Identification of Novel Circadian Biomarkers

Completed

Conditions studied: Circadian Rhythm Disorders

In brief

Circadian clocks are not only found in discrete areas of the brain, but are found in virtually every organ in our bodies, including the heart, lungs and immune system. Disruptions in circadian clocks, or chronopathology, may underlie various forms of cardiovascular, pulmonary, and metabolic disorders. Over the past two decades, molecular geneticists have "cracked" the clock to reveal its core biochemical mechanisms evident in organisms from fruit flies to humans. These mechanistic insights have led to the discovery of links between clock function and an ever-expanding array of prevalent diseases, including heart, lung, metabolic and sleep disorders. Yet the prevalence of circadian disruption in these patient populations is unclear because current tests are not easily applied in clinical settings or have yet to be developed. Here the investigators exploit our newfound understanding of clock mechanisms and the development of new genomic technologies to identify novel complements of clock-regulated genes ("signatures") that will reveal the state of the internal biological clock. This approach will allow us to take a genomic snapshot of clock status from a single blood draw, substantially easing the diagnosis of these individuals with evidence of circadian disruption or misalignment, i.e., chronopathology.

Key facts

Study ID

NCT02291003

Run by

Northwestern University

People needed

3

Starts

2015-01-29

Expected to finish

2017-09-30

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy controls
• Age 18-60
• Intermediate circadian chronotype as determined by the Horne-Ostberg and Munich questionnaire
• Habitual sleep start times between 9:30pm and 1am
• Habitual sleep duration of 6-9 hours

You may not qualify if…

• History or current Diagnostic and Statistical Manual-V major psychiatric disorder
• Use of psychoactive medications
• Beck Depression inventory ≥ 16 indicating possible depression
• A history or current diagnosis of a primary sleep disorder (insomnia, sleep apnea, circadian rhythm sleep disorder, restless legs)
• Shift work or other types of self-imposed irregular sleep/wake cycles
• History of, or concurrent unstable or serious medical illness
• Allergy to heparin
• Blindness or other visual impairment other than glasses

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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