Freshman Sleep and Health Project

NCT03214523 | Unknown

• 1 other identifier: 17-0761
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preventative Health; Sleep; Weight

Keywords

sleep; actigraphy

Outcome Measures

Primary Outcomes (2)

• Change in Sleep Duration

  Change in sleep duration pre and post-college start

  Baseline, 4 weeks, 8 weeks

• Change in Weight

  Change in weight pre and post-college start

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (3)

• Symptoms of Depression

  Baseline, 4 weeks, 8 weeks

• Symptoms of Anxiety

  Baseline, 4 weeks, 8 weeks

• Reaction Time

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

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).

Behavioral: Sleep Education

Sleep Brochure

NO INTERVENTION

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

Interventions

Sleep Education BEHAVIORAL

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

Sleep Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Incoming UCSD freshman

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Owens, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were recruited without emphasis on study arm. All outcomes will be assessed without knowledge of the treatment arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: June 22, 2017
• Primary Completion: December 18, 2017
• Study Completion: December 31, 2018
• Last Updated: January 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)