Clinical trial NCT03956745: Biomarkers for Circadian Timing in Healthy Adults
Official title: Proteomic and Transcriptomic Biomarkers of Circadian Timing
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Keywords: Sleep
Aging
Circadian Rhythms
Circadian Rhythm Disorders
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Charite University, Berlin, Germany
First posted: 2019-05-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers will be recruited from the surrounding community.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Circadian Phase Timing by BodyTime Assay - Baseline Segment
timeFrame: Baseline Segment (Study day 3)
measure: Circadian Phase Timing by BodyTime Assay - Constant Routine
timeFrame: During Constant Routine (Study days 4-5)
measure: Circadian Phase Timing by BodyTime Assay - Inverted Day
timeFrame: Inverted Day (Study days 6-7)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeanne F Duffy, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
References: