Sleep Wake DisordersNCT03956745
Biomarkers for Circadian Timing in Healthy Adults
An observational study of Sleep Wake Disorders and Sleep Disorders, Circadian Rhythm, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Sleep Disorders, Intrinsic
- What is being tested?
- sleep-wake timing and constant routine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be recruited from the surrounding community.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Hearing impairment
- Drug or Alcohol dependency
- Pregnant, intending to become pregnant, or recently pregnant (last 6 months)
- Breastfeeding within the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Proteomic and Transcriptomic Biomarkers of Circadian Timing
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.
- Conditions
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Sleep Disorders, Intrinsic, Advanced Sleep Phase Syndrome (ASPS), Advanced Sleep Phase Syndrome, Advanced Sleep Phase
- Being tested
- sleep-wake timing, constant routine
- Keywords
- Sleep, Aging, Circadian Rhythms, Circadian Rhythm Disorders
- Medical subject headings
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Sleep Disorders, Intrinsic, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep-wake timingBehavioural
Study participants will have one inverted day when they are scheduled to sleep ~12h opposite their usual sleep time.
constant routineBehavioural
Study participants will spend ~28-50 hours awake, inactive, sitting in bed, in constant lighting and temperature.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Inverted Day (Study days 6-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Jun 2021
- Primary completion31 Dec 2023
- Study completion30 Apr 2025
Why it stopped: Grant funding supporting the study ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Wake DisordersStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Jeanne Duffy, Brigham and Women's Hospital
- Investigators
- Jeanne F Duffy, MBA, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956745
- Sponsor's protocol ID
- 2019-P-001247
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2019
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic and Transcriptomic Biomarkers of Circadian Timing
- ClinicalTrials.gov ID
- NCT03956745
- Acronym / sponsor ID
- 2019-P-001247
- Conditions
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Sleep Disorders, Intrinsic, Advanced Sleep Phase Syndrome (ASPS), Advanced Sleep Phase Syndrome, Advanced Sleep Phase
- Keywords
- Sleep, Aging, Circadian Rhythms, Circadian Rhythm Disorders
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Grant funding supporting the study ended.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Stanford University, Charite University, Berlin, Germany
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be recruited from the surrounding community.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep-wake timingStudy participants will have one inverted day when they are scheduled to sleep ~12h opposite their usual sleep time. | Behavioural | – |
| constant routineStudy participants will spend ~28-50 hours awake, inactive, sitting in bed, in constant lighting and temperature. | Behavioural | – |
Primary outcome
Circadian Phase Timing by BodyTime Assay - Baseline Segment
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study was stopped early (reason given: Grant funding supporting the study ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne F Duffy, MBA, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Wake Disorders and Sleep Disorders, Circadian Rhythm, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Grant funding supporting the study ended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian Phase Timing by BodyTime Assay - Baseline Segment (time frame: Baseline Segment (Study day 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.