Biomarkers for Circadian Timing in Healthy Adults

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03956745

Collaborator

Stanford University (Other), Charite University, Berlin, Germany (Other)

100

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Proteomic and Transcriptomic Biomarkers of Circadian Timing

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

Circadian Phase Timing by BodyTime Assay - Baseline Segment [Baseline Segment (Study day 3)]
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.
Circadian Phase Timing by BodyTime Assay - Constant Routine [During Constant Routine (Study days 4-5)]
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.
Circadian Phase Timing by BodyTime Assay - Inverted Day [Inverted Day (Study days 6-7)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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