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Active Studies

Explore our members' current research projects below. These studies are currently active but may not be in the recruiting phase. For information about studies currently recruiting participants, please see our Participate in a Research Study page.

 Survey of Sleep and Physical Activity Across a Lifetime

Principal Investigator: Phyllis C. Zee, MD, PhD

IRB Study: #STU00206195

Are you 50 years of age or older and have/or have had a spouse in your lifetime? The Circadian Rhythms and Sleep Research Laboratory at the Feinberg School of Medicine at Northwestern University is currently conducting a research study (Survey of Sleep and Physical activity Across a Lifetime, IRB# STU00206195, led by Dr. Phyllis C. Zee) to examine whether there is a relationship between physical activity as a young person and health outcomes in older age in relationship with sleep.

The study will require you to complete a questionnaire about the sleep, physical activity and health for yourself and your spouse. The questionnaire should take 30 minutes or less to complete. Compensation will not be provided.

If you are interested in participating, please complete this survey.

 Strengthening Circadian Signals

Principal Investigator: Phyllis Zee, MD, PhD

IRB Study #: STU00206038

The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study is to determine the impact of when you eat and melatonin on improving sleep and health in older adults who are at risk of disorders such as diabetes, heart diseases or stroke.

Eligibility Criteria

Men and women age 35-54 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.

Participant Requirements

This study will consist of 10 visits completed over a six-to-nine-month period. Two visits will be overnight in-patient visits lasting 4-days/3-nights, and eight visits will be out-patient visits lasting approximately one to five hours each.

Visit 1 - Screening
Prospective participants will come to the Circadian Rhythms and Sleep Lab located in the Chicago Northwestern campus. This visit will take approximately one to two hours to complete. During this visit, you will get all the details about the study and role as a participant. You will be asked to sign a consent form. You will undergo a medical history and assessment interview. You will be asked to complete surveys and questionnaires. Eligible participants will be asked to complete a food and sleep diary for up to seven days following the visit. Participants will also wear a wrist activity monitor for up to seven days and complete a home sleep test to determine further eligibility. All the data from this visit will be reviewed and eligible participants will be contacted to continue with the study.

Visit 2 - Outpatient
This visit will take place at the Circadian Rhythms and Sleep Lab located in the Chicago Northwestern campus. Prior to this visit, you will be complete a phone interview with a bio-nutritionist to examine your food schedule/intake. At this visit, participants will be asked to wear a wrist activity monitor for seven days and complete food/sleep diaries. Participants will also use a phone application to take picture of food/drinks ingested for up to seven days. Participants will also complete a 14-day recording of glucose using a continuous glucose monitor set up by study staff and a seven-day recording of heart rate using an adhesive patch placed on the chest that transmits data to a phone application.

Visit 3 - Inpatient
This visit will take place at the clinical research unit located in Northwestern Memorial Hospital in downtown Chicago 7 to 14 days after completing visit 2. This visit will be a 4-day/3-night inpatient stay at the hospital. A number of procedures will occur during this visit, including a standard sleep recording each night, ECG recording, urine collection, stool collection, blood samples collection, continuous blood pressure monitoring for a period of time and other procedures completed by trained hospital staff. At end of the visit, participants will be given either a melatonin supplement or placebo pill to take 30 minutes prior to bedtime for the next six weeks and will be given specific instructions to follow based on intervention group. Participants will be asked to continue completing food/sleep diaries, wrist activity monitoring, up to 14 days of recording of glucose monitoring and up to 7-days of heart rate recording as before.

Visit 4 – Outpatient
This visit will take place at the clinical research unit located in Northwestern Memorial Hospital in downtown Chicago 7 to 14 days after completing visit 3. At this visit, participants will complete a brief physical examination, some questionnaires, and a 3-hour Oral Glucose Tolerance Test. For this test, participants will drink a sugar solution and have 10 blood samples taken to measure their tolerance to sugar. This visit will take up to 5 hours. At end of the visit, participants will be instructed to continue taking either the melatonin or placebo supplement and follow the instructions provided based on the intervention group.

Visits 5-8 – Outpatient
These assessments will take place either remotely or at the Circadian Rhythms and Sleep Lab located in the Chicago Northwestern campus starting seven to fourteen days after completing visit 4. These assessments will be scheduled seven to fourteen days apart and will take one to two hours to complete. Participants will be asked to continue completing food/sleep diaries and wrist activity monitoring.

Visit 9 – Inpatient
This visit will take place at the clinical research unit located in the Northwestern Memorial Hospital in downtown Chicago 7 to 14 days after completing visit 8. This visit will be a four-day/three-night inpatient stay at the hospital. Participants will complete the same procedures and follow same schedule as visit 3. Prior to the visit, participants will be asked to complete the final 14-day recording of glucose and seven-day recording of heart rate. Participants will stop taking the melatonin or placebo supplement and follow intervention instructions at this visit.

Visit 10 – Outpatient
This visit will take place at the outpatient clinical research unit located in Northwestern Memorial Hospital in downtown Chicago three months after completing visit 9. This visit will take one to two hours to complete. Prior to this visit, participants will be asked to complete a seven-day recording of wrist activity monitoring and complete food/sleep diaries as before. Participants will undergo an interview with study team at this visit and will get debriefed on the study at the end of the visit.

Participant Compensation

Participants will be paid up to $2,850 for completing all study procedures. The compensation is prorated based on completion of procedures as follows. Participants will be compensated $110 for completing the screening visit and returning all equipment. For completing Visit 2 and at-home procedures, you will be paid $125.  For completing the first in-patient visit 3, you will be paid $545; for completing visit 4, you will be paid $245; for completing the extended intervention procedures, you will be paid $150 per week up to $750; for completing the second in-patient visit 9, you will be paid $500; and finally for completing the follow up visit 10, you will be paid $150.

Participant Risk & Benefit

Participation in the study may involve the following risks. The placement of electrodes on the scalp and face may cause skin irritation. The potential risks of blood drawing include a bruise at site of vein or finger puncture, redness, and swelling; care will be taken to avoid these potential risks. If you are placed in the intervention group that requires you to take melatonin supplement, you may experience some side effects from it such as headaches, vivid dreams, and drowsiness. The study team will be in contact with you throughout the study and contact information will be available to you if you experience any side effects.

The study doesn’t guarantee any benefits to you or others for taking part in this research. However, possible benefits include opportunity to have screening for sleep disorders and cardiometabolic disease risk factors evaluated at no costs. If study team finds any sleep disorders or other disease risk factors, participants will be informed.

Learn More

If you would like more information about the study and are interested in participating, you can contact the study team through email at CCSMResearch@northwestern.edu or phone at 312-503-1948, or you can fill out a short survey and you will be contacted by study team shortly if you are eligible to continue with study.

 PPG-6: Alteration of Sleep and Circadian Timing in Aging

Principal Investigator: Phyllis Zee, MD, PhD

IRB Study #: STU00206014

The purpose of this research is to determine whether when you eat and taking melatonin (a hormone naturally produced by the body) can improve health and sleep. There is growing body of evidence that disrupted sleep and circadian rhythms have negative effects on health. The goal of this study is to determine the impact of when you eat and melatonin on improving sleep and health in older adults who are at risk of disorders such as diabetes, heart diseases or stroke.

Eligibility Criteria

Men and women ages 55-75 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.

Participant Requirements

This study will consist of 10 visits completed over a six-to-nine-month period. Two visits will be overnight in-patient visits lasting four days/three nights, and eight visits will be out-patient visits lasting approximately one to five hours each.

Visit 1 - Screening: Prospective participants will come to the Circadian Rhythms and Sleep Lab located in the Chicago Northwestern campus. This visit will take approximately two hours to complete. During this visit, you will get all the details about the study and role as a participant. You will be asked to sign a consent form. You will undergo a medical history and assessment interview. You will be asked to complete surveys and questionnaires. Eligible participants will be asked to complete a food and sleep diary for up to seven days following the visit. Participants will also wear a wrist activity monitor for up to seven days and complete a home sleep test to determine further eligibility. All the data from this visit will be reviewed and eligible participants will be contacted to continue with the study.

