Biomarkers for Circadian Timing in Healthy Adults

NCT ID: NCT03956745

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-04-30

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

sleep-wake timing

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

Intervention Type: BEHAVIORAL

constant routine

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Duffy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanne F Duffy, MBA, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham & Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2019-P-001247

Identifier Type: -

Identifier Source: org_study_id