Skip to content

Biomarkers for Circadian Timing in Healthy Adults

Proteomic and Transcriptomic Biomarkers of Circadian Timing

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03956745
Enrollment
15
Registered
2019-05-21
Start date
2021-06-01
Completion date
2025-04-30
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sleep, Aging, Circadian Rhythms, Circadian Rhythm Disorders

Brief summary

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

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.

Interventions

BEHAVIORALsleep-wake timing

Study participants will have one inverted day when they are scheduled to sleep \ 12h opposite their usual sleep time.

BEHAVIORALconstant routine

Study participants will spend \ 28-50 hours awake, inactive, sitting in bed, in constant lighting and temperature.

Sponsors

Stanford University
CollaboratorOTHER
Charite University, Berlin, Germany
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Circadian Phase Timing by BodyTime Assay - Baseline SegmentBaseline 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 RoutineDuring 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 DayInverted 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026