Sleep Disorders, Circadian Rhythm Clinical Trial
Official title:
Proteomic and Transcriptomic Biomarkers of Circadian Timing
NCT number | NCT03956745 |
Other study ID # | 2019-P-001247 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | May 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham & Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Charite University, Berlin, Germany, Stanford University |
United States,
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) |
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