Biomarkers for Circadian Timing in Healthy Adults

Active, not recruiting

• Conditions: Sleep Disorders, Circadian Rhythm; Delayed Sleep Phase Syndrome; Non-24 Hour Sleep-Wake Disorder; Sleep Disorders, Intrinsic; Advanced Sleep Phase Syndrome (ASPS); Irregular Sleep-Wake Syndrome; Shift-Work Sleep Disorder; Delayed Phase Sleep Syndrome; Sleep Wake Disorders; Advanced Sleep Phase

• Registration Number: NCT03956745
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-21
• Study Start: 2021-06-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circadian Phase Timing by BodyTime Assay - Constant Routine	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 - Baseline Segment	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 - Inverted Day	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.

Trial Locations

Locations (1)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States