Visit 2 - Outpatient: This visit will take place at the Circadian Rhythms and Sleep Lab located in the Chicago Northwestern campus. Prior to this visit, you will be complete a phone interview with a bio-nutritionist to examine your food schedule/intake. At this visit, participants will be asked to wear a wrist activity monitor for seven days and complete food/sleep diaries. Participants will also use a phone application to take picture of food/drinks ingested for three days. Participants will also complete up to 14 days of glucose recording using a continuous glucose monitor which will be set up by study staff and up to seven days recording of heart rate using an adhesive patch placed on the chest that transmits data to a phone application.

Visit 3 - Inpatient: This visit will take place at the clinical research unit located in Northwestern Memorial Hospital in downtown Chicago 7 to 14 days after completing visit 2. This visit will be a four-day/three-night inpatient stay at the hospital. A number of procedures will occur during this visit, including a standard sleep recording each night, ECG recording, urine collection, stool collection, blood samples collection, continuous blood pressure monitoring for a period of time and other procedures completed by trained hospital staff. At end of the visit, participants will be given either a melatonin supplement or placebo pill to take 30 minutes prior to bedtime for the next six weeks and will be given specific instructions to follow based on intervention group. Participants will be asked to continue completing food/sleep diaries, wrist activity monitoring, another up to 14-day recording of glucose monitoring and up to seven-day heart rate recording as before.

Visit 4 – Outpatient: This visit will take place at the outpatient clinical research unit located in Northwestern Memorial Hospital in downtown Chicago 7 to 14 days after completing visit 3. At this visit, participants will complete a brief physical examination, some questionnaires, and a 3-hour Oral Glucose Tolerance Test. For this test, participants will drink a sugar solution and have 10 blood samples taken to measure their tolerance to sugar. This visit will take up to 5 hours.

Visit 5-8 – Outpatient: These assessments will take place remotely or at the Circadian Rhythms and Sleep Lab located in the Chicago Northwestern campus starting seven to fourteen days after completing visit 4. These assessments will be scheduled seven to fourteen days apart and will take one to two hours to complete. Participants will be asked to continue completing food/sleep diaries and wrist activity monitoring.

Visit 9 – Inpatient: This visit will take place at the clinical research unit located in the Northwestern Memorial Hospital in downtown Chicago 7 to 14 days after completing visit 8. This visit will be a four-day/three-night inpatient stay at the hospital. Participants will complete the same procedures and follow same schedule as visit 3. Prior to the visit, participants will be asked to complete the final up to 14-day recording of glucose and up to seven-day recording of heart rate. Participants will stop taking the melatonin or placebo supplement and follow intervention instructions at this visit.

Visit 10 – Outpatient: This visit will take place at the outpatient clinical research unit located in Northwestern Memorial Hospital in downtown Chicago three months after completing visit 9. This visit will take one to two hours to complete. Prior to this visit, participants will be asked to complete a seven-day recording of wrist activity monitoring and complete food/sleep diaries as before. Participants will undergo an interview with study team at this visit and will get debriefed on the study at the end of the visit.

Participant Compensation

Participants will be paid up to $2,850 for completing all study procedures. The compensation is prorated based on completion of procedures as follows. Participants will be compensated $110 for completing the screening visit and returning all equipment. For completing Visit 2 and at-home procedures, you will be paid $125. For completing the first in-patient visit 3, you will be paid $545; for completing the one-week acute based field intervention procedures, you will be paid $150/week up to $300; for completing visit 4, you will be paid $245; for completing the extended based field intervention procedures, you will be paid $150/week up to $750; for completing the second in-patient visit 9, you will be paid $500; and finally for completing the follow-up visit 10, you will be paid $150.

Participant Risk & Benefit

Participation in the study may involve the following risks. The placement of electrodes on the scalp and face may cause skin irritation. The potential risks of blood drawing include a bruise at site of vein or finger puncture, redness and swelling; care will be taken to avoid these potential risks. If you are placed in the intervention group that requires you to take melatonin supplement, you may experience some side effects from it such as headaches, vivid dreams and drowsiness. The study team will be in contact with you throughout the study and contact information will be available to you if you experience any side effects.

The study doesn’t guarantee any benefits to you or others for taking part in this research. However, possible benefits include opportunity to have screening for sleep disorders and cardiometabolic disease risk factors evaluated at no costs. If study team finds any sleep disorders or other disease risk factors, participants will be informed.

Learn More

If you would like more information about the study and are interested in participating you can contact the study team through email at CCSMResearch@northwestern.edu or phone at 312-503-1948, or you can fill out a short survey and you will be contacted by study team shortly if you are eligible to continue with study.

 Home Sleep and Circadian Phase: Mediators of Racial Disparities in Diabetes Risk
Principal Investigator: Kristen Knutson, PhD
IRB Study #: STU00204605

Screening includes overnight stay with a full sleep study and morning blood tests. If you qualify, the full study includes oneweek of wrist actigraphy at home, saliva collectioning at home for one evening, home visit by study staff and a second overnight stay with blood tests the next morning.

Eligibility Criteria

Ages 21-50. African-American or Caucasian. Healthy adult.

Location

710 N. Lake Shore Dr., Chicago, IL.

Learn More

Complete a web survey to see if you are eligible.

For more information or to inquire about participation, contact the Circadian Rhythms and Sleep Research Lab via email at matthew.brenner-jedwabnik@northwestern.edu or by phone at 312-503-4965.

 Auditory Stimulation of Slow Wave Sleep and Memory in Mild Cognitive Impairment and Older Adults

Principal Investigator: Roneil Malkani, MD, MS

This study will evaluate the ability of sounds played during slow wave sleep using a phase locked loop algorithm to enhance slow wave sleep and memory in cognitively healthy older adults and in those with amnestic mild cognitive impairment.

Alzheimer's disease is a degenerative disorder associated with aging and presents a significant human and financial burden. Amnestic mild cognitive impairment (aMCI) is a disorder of impaired memory and is a precursor to Alzheimer's disease. Current treatments are symptomatic and do not slow disease progression. There is increasing evidence linking sleep and cognition, such that decreased sleep, particularly slow wave sleep (physiologically slow wave activity; SWA), is associated with impaired cognitive performance. Not only does SWA decrease with aging, it is much less in people with aMCI than cognitively normal elderly. Interventions that improve sleep may also improve cognition. Auditory stimulation using sounds played through headphones or speakers during sleep have been shown to increase SWA and memory in young adults. Because this method plays sounds at fixed intervals, its ability to enhance SWA may be limited. Investigators have developed an improved method that measures slow waves during sleep in real time and delivers the sound at a particular phase of the slow wave (phase locked loop; PLL). Given that people with aMCI have low SWA, this method may be able to improve cognition by enhancing SWA. Our objective is to determine whether the PLL method of auditory stimulation can increase SWA and improve cognition in people with aMCI. Investigators propose a randomized sham-controlled cross-over study of auditory stimulation that population.

Eligibility Criteria

Men and women 60 years and older with a diagnosis of Mild Cognitive Impairment (MCI) as well as individuals with intact cognitive profile based on neuropsychology testing within 1 standard deviation for age and education status.

Participation Requirements

Participants will undergo two nights of polysomnography (stimulation and sham) and cognitive testing. There will be approximately one week between overnight visits. The order of stimulation and sham will be randomized. Stimulation consists of quiet pulses of pink noise being played during slow-wave sleep (deep sleep). Participants will also complete short memory tests before and after sleep.

Compensation

Participants will be compensated $75 for each overnight visit. Visits begin at 6 p.m. and are finished two hours after wake. Meals, travel expenses and parking will be covered by the study.

Learn More

To learn more, contact Nelly Papalambros at 312-503-3985 or pap@u.northwestern.edu.

 Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease (U10)

Principal Investigator: William Grobman, PhD

Define the relationship between APOs and markers of cardiovascular disease risk (CVDR) at two years after delivery.

Recent epidemiologic studies suggest that women with adverse pregnancy outcomes (APOs), such as preeclampsia, are at increased risk for subsequent cardiovascular diseases. However, prospective data to elucidate the precise relationship between adverse pregnancy outcomes and subsequent cardiovascular disease are lacking. To address this critical knowledge gap, the NHLBI issued a RFA to study pregnancy as a window to future maternal health.

In this study, a multidisciplinary team with diverse talents and expertise will define the relationship between APOs and markers of cardiovascular disease risk (CVDR) at two years after delivery. This multicenter group will utilize an ethnically, racially, socioeconomically and geographically diverse cohort of 10,000 nulliparous women enrolled in the NICHD-funded Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b). This new study will leveraged the extensive and unique database and tissue bank developed in the parent study in which nulliparous women are evaluated over the course of pregnancy to study the mechanisms for and prediction of APOs. Women enrolled in the nuMoM2b cohort are extremely well phenotyped through prospective data collection, clinical evaluations, and ultrasound assessments, as well as through the use of standardized definitions. Demographic, psychosocial, dietary, physiologic, and outcome information is collected through maternal interviews, self-administered questionnaires, clinical measurements, ultrasounds, and medical record abstraction by trained personnel. Samples of maternal blood, urine, and cervico-vaginal fluid over pregnancy and cord blood and placenta at delivery are collected and banked. All women complete two sleep questionnaires and over 3,600 are recruited to perform objective overnight sleep studies at two times during pregnancy.

Participation Requirements

Women participating in the nuMoM2b parent study will be assessed for evidence of CVDR, including sleep disordered breathing (SDB), at two to three years postpartum. APOs in subsequent pregnancies also will be assessed. These studies will characterize the relationship between APOs and CVDR, identify first pregnancy profiles that portend subsequent CVDR, determine associations between SDB during the first pregnancy and subsequent CVDR, and identify modifiable factors that mediate the associations between CVDR and APOs in the first and subsequent pregnancy. This will allow for the development of strategies to modify these CVDR factors and to improve the health of women suffering APOs.

Learn More

For more information, contact Peggy C. Campbell at 312-707-7272.

 Bioenergetic Mechanisms Underlying Circadian Dietary Intervention

Principal Investigator: Joe Bass, MD, PhD

NIA, R01AG065988       

 

 

This proposal centers on the role of diet-induced stimulation of sympathetic nervous system catecholamines and uncoupling protein 1 in brown adipose tissue at different times-of-day.  Specifically, we will test the hypothesis that realignment of diet-induced thermogenesis rhythms and catecholamine biosynthesis with the light/dark cycle can be used as a countermeasure for high-fat diet induced obesity. A second major focus is to use NAD+ supplementation to mimic effects of time-restricted feeding and to dissect the role of the NAD+-SIRT1-CLOCK/BMAL1 pathway in circadian disruption with high-fat feeding.

 The Circadian System as a Neuronal Regulator of Feeding Time and Body Weight Setpoint

Principal Investigator: Joe Bass, MD, PhD

NIDDK, R01DK113011

This proposal seeks to define projection neurons within SCN that regulate AgRP/NpY cell types and to determine the identity of pacemaker neurons that both control weight gain with high-fat diet and influence the maintenance of reduced weight with hypocaloric feeding in animals that have become obese. 

 The Circadian System as a Neuronal Regulator of Feeding Time and Body Weight Setpoint

Principal Investigator: Joe Bass, MD, PhD

NIDDK, R01DK113011

This proposal seeks to define projection neurons within SCN that regulate AgRP/NpY cell types and to determine the identity of pacemaker neurons that both control weight gain with high-fat diet and influence the maintenance of reduced weight with hypocaloric feeding in animals that have become obese. 

 Integration of Feeding Time and Glucose Metabolism by the Circadian Gene Network

Principal Investigator: Joe Bass, MD, PhD

NIDDK, 2R01DK090625

Our long-term goal is to examine the integrated role of neural and pancreatic circadian transcription networks in the modulation of glucose and energy homeostasis. We will use inducible genetic and genomic approaches to define the chromatin regulatory mechanisms underlying clock control of b-cell glucose-stimulated insulin secretion and how the time of feeding influences meal-associated insulin secretagogues.

 

 Northwestern University Program in Endo Diabetes and Hormone Action

Principal Investigator: Joe Bass, MD, PhD

NIDDK, 2T32DK007169-38

 

The program is designed to provide training to predoctoral and postdoctoral trainees in the fundamental biology and integrative physiology of endocrinology, diabetes and metabolism in a disease-oriented environment.

