Preventative HealthFRoSHNCT03214523
Freshman Sleep and Health Project
A study testing Sleep Education in people with Preventative Health and Sleep, run by University of California, San Diego at 1 site in United States.
Trial summary
Sleep is a clearly necessary neurobiologic process that influences innumerable aspects of basic daily functions, physical health, and mental well-being. Recent literature shows that college students across the country are experiencing high rates of sleep deprivation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preventative Health, Sleep, Weight
- What is being tested?
- Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2017to 31 Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- Incoming UCSD freshman
Who cannot join
- Under 18 years of age
- Not living on UCSD campus
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92121
About this study
Sleep is a clearly necessary neurobiologic process that influences innumerable aspects of basic daily functions, physical health, and mental well-being. Recent literature shows that college students across the country are experiencing high rates of sleep deprivation. Interestingly, some recent studies have implicated this sleep loss in contributing to weight gain that occurs in the first year of college, also known as the "freshman fifteen." Rates of depression and other mental health issues, which are closely connected to sleep disturbances, are also on the rise in college campuses. The majority of the sleep data obtained in this population has been via questionnaires and self report, and the studies usually include college students at all seniority levels (e.g., freshmen, sophomores, seniors). Here, the investigators outline a novel study investigating how sleep time changes in college freshman, and how it relates to multiple different aspects of their health and functioning over the course of one quarter.
As technology has advanced, the ability to easily obtain objective measurements of different health parameters has increased dramatically. The investigators plan to use wireless actigraphy devices to measure sleep over a baseline seven day period in college-bound UCSD students prior to matriculation, and for 2 additional seven day periods during the first quarter of college. To the knowledge of the investigators, this is the first study to directly measure sleep time in college freshman in their normal environment. Effects of sleep time loss will be evaluated through multiple different metrics of physical and mental health. Given the recent link between sleep disturbances and weight gain in college freshman, the investigators will plan to measure weight changes prior to entering college and at two different time points through the first quarter. The investigators will use the PSQ-9 and GAD7 batteries as measures of mental health, obtained at the same time points as the sleep and weight information. As one of the primary consequences of sleep deprivation is on neurocognition in the daytime, the investigators plan to measure vigilant attention using psychomotor vigilance testing (PVT) as well. Screen time use has recently been targeted as a possible contributor to sleep loss in adolescents as well as adults and is something the investigators will attempt to measure as well using a smartphone application. Finally, this project will test the efficacy of a one hour sleep education intervention on improving total sleep time.
To the knowledge of the investigators, no other studies have closely examined how total sleep time changes during the first year of college in freshman in relationship to weight and mental health parameters, nor has PVT been done in this context. Additionally, with the increasing concerns regarding screen time use in adolescents and young adults, this study provides prime opportunity to examine this issue in the context of sleep.
- Conditions
- Preventative Health, Sleep, Weight
- Being tested
- Sleep Education
- Keywords
- sleep, actigraphy
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep EducationBehavioural
The subject will undergo a 30-minute session on sleep education from one of the study coordinators.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Education | Experimental | The intervention will be a brief education of the importance of sleep and healthy sleep habits. Subjects will also receive a standard sleep brochure on healthy sleep (which will also be given to the other arm). Receives: Behavioral: Sleep Education |
| Sleep Brochure | No intervention | Subjects will receive a one page hand out on healthy sleep habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Duration
Change in sleep duration pre and post-college start
Measured: Baseline, 4 weeks, 8 weeks
Change in Weight
Change in weight pre and post-college start
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (3)
Symptoms of Depression
Symptoms of depression as assessed by standard questionnaire
Measured: Baseline, 4 weeks, 8 weeks
Symptoms of Anxiety
Symptoms of anxiety as assessed by standard questionnaire
Measured: Baseline, 4 weeks, 8 weeks
Reaction Time
Psychomotor vigilence testing
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start22 Jun 2017
- Primary completion18 Dec 2017
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventative HealthStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half the subjects will be followed without any attempt to improve sleep, and half will undergo a brief educational intervention to try to improve sleep.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Robert Owens, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214523
- Sponsor's protocol ID
- 17-0761
- Acronym
- FRoSH
- Status last verified
- Jan 2018
- First submitted
- 6 Jul 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at the current time to share data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freshman Sleep and Health Project
- ClinicalTrials.gov ID
- NCT03214523
- Acronym / sponsor ID
- FRoSH / 17-0761
- Conditions
- Preventative Health, Sleep, Weight
- Keywords
- sleep, actigraphy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 11 Jul 2017 (actual)
- 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.
Sleep is a clearly necessary neurobiologic process that influences innumerable aspects of basic daily functions, physical health, and mental well-being. Recent literature shows that college students across the country are experiencing high rates of sleep deprivation. Interestingly, some recent studies have implicated this sleep loss in contributing to weight gain that occurs in the first year of college, also known as the "freshman fifteen." Rates of depression and other mental health issues, which are closely connected to sleep disturbances, are also on the rise in college campuses. The majority of the sleep data obtained in this population has been via questionnaires and self report, and the studies usually include college students at all seniority levels (e.g., freshmen, sophomores, seniors). Here, the investigators outline a novel study investigating how sleep time changes in college freshman, and how it relates to multiple different aspects of their health and functioning over the course of one quarter.
As technology has advanced, the ability to easily obtain objective measurements of different health parameters has increased dramatically. The investigators plan to use wireless actigraphy devices to measure sleep over a baseline seven day period in college-bound UCSD students prior to matriculation, and for 2 additional seven day periods during the first quarter of college. To the knowledge of the investigators, this is the first study to directly measure sleep time in college freshman in their normal environment. Effects of sleep time loss will be evaluated through multiple different metrics of physical and mental health. Given the recent link between sleep disturbances and weight gain in college freshman, the investigators will plan to measure weight changes prior to entering college and at two different time points through the first quarter. The investigators will use the PSQ-9 and GAD7 batteries as measures of mental health, obtained at the same time points as the sleep and weight information. As one of the primary consequences of sleep deprivation is on neurocognition in the daytime, the investigators plan to measure vigilant attention using psychomotor vigilance testing (PVT) as well. Screen time use has recently been targeted as a possible contributor to sleep loss in adolescents as well as adults and is something the investigators will attempt to measure as well using a smartphone application. Finally, this project will test the efficacy of a one hour sleep education intervention on improving total sleep time.
To the knowledge of the investigators, no other studies have closely examined how total sleep time changes during the first year of college in freshman in relationship to weight and mental health parameters, nor has PVT been done in this context. Additionally, with the increasing concerns regarding screen time use in adolescents and young adults, this study provides prime opportunity to examine this issue in the context of sleep.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Half the subjects will be followed without any attempt to improve sleep, and half will undergo a brief educational intervention to try to improve sleep.
| Arm | Type | Receives |
|---|---|---|
| Sleep Education | Experimental | Behavioral: Sleep EducationThe intervention will be a brief education of the importance of sleep and healthy sleep habits. Subjects will also receive a standard sleep brochure on healthy sleep (which will also be given to the other arm). |
| Sleep Brochure | No intervention | –Subjects will receive a one page hand out on healthy sleep habits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Incoming UCSD freshman
Key exclusion criteria (2 listed)
- Under 18 years of age
- Not living on UCSD campus
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 |
|---|---|---|
| Sleep EducationThe subject will undergo a 30-minute session on sleep education from one of the study coordinators. | Behavioural | Sleep Education |
Primary outcome
Change in Sleep Duration
Time frame: Baseline, 4 weeks, 8 weeks
Change in sleep duration pre and post-college start
Change in Weight
Time frame: Baseline, 4 weeks, 8 weeks
Change in weight pre and post-college start
3 secondary outcomes
Symptoms of Depression
Time frame: Baseline, 4 weeks, 8 weeks
Symptoms of Anxiety
Time frame: Baseline, 4 weeks, 8 weeks
Reaction Time
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Individual participant dataSharing planned: No. There is no plan at the current time to share data with other researchers.
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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.
Robert Owens, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Education in people with Preventative Health and Sleep, run by University of California, San Diego 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 1 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: status not confirmed, as of the sponsor's last update on 5 Jan 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?
Results are not available in the source record.
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?
Change in Sleep Duration (time frame: Baseline, 4 weeks, 8 weeks). 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?
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 5 Jan 2018.