FRoSH: Freshman Sleep and Health Project

Sponsor
University of California, San Diego (Other)
Overall Status
Unknown status
CT.gov ID
NCT03214523
Collaborator
(none)
100
1
2
18.3
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sleep Education
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant, Outcomes Assessor)
Masking Description:
Participants were recruited without emphasis on study arm. All outcomes will be assessed without knowledge of the treatment arm.
Primary Purpose:
Other
Official Title:
Freshman Sleep and Health Project
Actual Study Start Date :
Jun 22, 2017
Actual Primary Completion Date :
Dec 18, 2017
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

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

No Intervention: Sleep Brochure

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

Outcome Measures

Primary Outcome Measures

  1. Change in Sleep Duration [Baseline, 4 weeks, 8 weeks]

    Change in sleep duration pre and post-college start

  2. Change in Weight [Baseline, 4 weeks, 8 weeks]

    Change in weight pre and post-college start

Secondary Outcome Measures

  1. Symptoms of Depression [Baseline, 4 weeks, 8 weeks]

    Symptoms of depression as assessed by standard questionnaire

  2. Symptoms of Anxiety [Baseline, 4 weeks, 8 weeks]

    Symptoms of anxiety as assessed by standard questionnaire

  3. Reaction Time [Baseline, 4 weeks, 8 weeks]

    Psychomotor vigilence testing

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Incoming UCSD freshman
Exclusion Criteria:
  • Under 18 years of age

  • Not living on UCSD campus

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Diego San Diego California United States 92121

Sponsors and Collaborators

  • University of California, San Diego

Investigators

  • Principal Investigator: Robert Owens, MD, UCSD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert L. Owens, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT03214523
Other Study ID Numbers:
  • 17-0761
First Posted:
Jul 11, 2017
Last Update Posted:
Jan 5, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Robert L. Owens, Associate Professor, University of California, San Diego

Study Results

No Results Posted as of Jan 5, 2018