Healthy Volunteers Clinical Trial
Official title:
Multi-scale Modeling of Sleep Behaviors in Social Networks
| 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 |
| Verified date | July 2018 |
| Source | Brigham and Women's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Brigham and Women's Hospital | Harvard University, Massachusetts Institute of Technology |
United States,
| 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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