Biomarkers for Circadian Timing in Healthy Adults

Sleep Disorders, Circadian Rhythm Clinical Trial

Official title:

Proteomic and Transcriptomic Biomarkers of Circadian Timing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03956745
• Other study ID #: 2019-P-001247
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: Research Study Coordinator
• Phone: 617-525-8813
• Email: BodyClockStudy[@]research.bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• sleep-wake timing
Study participants will have one inverted day when they are scheduled to sleep ~12h opposite their usual sleep time.
• constant routine
Study participants will spend ~28-50 hours awake, inactive, sitting in bed, in constant lighting and temperature.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Charite University, Berlin, Germany, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)