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Participate in a Research Study

The Center for Circadian & Sleep Medicine is focused on clinical research. Learn more about our trials and participation opportunities via the search results for Northwestern Neurology on clinicaltrials.gov. Below is a selected list of our current active protocols.

Feinberg Clinical Trials

Scientists at the medical school are conducting hundreds of clinical trials daily. Learn more about all our work via the Feinberg Office of Research Clinical Trials page. Search below for trials by disease or condition.

Trials

Evaluating the Circadian Response to Light in Delayed Sleep-Wake Phase Disorder

This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity …
This study is looking at factors that contribute to the timing of sleep. Interested subjects will undergo screening to determine their sleep-wake habits, then will have an eye test and a blood draw. Participation will involve 2 outpatient visits, separated by up to 3 weeks of sleep-wake activity monitoring.
Individuals with delayed sleep-wake phase disorder and healthy controls
Abbott, Sabra MargaretAbbott, Sabra Margaret
  • Map it 201 E. Huron St.
    Chicago, IL
STU00203647
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Alterations of Sleep and Circadian Timing in Aging

Purpose: 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 …
Purpose: 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 55-75 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.
Zee, Phyllis CZee, Phyllis C
NCT03490825 STU00206014
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Strengthening Circadian Signals to Enhance Cardiometabolic Functions

Purpose: 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 …
Purpose: 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 40-54 who have no diagnosis of diabetes or sleep disorders may be eligible for this study.
Zee, Phyllis CZee, Phyllis C
  • Map it 675 N. St. Clair St. Suite 20 100
    Chicago, IL
NCT03490864 STU00206038
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The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients with Heart Failure and Central Sleep Apnea.

The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).…
The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).

Inclusion Criteria:

  • Aged ≥ 21 years at the date of consent.
  • History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 45% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
  • Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas) and a central AHI ≥ 10/h or obstructive apnea index (OAI) < 20%
  • New York Heart Association (NYHA) Class III or IV, or NYHA Class II with ≥ 1 hospitalization for HF in the last 24 months.
  • Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization.
  • In the investigator's opinion, willing and able to comply with all study requirements
  • Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent

Exclusion Criteria:

  • Current positive airway pressure use of diagnosis of Obstructive Sleep Apnea (OSA).
  • Oxygen saturation < 90% at rest during the day.
  • Oxygen saturation < 88% for > 5 continuous minutes during sleep unaccompanied by respiratory events.
  • Chronic daytime or nighttime use of supplemental oxygen.
  • Current smoker or bed partner that smokes in the bedroom.
  • Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
  • Body mass index (BMI) > 35 kg/m2.
  • Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
  • Transient ischemic attack or stroke within the previous 3 months.
  • Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
  • Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial
  • Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
  • End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
  • Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
  • Life expectancy < 1 year for diseases unrelated to chronic HF.
  • Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.
Zee, Phyllis CZee, Phyllis C
  • Map it 676 N. Saint Clair St. Seventh Floor, Suite 701
    Chicago, IL
  • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
    Chicago, IL
NCT03745898 STU00209337
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A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)

The purpose of this study is to evaluate the effect of aninvestigational drug called tasimelteon on the sleep-wake cycle of patientswith Delayed Sleep-Wake Phase Disorder (DSWPD) and to assess the safety oftasimelteon. Participants in this study will randomly be assigned totasimelteon or placebo, to take over a period …

The purpose of this study is to evaluate the effect of aninvestigational drug called tasimelteon on the sleep-wake cycle of patientswith Delayed Sleep-Wake Phase Disorder (DSWPD) and to assess the safety oftasimelteon. Participants in this study will randomly be assigned totasimelteon or placebo, to take over a period of 35 days. During this time,participants will be required to go to bed at certain fixed times and keep anelectronic daily sleep diary. Additionally, there will be 4 visits to yourstudy doctor's clinic, where you will be assessed for eligibility and safety.At the clinic, your study doctor will perform a physical examination, blooddraws, heart tests, questionnaires, and test your urine for drugs and alcohol.You will not be charged for any of these procedures and you may be compensatedfor your time.

If you complete the initial 35 days of the study, you willhave the option of receiving treatment with tasimelteon for up to 11 monthsafter. No matter which treatment you were randomly assigned during the first 35days, tasimelteon or placebo, you will receive tasimelteon during theadditional 11 months, if you choose to continue. During those 11 months, therewill be 4 additional visits to your study doctor's clinic (spaced 60-90 daysapart) to assess your health and safety.

  • Inclusion Criteria:

    • Ability and acceptance to provide written informed consent of the participant or legal guardian. Participants ≥ 16 and < 18 years of age will also need to provide written assent.
    • A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
    • Men or women between 16 - 65 years, inclusive.
    • Body Mass Index (BMI) of ≥ 18 and ≤ 30 kg/m^2.

  • Exclusion Criteria:
    • History of psychiatric disorders within 12 months.
    • Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
    • Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
    • A positive test for substances of abuse
Zee, Phyllis CZee, Phyllis C
  • Map it 676 N. Saint Clair St. Seventh Floor, Suite 701
    Chicago, IL
  • Map it 259 E. Erie St. Lavin Pavillion, Suite 19 100
    Chicago, IL
NCT04652882 STU00213922
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