CClinicalTrials.gg
TerminatedNCT03956745Updated Aug 3, 2025

Biomarkers for Circadian Timing in Healthy Adults

An observational study in Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm and Sleep Disorders, Intrinsic, sponsored by Brigham and Women's Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Brigham and Women's Hospital · Observational

Why this study was terminated
Grant funding supporting the study ended.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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

Keywords

  • Sleep
  • Aging
  • Circadian Rhythms
  • Circadian Rhythm Disorders
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's enrollment of 15 is below the median of 114 across 215 observational studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers will be recruited from the surrounding community.

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline Segment (Study day 3)

  2. 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.

    Time frame: During Constant Routine (Study days 4-5)

  3. 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.

    Time frame: Inverted Day (Study days 6-7)

07

Study locations

1 site
  • Brigham & Women's Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03956745
Lead sponsor
Brigham and Women's Hospital
Collaborators
Stanford University, Charite University, Berlin, Germany
Responsible party
Jeanne Duffy (Principal Investigator, Brigham and Women's Hospital) — Principal investigator
First posted
May 21, 2019
Start date
Jun 1, 2021
Primary completion
Dec 31, 2023
Completion
Apr 30, 2025
Last update
Aug 3, 2025

Study contacts

Jeanne F Duffy, MBA, PhD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion