Biomarkers for Circadian Timing in Healthy Adults

Brigham and Women's Hospital15 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Sleep Wake Disorders Sleep Disorders, Circadian Rhythm Sleep Disorders, Intrinsic Advanced Sleep Phase Syndrome (ASPS)Advanced Sleep Phase Syndrome

Interventions

sleep-wake timingBEHAVIORAL

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

constant routineBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

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)

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)