Biomarkers for Circadian Timing in Healthy Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorders, Intrinsic; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Advanced Sleep Phase Syndrome (ASPS); Delayed Sleep Phase Syndrome; Shift-Work Sleep Disorder; Delayed Sleep Phase; Non-24 Hour Sleep-Wake Disorder; Advanced Sleep Phase Syndrome; Advanced Sleep Phase; Irregular Sleep-Wake Syndrome; Shift Work Type Circadian Rhythm Sleep Disorder; Delayed Phase Sleep Syndrome
• Intervention / Treatment: Behavioral: sleep-wake timing; Behavioral: constant routine

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Research Study Coordinator; Phone Number: 617-525-8813; Email: BodyClockStudy@research.bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital
      • Contact: Mia Friedman; Phone Number: 617-525-8813; Email: bodyclockstudy@research.bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited from the surrounding community.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Inverted Day (Study days 6-7)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Charite University, Berlin, Germany; Stanford University
• Investigators: Principal Investigator: Jeanne F Duffy, MBA, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; Aging; Circadian Rhythms; Circadian Rhythm Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Disease; Occupational Diseases; Chronobiology Disorders; Syndrome; Sleep Wake Disorders; Parasomnias; Sleep Disorders, Intrinsic; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 2019-P-001247

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No