Proteomic and Transcriptomic Biomarkers of Circadian Timing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Circadian Phase Timing by BodyTime Assay - Constant Routine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Circadian Phase Timing by BodyTime Assay - Constant Routine
时间窗: 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 - Baseline Segment
时间窗: 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 - Inverted Day
时间窗: 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.
次要结局
未报告次要终点
研究者
Jeanne Duffy
Principal Investigator
Brigham and Women's Hospital