 Effects of Spaceflight on Gastrointestinal Microbiota in Mice: Mechanisms and Impact on Multi-System Physiology

Principal Investigator: Fred Turek, PhD

NASA/ILSRA
NNX15AL05G

This project is intended to examine the potential role(s) of disruption of microbial communities in the gut (dysbiosis) in mammalian adjustment to the space environment. This study was approved for flight to ISS on SpaceX 14 and launched on 6/29/18. Onboard samples are expected to be analyzed in 2019.

 The Microbiome and Responsiveness to Stress: Countermeasure Strategies for Improving Resilience to Sleep and Circadian Disruption.

Principal Investigator: Fred Turek, PhD

ONR (DoD/MURI)
N00014-15-1-2809

We are testing operationally relevant combinations of behavioral and environmental stressors on the gut microbiome. We are examining how manipulating the gut microbiota impacts resilience to stressor exposure.

 Effects of Partial Gravity on Multi-system Mammalian Physiology: Microbiome and Related Systems

Principal Investigator: Martha Vitaterna

80NSSC 20K1519

This collaborative NASA-JAXA study on the International Space Station will use centrifugation-generated artificial gravity to examine the responses of multiple physiological systems (including the microbiome) to gravity levels ranging from microgravity to 1G.

 Leveraging a Unique existing Cohort to elucidate the Link between sleep and cardio-metabolic disease

Principal Investigator: Kristen Knutson, PhD

R01HL141881-02

This project will add measures to a cohort study in Brazil to examine detailed measures of sleep and their associations with biomarkers of cardiometabolic disease, and examine transcriptional and metabolic pathways as potential mechanisms to explain the effects of sleep on CMD development.

 An Epidemiologic Study of Disparities in Sleep and Cognition in Older Adults (DISCO)

Principal Investigator: Kristen Knutson, PhD, and Mercedes Carnethon, PhD

R01 AG059291-02

The specific aims of this award will be to set up the infrastructure and protocols for all methodologies and enroll 50-55 individuals from each of the three racial/groups (n=50) and conduct the study examinations.

 Determinants and Cardiovascular Consequences of Disparities in Sleep and Circadian Rhythms between Black and White Adults

Principal Investigator: Kristen Knutson, PhD, and Mercedes Carnethon, PhD

1R01HL152442-01 

Over one quarter of the adult population experiences sleep and circadian disturbances, characterized by inadequate sleep duration, poor sleep quality, the presence of sleep disorders and non-optimal timing of sleep. Non-white racial groups, Hispanic/Latinos and adults with fewer socioeconomic resources have a higher burden of sleep and circadian disturbances than their counterparts. Limitations of these prior studies include cross-sectional study designs, self-reported sleep, and incomplete assessment of sleep and circadian rhythms. The objective of our study is to identify a set of modifiable factors that explain racial disparities in sleep and circadian disturbances between black and white middle-aged adults. We will additionally test whether these sleep and circadian disparities account for disparities in blood pressure control. Our overall hypothesis is that black participants have a greater burden of adverse health behaviors, adiposity, psychological and social stressors, and environmental insults at the neighborhood and household level that contribute to more sleep and circadian disturbances as compared with whites.

 The ASCENT Study (Awareness and Self-Compassion Enhancing Narcolepsy Treatment)

Principal Investigator: Jason Ong, PhD 

The ASCENT Study aims to test the effectiveness of a mindfulness-based intervention (MBI) for improving health-related quality of life as a complementary practice to standard care for narcolepsy. This study is a feasibility trial in which 60 adults with narcolepsy will be randomized to receive either a 4-week (brief), 8-week (standard), or 12-week (extended) MBI. Each MBI will be delivered in small groups using a live videoconferencing platform and teaches mindfulness practices to help cope with narcolepsy symptoms. By developing a scalable mind-body intervention, this project can addresses a major research gap on improving psychosocial functioning in people with narcolepsy.

Learn More

For more information about this study, contact the study team at (312) 503-6627 or via email at matthew.schuiling@northwestern.edu.