Biomarkers for Circadian Timing in Healthy Adults

Study Overview
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Brief Summary
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Study investigators want to learn more about the underlying biological clock and to see if the timing of that clock can be estimated from a single blood sample.

Detailed Description
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There is an urgent need for a practical way to assess circadian timing accurately in both general and sleep medicine. The study is designed to assess the levels of different biomarkers in the blood taken from frequent samples across three separate sleep-wake conditions - Conventional/Normal sleep-wake conditions (baseline), extended wake/acute sleep deprivation (constant routine), and during irregular sleep-wake conditions (inverted day). Participants will be asked to complete medical, psychological, and sleep-wake evaluations prior to the study. Upon completion of screening, if eligible, participants will stay 7 consecutive days and nights in the sleep research laboratory within the hospital.

Official Title
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Proteomic and Transcriptomic Biomarkers of Circadian Timing

Conditions
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Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Sleep Disorders, Intrinsic, Advanced Sleep Phase Syndrome (ASPS), Advanced Sleep Phase Syndrome, Advanced Sleep Phase, Delayed Sleep Phase, Delayed Sleep Phase Syndrome, Non-24 Hour Sleep-Wake Disorder, Irregular Sleep-Wake Syndrome, Shift-Work Sleep Disorder, Shift Work Type Circadian Rhythm Sleep Disorder, Delayed Phase Sleep Syndrome

Intervention / Treatment
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* Behavioral: sleep-wake timing
* Behavioral: constant routine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults with conventional and regular sleep-wake timing Non-smokers Able to spend 7 consecutive days/nights in the laboratory Willing to abstain from use of caffeine, nicotine, and alcohol during pre-study and study periods Exclusion Criteria: History of neurological or psychiatric disorder History of sleep disorder or regular use of sleep-promoting medication Current prescription, herbal, or over-the-counter medication use Traveling across 2 or more time zones within the past 3 months Donating blood within the past 8 weeks Worked night or rotating shiftwork within the past 3 years Hearing impairment Drug or Alcohol dependency Pregnant, intending to become pregnant, or recently pregnant (last 6 months) Breastfeeding within the past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: sleep-wake timing|Study participants will have one inverted day when they are scheduled to sleep  12h opposite their usual sleep time.|
|Behavioral: constant routine|Study participants will spend  28-50 hours awake, inactive, sitting in bed, in constant lighting and temperature.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian Phase Timing by BodyTime Assay - Baseline Segment | Circadian phase will be predicted by the BodyTime assay during the baseline segment (study day 3) and will be compared to conventional phase assessment methods. | Baseline Segment (Study day 3) | 
| Circadian Phase Timing by BodyTime Assay - Constant Routine | Circadian phase will be predicted by the BodyTime assay during the Constant Routine (study days 4-5) and will be compared to conventional phase assessment methods. | During Constant Routine (Study days 4-5) | 
| Circadian Phase Timing by BodyTime Assay - Inverted Day | Circadian phase will be predicted by the BodyTime assay during the Inverted Day (study days 6-7) and will be compared to conventional phase assessment methods. | Inverted Day (Study days 6-7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Aging, Circadian Rhythms, Circadian Rhythm Disorders