedtimes phase shift the human dim light 
melatonin rhythm despite a fixed morning lights on time. Neuroscience Letters. 
2004;356(2):115-118. 
26. 
Burgess HJ, Eastman CI. A late wake time phase delays the human dim light melatonin 
rhythm. Neuroscience Letters. 2006;395(3):191-195. 
27. 
Zeitzer JM, Dijk DJ, Kronauer R, Brown E, Czeisler C. Sensitivity of the human circadian 
pacemaker to nocturnal light: melatonin phase resetting and suppression. J Physiol. 
2000;526 Pt 3:695-702. 
28. 
Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-
eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110. 
29. 
Burgess HJ, Penev PD, Schneider R, Van Cauter E. Estimating cardiac autonomic 
activity during sleep: impedance cardiography, spectral analysis, and Poincare plots. 
Clin Neurophysiol. 2004;115(1):19-28. 
30. 
Burgess HJ, Trinder J, Kim Y. Cardiac parasympathetic nervous system activity does not 
increase in anticipation of sleep. J Sleep Res. 1996;5(2):83-89. 
31. 
Burgess HJ, Trinder J, Kim Y. Cardiac autonomic nervous system activity during 
presleep wakefulness and Stage 2 NREM sleep. Sleep Research. 1999;8:113-122. 
32. 
Burgess HJ, Trinder J, Kim Y, Luke D. Sleep and circadian influences on cardiac 
autonomic nervous system activity. Am J Physiol. 1997;273:H1-H8. 
33. 
Harris AS, Burgess HJ, Dawson D. The effects of day-time exogenous melatonin 
administration on cardiac autonomic activity. J Pineal Res. 2001;31(3):199-205. 
34. 
Holmes AL, Burgess HJ, Dawson D. Effects of sleep pressure on endogenous cardiac 
autonomic activity and body temperature. J Appl Physiol. 2002;92(6):2578-2584. 
35. 
McCullagh P, Nelder J. Generalized linear models. Monographs on statistics and applied 
probability. London: Chapman and Hall; 1989. 

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 1 of 10
Version Date: 03/08/2018
Title of Research Study: Home sleep and circadian phase: mediators of diabetes risk 
Investigator:  Kristen L. Knutson, PhD
Phone: (312) 503-1526
Supported By: This research is supported by the NIH, Northwestern University, and Rush 
University.
Why am I being asked to take part in this research study?
We are asking you to take part in this research study because you are a healthy adult between 
the ages of 21-50.
What should I know about a research study?

Someone will explain this research study to you.

Whether or not you take part is up to you.

You can choose not to take part.

You can agree to take part and later change your mind.

Your decision will not be held against you.

You can ask all the questions you want before you decide.
Why is this research being done?
The purpose of this study is to determine if deficient sleep and/or disruption with the body’s 
internal clock (“circadian rhythms”) are associated with diabetes risk. This study is being done to 
look at the possible relationships between sleep and risk of diabetes by examining sleep in the 
home and diabetes risk in the laboratory.  
How long will the research last and what will I need to do?
We expect that you will be in this research study for two-four weeks and require 2 overnight 
visits to the Hospital Clinical Research Unit.
You will participate in an overnight screening session to determine if you are eligible to 
participate in the study. We will conduct a sleep study with electrodes placed on your head and 
legs, and sensors by your nose, chest, and belly.  The following morning you will also have an 
“oral glucose tolerance test,” which measures how your body uses sugar. An IV will be inserted 
into your arm and blood will be sampled before and after drinking a sugary solution, totaling less 
than 1 teaspoon of blood. You will also have a medical examination, a urine drug screening, and 
a blood test. 
You will then undergo the 10 day in-home assessment, which will be scheduled as soon as 
possible after the screening session. During  this assessment you will wear a waterproof wrist 
activity monitor and complete various questionnaires and sleep diaries. On day 2 you will be 
asked to collect saliva samples every 30 minutes, starting 6 hours before your bedtime. On one 
of the nights between days 5 and 10, 2 members from the research team will visit your home to 
conduct an unattended in-home sleep recording.
Key Information: 
The first few pages of this document include a summary of this study to help you 
decide whether or not to participate. Detailed information is provided after the 
summary.
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 2 of 10
Version Date: 03/08/2018
Within 1 week of the in-home assessment, you will have another overnight visit in the Hospital 
Clinical Research Unit. We will collect saliva samples every 30 minutes, starting 6 hours before 
bedtime as was done at home. Blood pressure and heart rate will be continuously recorded 
during this time, and urine will be collected until morning. The following morning, body fat will be 
measured and an oral glucose tolerance test will be performed, similar to the one conducted 
during the screening visit but lasting 5 hours.
More detailed information about the study procedures can be found under the section What 
happens if I say “Yes, I want to be in this research”?
Is there any way being in this study could be bad for me?
You may experience slight irritation at the site where polysomnography sensors are placed. You 
may also experience pain, irritation, or inflammation from the IV insertion and blood draws. 
Irritation is typically temporary and care will be taken to prevent it. There is a risk of loss of 
confidentiality, but all personal information will be kept in locked cabinets. 
More detailed information about the risks of this study can be found under “Is there any way 
being in this study could be bad for me? (Detailed Risks)”
Will being in this study help me in any way?
There are no benefits to you from your taking part in this research. We hope the information 
learned from this study will help us further understand the relationship between sleep and 
diabetes.
Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the 
research team at (312) 503-4965 or Dr. Kristen Knutson at (312) 503-1526.
This research has been reviewed and approved by an Institutional Review Board (IRB). You 
may talk to them at (312) 503-9338 or irb@northwestern.edu if:

