Biomarkers for Circadian Timing in Healthy Adults
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Primary Outcome Measures
- Circadian Phase Timing by BodyTime Assay - Baseline Segment [Baseline Segment (Study day 3)]
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.
- Circadian Phase Timing by BodyTime Assay - Constant Routine [During Constant Routine (Study days 4-5)]
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.
- Circadian Phase Timing by BodyTime Assay - Inverted Day [Inverted Day (Study days 6-7)]
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.
Healthy adults with conventional and regular sleep-wake timing
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
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
Drug or Alcohol dependency
Pregnant, intending to become pregnant, or recently pregnant (last 6 months)
Breastfeeding within the past 6 months
Contacts and Locations
|1||Brigham & Women's Hospital||Boston||Massachusetts||United States||02115|
Sponsors and Collaborators
- Brigham and Women's Hospital
- Stanford University
- Charite University, Berlin, Germany
- Principal Investigator: Jeanne F Duffy, MBA, PhD, Brigham and Women's Hospital
Study Documents (Full-Text)None provided.