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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02846077
Other study ID # BrighamHospital
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2013
Est. completion date June 2018

Study information

Verified date July 2018
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 729
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention. Observation only
No intervention. Observation only

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Brigham and Women's Hospital Harvard University, Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Timing of sleep and wake Timing of self-reported sleep onset and wake onset Approximately one month
Primary Timing of phone use (e.g., mobile phone calls, text messages, applications and internet use) Timing of phone use (e.g, mobile phone calls, text messages, applications and internet use) Approximately one month
Secondary Mood Self-reported mood using a linear non-numeric scale Approximately one month
Secondary Activity levels Activity levels collected every minute using a wrist-worn device approximately one month
Secondary Light exposure levels Light exposure levels collected every minute using a wrist-worn device approximately one month
Secondary Food choice Content of food approximately one month
Secondary Circadian phase Calculated time of melatonin phase as a marker of circadian rhythms one day
Secondary Electrodermal activity Electrodermal activity as measured using a wrist-worn device approximately one month
Secondary Timing of meals Time meals are eaten approximately one month
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