Your questions, concerns, or complaints are not being answered by the research team.

You cannot reach the research team.

You want to talk to someone besides the research team.

You have questions about your rights as a research participant.

You want to get information or provide input about this research.
How many people will be studied?
We expect about 200 people will consent to be in this research study. 
What happens if I say “Yes, I want to be in this research”?
There are three parts to this study.  
1.
A health screening
2.
An in-home assessment
3.
A laboratory session
Detailed Information:
The rest of this document includes detailed information about this study (in addition to the 
information listed above).
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 3 of 10
Version Date: 03/08/2018
Screening:  One single overnight stay followed by approximately 4 hours in the laboratory.
In order to determine if you can participate in this study, you will go through a screening 
procedure. You will be asked to stay overnight in the Sleep Laboratory or Clinical Research 
Center in order to analyze your sleep to determine if you have any sleep disorders. 
The screening will include the following: 

A sleep study with electrodes (sensors) pasted on your head to measure your brain waves 
and on your legs to measure your leg movements. You will also be wearing sensors that 
will be put in front of your nose, around your chest and belly to measure your breathing 
and a small sensor will be taped on your finger to measure your blood oxygen level 
(without collecting any blood) overnight.

The next morning, you will have an oral glucose tolerance test (OGTT). For this test you 
will fast (only water and no food) beginning at 9 pm the night before the OGTT. In the 
morning a small flexible needle (an IV) will be inserted into a vein of your arm to allow for 
blood samples to be drawn. You will be given a drink (about 1 1/3 cups) which contains 75 
grams of glucose (sugar). You will be asked to drink this sugar mix over 5 minutes. Twice 
before taking the drink and then 2 hours after drinking the sugar solution, approximately 
1/3 of a teaspoon of blood will be drawn for measurement of glucose (sugar) levels. To 
allow for continuous blood sampling from the IV, a small amount of saline will run through 
the IV. In total less than 1 teaspoon of blood will be drawn during this test. This oral 
glucose tolerance test is designed to determine if your pancreas responds normally to this 
oral glucose challenge. 

