- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02846077
Multi-scale Modeling of Sleep Behaviors in Social Networks
July 9, 2018 updated by: Elizabeth B. Klerman, Brigham and Women's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
729
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
College undergraduates
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
No intervention.
Observation only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timing of sleep and wake
Time Frame: Approximately one month
|
Timing of self-reported sleep onset and wake onset
|
Approximately one month
|
|
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)
|
Approximately one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood
Time Frame: Approximately one month
|
Self-reported mood using a linear non-numeric scale
|
Approximately one month
|
|
Activity levels
Time Frame: approximately one month
|
Activity levels collected every minute using a wrist-worn device
|
approximately one month
|
|
Light exposure levels
Time Frame: approximately one month
|
Light exposure levels collected every minute using a wrist-worn device
|
approximately one month
|
|
Food choice
Time Frame: approximately one month
|
Content of food
|
approximately one month
|
|
Circadian phase
Time Frame: one day
|
Calculated time of melatonin phase as a marker of circadian rhythms
|
one day
|
|
Electrodermal activity
Time Frame: approximately one month
|
Electrodermal activity as measured using a wrist-worn device
|
approximately one month
|
|
Timing of meals
Time Frame: approximately one month
|
Time meals are eaten
|
approximately one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fischer D, McHill AW, Sano A, Picard RW, Barger LK, Czeisler CA, Klerman EB, Phillips AJK. Irregular sleep and event schedules are associated with poorer self-reported well-being in US college students. Sleep. 2020 Jun 15;43(6):zsz300. doi: 10.1093/sleep/zsz300.
- McHill AW, Phillips AJ, Czeisler CA, Keating L, Yee K, Barger LK, Garaulet M, Scheer FA, Klerman EB. Later circadian timing of food intake is associated with increased body fat. Am J Clin Nutr. 2017 Nov;106(5):1213-1219. doi: 10.3945/ajcn.117.161588. Epub 2017 Sep 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2013
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
July 15, 2016
First Submitted That Met QC Criteria
July 24, 2016
First Posted (Estimate)
July 27, 2016
Study Record Updates
Last Update Posted (Actual)
July 11, 2018
Last Update Submitted That Met QC Criteria
July 9, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- BrighamHospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.