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Multi-scale Modeling of Sleep Behaviors in Social Networks

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ClinicalTrials.gov Identifier: NCT02846077
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
Massachusetts Institute of Technology
Harvard University
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital

Tracking Information
First Submitted Date July 15, 2016
First Posted Date July 27, 2016
Last Update Posted Date July 11, 2018
Actual Study Start Date September 2013
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2016)
  • Timing of sleep and wake [ Time Frame: Approximately one month ]
    Timing of self-reported sleep onset and wake onset
  • Timing of phone use (e.g., mobile phone calls, text messages, applications and internet use) [ Time Frame: Approximately one month ]
    Timing of phone use (e.g, mobile phone calls, text messages, applications and internet use)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 24, 2016)
  • Mood [ Time Frame: Approximately one month ]
    Self-reported mood using a linear non-numeric scale
  • Activity levels [ Time Frame: approximately one month ]
    Activity levels collected every minute using a wrist-worn device
  • Light exposure levels [ Time Frame: approximately one month ]
    Light exposure levels collected every minute using a wrist-worn device
  • Food choice [ Time Frame: approximately one month ]
    Content of food
  • Circadian phase [ Time Frame: one day ]
    Calculated time of melatonin phase as a marker of circadian rhythms
  • Electrodermal activity [ Time Frame: approximately one month ]
    Electrodermal activity as measured using a wrist-worn device
  • Timing of meals [ Time Frame: approximately one month ]
    Time meals are eaten
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-scale Modeling of Sleep Behaviors in Social Networks
Official Title Multi-scale Modeling of Sleep Behaviors in Social Networks
Brief Summary The project is designed to document in college undergraduates the relationships among sleep/wake timing and duration, use of mobile phones and other electronic devices, food timing and content, self-reported mood and physiological measures.
Detailed Description College undergraduates are studied in cohorts of ~ 50 in fall or spring semesters. They complete diaries once in the morning and once in the evening about sleep/wake timing, timing of social and school activities, and mood. They wear physiological sensors. They install (1) an application on their mobile phone that tracks timing, duration and de-identified sender/recipient of phone calls and text messages, use of internet or apps (but not the content or names of those internet sites and apps) and (2) meal content and timing. They also spend at least one overnight session providing saliva samples for later assay for hormones.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Saliva
Sampling Method Non-Probability Sample
Study Population College undergraduates
Condition Healthy Volunteers
Intervention Other: No intervention. Observation only
No intervention. Observation only
Study Groups/Cohorts College students
College students will be monitored and will complete online surveys, install apps on their mobile phones, wear physiological sensors and provide saliva samples for later assay.
Intervention: Other: No intervention. Observation only
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 9, 2018)
729
Original Estimated Enrollment
 (submitted: July 24, 2016)
400
Actual Study Completion Date June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • undergraduate at institution at which we have permission to perform study
  • owning a mobile device on which the phone app can be installed
  • ability to wear the wrist-worn sensors

Exclusion Criteria:

  • no travel outside one time zone starting approximately 2 weeks before monitoring begins through end of approximately one month of monitoring.
  • participation in a prior group studied
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02846077
Other Study ID Numbers BrighamHospital
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Elizabeth B. Klerman, Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
Collaborators
  • Massachusetts Institute of Technology
  • Harvard University
Investigators
Principal Investigator: Elizabeth B Klerman, MD PhD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date July 2018