Healthy VolunteersNCT02846077
Multi-scale Modeling of Sleep Behaviors in Social Networks
An observational study of Healthy Volunteers, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 729 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: College undergraduates
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- No intervention. Observation only
- Keywords
- sleep, social networks, undergraduates, mood, circadian rhythms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Observation onlyOther
No intervention. Observation only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention. Observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of sleep and wake
Timing of self-reported sleep onset and wake onset
Measured: Approximately one month
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)
Measured: Approximately one month
Secondary outcomes (7)
Mood
Self-reported mood using a linear non-numeric scale
Measured: Approximately one month
Activity levels
Activity levels collected every minute using a wrist-worn device
Measured: approximately one month
Light exposure levels
Light exposure levels collected every minute using a wrist-worn device
Measured: approximately one month
Food choice
Content of food
Measured: approximately one month
Circadian phase
Calculated time of melatonin phase as a marker of circadian rhythms
Measured: one day
Electrodermal activity
Electrodermal activity as measured using a wrist-worn device
Measured: approximately one month
Timing of meals
Time meals are eaten
Measured: approximately one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Harvard University
- Responsible party
- Principal investigator, Elizabeth B. Klerman, Brigham and Women's Hospital
- Investigators
- Elizabeth B Klerman, MD PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846077
- Sponsor's protocol ID
- BrighamHospital
- Status last verified
- Jul 2018
- First submitted
- 15 Jul 2016
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lu S, Stone JE, Klerman EB, McHill AW, Barger LK, Robbins R, Fischer D, Sano A, Czeisler CA, Rajaratnam SMW, Phillips AJK. The organization of sleep-wake patterns around daily schedules in college students. Sleep. 2024 Sep 9;47(9):zsad278. doi: 10.1093/sleep/zsad278.
PubMed 37930792Khalid M, Sano A. Exploiting social graph networks for emotion prediction. Sci Rep. 2023 Apr 13;13(1):6069. doi: 10.1038/s41598-023-32825-9.
PubMed 37055459Fischer 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.
PubMed 31837266McHill 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.
PubMed 28877894
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-scale Modeling of Sleep Behaviors in Social Networks
- ClinicalTrials.gov ID
- NCT02846077
- Acronym / sponsor ID
- BrighamHospital
- Conditions
- Healthy Volunteers
- Keywords
- sleep, social networks, undergraduates, mood, circadian rhythms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 729 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Harvard University
- Study start
- Sep 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| College students | – | Other: No intervention. Observation onlyCollege 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- College undergraduates
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. Observation onlyNo intervention. Observation only | Other | College students |
Primary outcome
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)
7 secondary outcomes
Mood
Time frame: Approximately one month
Activity levels
Time frame: approximately one month
Light exposure levels
Time frame: approximately one month
Food choice
Time frame: approximately one month
Circadian phase
Time frame: one day
Electrodermal activity
Time frame: approximately one month
Timing of meals
Time frame: approximately one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Derived from this study: PubMed 37930792Lu S, Stone JE, Klerman EB, McHill AW, Barger LK, Robbins R, Fischer D, Sano A, Czeisler CA, Rajaratnam SMW, Phillips AJK. The organization of sleep-wake patterns around daily schedules in college students. Sleep. 2024 Sep 9;47(9):zsad278. doi: 10.1093/sleep/zsad278.
- Derived from this study: PubMed 37055459Khalid M, Sano A. Exploiting social graph networks for emotion prediction. Sci Rep. 2023 Apr 13;13(1):6069. doi: 10.1038/s41598-023-32825-9.
- Derived from this study: PubMed 31837266Fischer 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.
- Derived from this study: PubMed 28877894McHill 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.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth B Klerman, MD PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of sleep and wake (time frame: Approximately one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846077, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.