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出境医 / 临床实验 / Biomarkers for Circadian Timing in Healthy Adults

Biomarkers for Circadian Timing in Healthy Adults

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
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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Proteomic and Transcriptomic Biomarkers of Circadian Timing
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Circadian Phase Timing by BodyTime Assay - Baseline Segment [ Time Frame: 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.

  2. Circadian Phase Timing by BodyTime Assay - Constant Routine [ Time Frame: 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.

  3. Circadian Phase Timing by BodyTime Assay - Inverted Day [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
A genetic blood sample will be collected from each participant. Candidate circadian or sleep genes will be directly sequenced in order to identify polymorphisms or mutations that associate with circadian or sleep phenotypes. Researchers may also conduct genome wide analysis on the DNA sample.

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 23, 2019
First Posted Date May 21, 2019
Last Update Posted Date March 11, 2021
Estimated Study Start Date April 2021
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2019)
  • Circadian Phase Timing by BodyTime Assay - Baseline Segment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers for Circadian Timing in Healthy Adults
Official Title Proteomic and Transcriptomic Biomarkers of Circadian Timing
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
A genetic blood sample will be collected from each participant. Candidate circadian or sleep genes will be directly sequenced in order to identify polymorphisms or mutations that associate with circadian or sleep phenotypes. Researchers may also conduct genome wide analysis on the DNA sample.
Sampling Method Non-Probability Sample
Study Population Healthy volunteers will be recruited from the surrounding community.
Condition
  • 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
Intervention
  • Behavioral: sleep-wake timing
    Study participants will have one inverted day when they are scheduled to sleep ~12h opposite their usual sleep time.
  • Behavioral: constant routine
    Study participants will spend ~28-50 hours awake, inactive, sitting in bed, in constant lighting and temperature.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 16, 2019) 		100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Research Study Coordinator 617-525-8813 BodyClockStudy@research.bwh.harvard.edu
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03956745
Other Study ID Numbers 2019-P-001247
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Jeanne Duffy, Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
Collaborators
  • Stanford University
  • Charite University, Berlin, Germany
Investigators
Principal Investigator: Jeanne F Duffy, MBA, PhD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date March 2021

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