You will also have a medical history, a physical examination, and urine drug screening. 
Also, during the OGTT, an additional 2 tablespoons of blood will be drawn for a complete 
blood count (CBC), liver, and kidney tests, and a urine pregnancy test for women. If you 
are pregnant, you will not be able to participate. If your blood count is low you may be 
given iron supplements and asked to come back for a repeat blood count in about 3 
weeks.  If the results of this test are normal you will be allowed to participate. We will also 
ask you to complete questionnaires of sleep, mood, energy, hunger, and appetite. The 
answers to some of the questions on the mood questionnaires could suggest that you 
have depressive symptoms.  If so, you will be given the University of Chicago mental 
health clinic phone number for follow-up care.
In-home Assessment:  
The In-home Assessment will last 10 days (see outline below) during which you will 
continuously wear a waterproof wrist activity monitor and complete sleep diaries to estimate 
sleep duration and timing.  The activity monitor is a way we can get an idea of your sleep 
patterns by looking at the movements of your wrist.  The monitor also measures the light in the 
room.  You will also complete a 3-day food diary that asks for both the amount and types of food 
eaten and time of meals and snacks.  On the first and second day you will be instructed to 
abstain from caffeine and alcohol and that afternoon and evening, and you are also asked to 
avoid taking any non-steroidal anti-inflammatory drugs (“NSAIDS”), including aspirin, ibuprofen 
(Motrin), and naproxen (Aleve, Naprosyn).  We will give you a complete list of these drugs. On 
the second day you will be instructed to collect saliva samples every 30 minutes beginning 6 
hours before your bedtime up until bedtime.  We will ask you to tell us what your usual bedtime 
is in order to schedule this session.  You will visit the laboratory either the day before Day 1 or 
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 4 of 10
Version Date: 03/08/2018
on Day 1 or 2 in order to get all the equipment and the specific instructions on how to collect 
these samples. On one of the nights between days 5 and 10, two research team members will 
visit your home to pick up the saliva samples and to set up one night of unattended in-home 
sleep recording (“PSG”).  The sleep study will include these sensors as in the screening sleep 
study.  A sound meter and light sensor will be placed in your bedroom to measure sound and 
light levels during your sleep period. One of them will return in the morning to pick up this 
equipment. During this week, you will also complete questionnaires that ask about your sleep 
habits, time of day preferences for various activities, and several measures of mood and health.  
Outline of In-Home Assessment
Day
Description
Note:
1
Start wearing wrist activity monitor & complete sleep log
No alcohol, caffeine or NSAIDS
2
Saliva sampling day!
No alcohol, caffeine or “NSAIDS” (see list)
Must be home at least one hour before first sample.  (See 
instruction sheet)
Must wear the provided sunglasses (included in the saliva 
sampling package provided)
Continue to wear wrist activity monitor & complete sleep log
You will visit the 
laboratory to receive 
instructions and pick up 
the equipment either the 
day before day 1 or on 
day 1 or 2 depending on 
scheduling.
3
Start Questionnaire packet (please finish them by last day)
Continue to wear wrist activity monitor & complete sleep log
4
Continue to wear wrist activity monitor & complete sleep log
5
Continue to wear wrist activity monitor & complete sleep log
6
Continue to wear wrist activity monitor & complete sleep log
7
Complete Day 1 of Food Diary
Continue to wear wrist activity monitor & complete sleep log 
8
Complete Day 2 of Food Diary
Continue to wear wrist activity monitor & complete sleep log 
9
Complete Day 3 of Food Diary
Continue to wear wrist activity monitor & complete sleep log 
One of these nights will 
involve a visit by the 
research team to set up 
the sleep recording 
system and pick up 
saliva samples.
10
Complete last day of sleep log
Continue to wear wrist activity monitor
Hold on to all materials – wrist monitor, logs & 
questionnaires – and bring with you to laboratory 
session.
Laboratory Session:  
Within one week of the in-home assessment, you will spend approximately 21 hours in the 
laboratory. The day of your laboratory session, you will be instructed to abstain from caffeine 
and alcohol and you are also asked to avoid taking any non-steroidal anti-inflammatory drugs 
(“NSAIDS”), including aspirin, ibuprofen (Motrin), and naproxen (Aleve, Naprosyn).  We will give 
you a complete list of these drugs. Please arrive at the laboratory between 5:00 PM and 5:15 
PM.  Saliva samples will be collected every 30 minutes between 5:25 PM and bedtime at 10:00 
PM.  Blood pressure will be recorded continuously between 6:00 PM and 2:00 AM.  Your 
questionnaires will be reviewed by study personnel and a fourth food diary day will be 
completed.  Time in bed in the laboratory will be 10:00 PM to 8:00 AM.  Sleep will be recorded 
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 5 of 10
Version Date: 03/08/2018
using wrist activity monitoring. We may also record sleep using PSG if the home PSG did not 
work. Urine samples will be collected from 6:00 PM until the first morning void the next morning. 
In the morning, body fat will be measured.  Then, an oral glucose tolerance test (OGTT) with 12 
blood samples taken through an IV every 10-30 minutes over 5 hours will be performed.  Total 
amount of blood withdrawn will be approximately 5 tablespoons. Electrocardiogram (ECG) will 
be measured continuously.  After the OGTT you will be given lunch and then you are free to 
leave. 
Outline of Laboratory Session
Day
Description
1

No alcohol, caffeine or NSAIDS 

Continue to wear wrist activity monitor 

Arrive at lab between 5:00 & 5:15 PM

Heart rate monitoring (ECG) begins and continues throughout the 
session

Must wear the provided sunglasses.

Saliva samples will be collected every 30 minutes between  5:30 and 
10:00PM

Blood pressure recording begins at 6:00PM and continues until 2:00AM  

Sleep measured with sleep recording system and wrist activity 
monitoring

Urine will be collected from 6:00 PM onwards

Dinner will be provided
2

Wake up at 8:00 AM

First morning urine will be collected

Heart rate monitoring continues

Body fat percentage measured

5-hour Oral glucose tolerance test (involves taking blood)

Lunch at approximately 2:00 PM 
During this study, Dr. Kristen Knutson and her research team will collect information about you 
for the purposes of this research. This information includes the following: height, weight, 
measure of body fat, blood pressure and heart rate recordings, and blood and urine tests for 
kidney and liver function, hormone response to a sugar load, and some hormone levels. We 
also collect sleep data, wrist activity monitoring data, and questionnaires about sleep, mood and 
appetite and alertness, food diaries, dates, e-mail address, names, telephone numbers, and 
social security number (for payment purposes).
What are my responsibilities if I take part in this research?
If you take part in this research, you will be responsible for completing the procedures, 
assessmens, and visits stated above. You are also responbile for communicating with the study 
coordinator or investigator when you are unable to or unwilling to continue to study.
What happens if I say “Yes”, but I change my mind later?
You can leave the research at any time it will not be held against you.
If you decide to leave the research, contact the study coordinator or investigator so that they 
can cancel scheduled visits and assess the payment you qualify for according to the breakdown 
detailed later in this document. 
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 6 of 10
Version Date: 03/08/2018
Choosing not to be in this study or to stop being in this study will not result in any penalty to you 
or loss of benefit to which you are entitled.  Specifically, your choice not to be in this study will 
not negatively affect your right to any present or future medical treatment, your class standing 
(for students enrolled in a class at NU), or your present or future employment (for employees at 
NU or its affiliates).
Detailed Risks: Is there any way being in this study could be bad for me?
This research may hurt you in the following ways: 

There is a slight risk of irritation at the site of the electrode (sensor) placement for 
polysomnography.  This irritation would be temporary and care will be taken to avoid any 
irritation.

There is the risk of loss of confidentiality of your information.  All data will be kept in locked 
cabinets in research offices and care will be taken to prevent loss of confidentiality.

Temporary pain, slight bruising, possible inflammation, and possible fainting may occur from 
IV insertion during the oral glucose tolerance tests.

Low blood glucose levels during the oral glucose tolerance test may also result in 
lightheadedness, rapid heartbeat, irritability, shakiness, headache, and fainting.  
Care will be taken to avoid these complications. An experienced research nurse will insert the IV 
under sterile conditions, and glucose levels are measured immediately, so if levels get too low, 
the test will be stopped and juice will be provided.
This study involves the use of your identifiable, personal information and there is a chance that 
a loss of confidentiality could occur. The researchers have procedures in place to reduce the 
possibility of this happening.  See the section below titled: “What happens to the information 
collected for the research?”. 
Will it cost me anything to participate in this research study?
Taking part in this research study will not lead to any costs to you or your insurance company. 
However, you or your insurance company will be responsible for costs related to your usual 
medical care. 
What happens to the information collected for the research?
Study records that identify you will be kept confidential. Study records will be kept in a locked 
office and are only accessible by members of the research team. Data will be coded so that you 
are not identified and will not contain information that can identify you. The data collected in this 
study will be used for the purpose described in the form. Data from this study may be used in 
medical publications or presentations. Your name and other identifying information will be 
removed before this data is used. If we wish to use identifying information in publications, we 
will ask for your approval at that time. 
Efforts will be made to limit the use and disclosure of your personal information to people who 
have a need to review this information. We cannot promise complete secrecy. Organizations 
that may inspect and copy your information include the IRB and other representatives of this 
institution. The research team includes the individuals listed on this consent form and other 
personnel involved in this study at the Northwestern University and Rush University. As part of 
the study, Dr. Knutson and her research team may report the results of your study-related 
procedures and tests explained above to the National Institutes of Health (NIH).  These include 
the information from the wrist activity monitor, the sleep recording and the questionnaires, as 
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 7 of 10
Version Date: 03/08/2018
well as your age, sex, ethnicity, height and weight.  The information being sent will not contain 
any information that identifies you.  
Plasma from blood samples and saliva samples collected during your laboratory session will be 
retained and stored either in the CRU at Northwestern or the Endocrinology Lab at the 
University of Chicago until primary analysis can be done, once analyzed they will be destroyed. 
All samples will be deidentified using only the study ID code. After the saliva specimens 
collected at home are assayed at Rush University by the co-investigator Dr. Helen Burgess, 
they will be destroyed. In this study, you will be asked about illegal activities or highly personal 
behavior. We have obtained a Certificate of Confidentiality from the federal government. 
However, we may still be required under certain circumstances to release your information. 
The sponsor, monitors, auditors, the IRB, the Northwestern University Office for Research 
Integrity, the US Office of Research Integrity (ORI), the US Office for the Protection of Human 
Research Protections (OHRP), the US Food and Drug Administration (FDA) may be granted 
direct access to your medical records to conduct and oversee the research. By signing this 
document you are authorizing this access. We may publish the results of this research. 
However, we will keep your name and other identifying information confidential.
Data Sharing
De-identified data from this study may be shared with the research community at large to 
advance science and health. We will remove or code any personal information that could 
identify you before files are shared with other researchers to ensure that, by current scientific 
standards and known methods, no one will be able to identify you from the information we 
share. Despite these measures, we cannot guarantee anonymity of your personal data.
Can I be removed from the research without my OK?
The person in charge of the research study or the sponsor can remove you from the research 
study without your approval. Possible reasons for removal include:

You are unable to meet the requirements of the study;

Your medical condition changes;

If the study is stopped.
We will tell you about any new information that may affect your health, welfare, or choice to stay 
in the research.
What else do I need to know?
If you become ill or get injured as a result of this study (medications, devices or procedures), 
you should seek medical treatment through your doctor or treatment center of choice. You 
should promptly tell the study doctor about any illness or injury.  
The hospital [university, researchers] will not pay for medical care required because of a bad 
outcome resulting from your participation in this research study. This does not keep you from 
seeking to be paid back for care required because of a bad outcome.
Payment
If you agree to take part in this research study, we will pay you a total amount of $450 for 
completing the study.  

$50 for the screening, including both the sleep study (PSG) and the glucose tolerance 
test.
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 8 of 10
Version Date: 03/08/2018

$150 for the in-home assessment if all components are completed, including a minimum 
of 5 days of wrist activity monitoring, the saliva samples and the PSG sleep recording.

$250 for the laboratory session, including the blood pressure monitoring, saliva samples 
and 5-hour glucose tolerance test.

You will receive the amount indicated for each component if that component is 
completed as described.
Payment will be made by check and mailed out to you. The processing time is about 4-6 weeks 
after completion of the last inpatient visit. The Accounting Services at Northwestern University 
will be given your name, address, and Social Security Number in order to issue a check for your 
study participation. Study payments are considered taxable income and reportable to the IRS. A 
Form 1099 will be sent to you if your total payments are $600 or more in a calendar year.
HIPAA Authorization
We are committed to respect your privacy and to keep your personal information confidential.  
When choosing to take part in this study, you are giving us the permission to use your personal 
health information that includes health information in your medical records and information that 
can identify you. For example, personal health information may include your name, address, 
phone number or social security number. Your health information we may collect and use for 
this research includes:

All information in a medical record 

Results of physical examinations

Medical history including an mental health diagnosis 

Lab tests, or certain health information indicating or relating to a particular condition as 
well diaries and questionnaires

History of substance or alcohol abuse 

History of mental health disorders (e.g. depression, anxiety) including prescribed 
medications, doses, and length of use. 
During this study you may be coming to a Northwestern Memorial Healthcare Corporation entity 
(for example, Northwestern Memorial Hospital, Prentice Women’s Hospital) for research 
appointments or to get clinical services, such as lab tests, needed for the study.  When that 
happens, you will be scheduled for these services through the NMHC computer system.  When 
a clinical exam or lab is done by NMHC or one of its employees for the purpose of this research 
study, that information will be kept in both NMHC’s clinical records and in the study records.
The following clinical providers may give the researchers information about you:  all current and 
previous health care providers, including but not limited to the Rehabilitation Institute of Chicago 
(RIC), Northwestern Medical Group (NMG), Northwestern Memorial Hospital (NMH), 
Northwestern Lake Forest Hospital (NLFH).
Once we have the health information listed above, we may share some of this information with 
the following offices or entities outside of Northwestern University and its clinical partners (or 
affiliates):  the Northwestern University Institutional Review Board Office and Office for 
Research Integrity; the US Office of Research Integrity; the US Office for Human Research 
Protections; the US Food and Drug Administration.  
Any research information shared with outside entities will not contain your name, address, 
telephone or social security number or any other personal identifier unless disclosure of the 
identifier is necessary for review by such parties or is required by law or University policy 
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 9 of 10
Version Date: 03/08/2018
[except that such information may be viewed by the Study sponsor and its partners or 
contractors at the Principal Investigator’s office].

