Freshman Sleep and Health Project

NCT ID: NCT03214523

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preventative Health Sleep Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants were recruited without emphasis on study arm. All outcomes will be assessed without knowledge of the treatment arm.

Study Groups

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Sleep Education

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).

Group Type EXPERIMENTAL

Sleep Education

Intervention Type BEHAVIORAL

The subject will undergo a 30-minute session on sleep education from one of the study coordinators.

Sleep Brochure

Subjects will receive a one page hand out on healthy sleep habits.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sleep Education

The subject will undergo a 30-minute session on sleep education from one of the study coordinators.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Incoming UCSD freshman

Exclusion Criteria

* Under 18 years of age
* Not living on UCSD campus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Robert L. Owens

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Owens, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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University of California San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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17-0761

Identifier Type: -

Identifier Source: org_study_id

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