Biomarkers for Circadian Timing in Healthy Adults

NCT03956745 | Terminated

• 1 other identifier: 2019-P-001247
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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)

Interventions

sleep-wake timing BEHAVIORAL

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

constant routine BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited from the surrounding community.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Stanford University: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A genetic blood sample will be collected from each participant. Candidate circadian or sleep genes will be directly sequenced in order to identify polymorphisms or mutations that associate with circadian or sleep phenotypes. Researchers may also conduct genome wide analysis on the DNA sample.

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Sleep Disorders, Intrinsic; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Dyssomnias; Occupational Diseases

Study Officials

• Jeanne F Duffy, MBA, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 21, 2019
• Study Start: June 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

US (1)