Authorized members of the Northwestern University workforce, who may need to see 
your information, such as administrative staff members from the Office for Research, 
Office for Research Integrity and members of the Institutional Review Board.

Clinical affiliates, including but not limited the Rehabilitation Institute of Chicago (RIC), 
Northwestern Medical Group (NMG), Northwestern Memorial Hospital (NMH), 
Northwestern Lake Forest Hospital (NLFH), and the Ann & Robert H. Lurie Children’s 
Hospital of Chicago (Lurie Children’s).  Your participation in this clinical trial may be 
tracked in an electronic database and may be seen by investigators running other trials 
that you are enrolled in and by your healthcare providers.

Clinical affiliates, including but not limited to Northwestern Medical Group (NMG), 
Northwestern Memorial Hospital (NMH), and Northwestern Lake Forest Hospital (NLFH), 
for purposes including, but not limited to, the affiliate’s provision of care to you and/or the 
affiliate’s scheduling of appointments and/or billing activities.

Other University research centers and University contractors who are also working on 
the study,

Study monitors and auditors who make sure that the study is being done properly, 

Government agencies and public health authorities, such as the Food and Drug 
Administration (FDA) and the Department of Health and Human Services (DHHS).
Those persons who get your health information may not be required by Federal privacy laws 
(such as the Privacy Rule) to protect it. Some of those persons may be able to share your 
information with others without your separate permission.
However, Illinois law does not allow the re-release of HIV/AIDS, genetic testing, mental health 
and developmental disabilities information by the recievers of the information except in precise 
situations allowed by law. 
Also, Federal Confidentiality Rules, 42 CFR Part 2, prohibit making any further disclosure of 
substance use disorder information unless further disclosure of this information is expressly 
permitted by written consent of the person to whom it pertains or as otherwise permitted by 42 
CFR Part 2. 
The results of this study may also be used for teaching, publications, or for presentation at 
scientific meetings.  
Unless you revoke your consent, it will expire at the end of the research study. 
Although you may revoke consent to participation in this research at any time and in any format, 
you must revoke authorization for use or disclosure of your health information in writing. To 
revoke your authorization, write to:
Kristen L. Knutson, PhD 
Center for Circadian and Sleep Medicine
Department of Neurology
Northwestern University Feinberg School of Medicine
710 N Lakeshore Drive, Room 523
Chicago, IL  60611
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019

Permission to Take Part in a Human Research Study
Do not sign this consent if today’s date is later than the stated expiration date above.
Page 10 of 10
Version Date: 03/08/2018
You do not have to authorize the use or disclosure of your health information; however, you will 
not be allowed to take part in this research study. If you do not authorize the use or disclosure of 
your health information, it will not affect your treatment by health care providers, or the payment 
or enrollment in any health plans, or affect your eligibility for benefits.
A copy of this signed consent document, information about this study, and the results of any test 
or procedure done may be included in your medical records and may be seen by your insurance 
company.
Optional Elements:
The following research activities are optional, meaning that you do not have to agree to them in 
order to participate in the research study. Please indicate your willingness to participate in these 
optional activities by placing your initials next to each activity.
I agree
I disagree
_______
_______
The researcher may contact me after I have finished participating 
in the study to clarify and ask questions about my responses to 
questionnaires and my performance on study activites.
_______
_______
The researcher may contact me in the future to see whether I am 
interested in participating in other research studies by the 
Principal Investigator of this study.
_______
_______
The researcher may retain any leftover blood or tissue samples 
taken during the study. These samples may be used for other 
research not related to this study. These samples will be retained 
in non-identifiable form, meaning that there will be no information 
associated with the blood or samples that will allow anyone to 
readily ascertain my identity. 
Your signature documents your permission to take part in this research.  You will be provided a 
copy of this signed document.
_______________________________________________      __________________
Signature of Participant                                                               Date
_______________________________________________
Printed Name of Participant
____________________________________________            __________________
Signature of Person Obtaining Consent                                     Date
______________________________________________________
Printed Name of Person Obtaining Consent
IRB #: STU00204605 Approved by NU IRB for use on or after 3/5/2019