Clinical trial NCT03214523: Freshman Sleep and Health Project
Official title: Freshman Sleep and Health Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preventative Health
Sleep
Weight
Keywords: sleep
actigraphy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Incoming UCSD freshman

Exclusion Criteria:

* Under 18 years of age
* Not living on UCSD campus

Primary outcomes:
measure: Change in Sleep Duration
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in Weight
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Symptoms of Depression
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Symptoms of Anxiety
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Reaction Time
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Robert Owens, MD
role: PRINCIPAL_INVESTIGATOR
References: