Trials / Terminated
TerminatedNCT03956745
Biomarkers for Circadian Timing in Healthy Adults
Proteomic and Transcriptomic Biomarkers of Circadian Timing
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2023-12-31
- Completion
- 2025-04-30
- First posted
- 2019-05-21
- Last updated
- 2025-08-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03956745. Inclusion in this directory is not an endorsement.