Biomarkers for Circadian Timing in Healthy Adults

Proteomic and Transcriptomic Biomarkers of Circadian Timing

Sponsors

Lead Sponsor: Brigham and Women's Hospital

Collaborator: Stanford University
Charite University, Berlin, Germany

Source 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.

Overall Status Not yet recruiting
Start Date September 1, 2020
Completion Date June 2023
Primary Completion Date June 2023
Study Type Observational
Primary Outcome
Measure Time Frame
Circadian Phase Timing by BodyTime Assay - Baseline Segment Baseline Segment (Study day 3)
Circadian Phase Timing by BodyTime Assay - Constant Routine During Constant Routine (Study days 4-5)
Circadian Phase Timing by BodyTime Assay - Inverted Day Inverted Day (Study days 6-7)
Enrollment 100
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: sleep-wake timing

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

Intervention Type: Behavioral

Intervention Name: constant routine

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

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jeanne F Duffy, MBA, PhD Principal Investigator Brigham and Women's Hospital
Overall Contact

Last Name: Research Study Coordinator

Phone: 617-525-8813

Email: [email protected]

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Brigham and Women's Hospital

Investigator Full Name: Jeanne Duffy

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov