Clinical Trials Directory

Trials / Terminated

TerminatedNCT03956745

Biomarkers for Circadian Timing in Healthy Adults

Proteomic and Transcriptomic Biomarkers of Circadian Timing

Status
Terminated
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALsleep-wake timingStudy participants will have one inverted day when they are scheduled to sleep \~12h opposite their usual sleep time.
BEHAVIORALconstant routineStudy participants will spend \~28-50 hours awake, inactive, sitting in bed, in constant lighting and temperature.

Timeline

Start date
2021-06-01
Primary completion
2023-12-31
Completion
2025-04-30
First posted
2019-05-21
Last updated
2025-08-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03956745. Inclusion in this directory is not an endorsement.