NCT03549377

Brief Summary

The main objectives of the study include: 1. What are the differences in self-regulation and its neurophysiological and neuroanatomical correlates between college students with poor and excellent sleep functioning? 2. Does sleep functioning (assessed both by questionnaires and actigraphy), and self-control/self-regulation (questionnaire and imaging data) predict academic achievement and problem behaviors in college students?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

May 14, 2018

Last Update Submit

September 16, 2019

Conditions

Keywords

SleepAcademic functioningProblem behaviorsCollege age youthSelf-regulation

Outcome Measures

Primary Outcomes (4)

  • Rested versus sleep deprived group differences of Functional magnetic resonance imaging (fMRI) Blood oxygenation level dependent (BOLD) responses for Stop Signal Reaction Time Task (SSRT) Stop Signals

    Rested versus sleep deprived group differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Stop Signal Reaction Time Task

    Up to 45 days following selection for inclusion based on prescreen, cross-sectional study

  • Rested versus sleep deprived group differences of fMRI BOLD responses for a Go-NoGo Continuous Performance Task (CPT)

    Rested versus sleep deprived group differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Go-NoGo Continuous Performance Task

    Up to 45 days following selection for inclusion based on prescreen, cross-sectional study

  • Rested versus sleep deprived group differences of brain structural connectivity

    Rested versus sleep deprived group differences of brain structural connectivity as measured by diffusion tensor imaging and analyzed using tract-based spatial statistics

    Up to 45 days following selection for inclusion based on prescreen, cross-sectional study

  • Rested versus sleep deprived group differences of brain structure

    Rested versus sleep deprived group differences of brain structure as determined by voxel based morphometry of structural magnetic resonance imaging data

    Up to 45 days following selection for inclusion based on prescreen, cross-sectional study

Other Outcomes (15)

  • Rested versus sleep deprived group differences in sleep time preferences

    Up to 45 days following selection for inclusion based on prescreen, cross-sectional study

  • Rested versus sleep deprived group differences in hours of sleep

    Up to 45 days following selection for inclusion based on prescreen, cross-sectional studyUp to 45 days following selection for inclusion based on prescreen, cross-sectional study

  • Rested versus sleep deprived group differences in low self-control

    Up to 45 days following selection for inclusion based on prescreen, cross-sectional study

  • +12 more other outcomes

Study Arms (2)

Rested

Based on Pittsburgh Sleep Quality Index, participants scoring in the top 10-20% will be assigned to the rested group and will experience deception as part of the delayed gratification task

Behavioral: Deception

Sleep-deprived

Based on Pittsburgh Sleep Quality Index, participants scoring in the bottom 10-20% will be assigned to the sleep-deprived group and will experience deception as part of the delayed gratification task

Behavioral: Deception

Interventions

DeceptionBEHAVIORAL

Participants will be deceived during delayed gratification task.

RestedSleep-deprived

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study sample will consist of 24 healthy college students (12 males and 12 females) between ages 18 - 24 years.

You may qualify if:

  • Healthy college-age youth between the ages of 18 and 24 years

You may not qualify if:

  • Gross impairment of vision or hearing
  • Inability to read and follow written instructions
  • Physical, neurological, or concurrent psychiatric impairments
  • Regular intake of psychotropic medication (such as methylphenidate used to treat Attention Deficit Hyperactivity Disorder (ADHD), antidepressants, or anti-anxiety medication)
  • A history of head injury that resulted in loss of consciousness/a history of brain surgery/or seizures
  • A current/past history of smoking and/or alcohol or drug abuse (i.e., five or more drinks in one sitting or 15 drinks or more during a week for men, and four drinks on one occasion or eight drinks over the course of a week for women; additionally, regular drug use, including marijuana)
  • Current pregnancy
  • Any metallic objects in your body (such as braces, pacemakers, surgical devices, piercings that cannot be removed etc.) Enrollment of the subjects will start in May 2018 and will be finished by the end of December 2018.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (4)

  • Gottfredson MR, Hirschi T. A general theory of crime. Stanford: Stanford University Press; 1990.

    BACKGROUND
  • Steinberg L, Albert D, Cauffman E, Banich M, Graham S, Woolard J. Age differences in sensation seeking and impulsivity as indexed by behavior and self-report: evidence for a dual systems model. Dev Psychol. 2008 Nov;44(6):1764-78. doi: 10.1037/a0012955.

    PMID: 18999337BACKGROUND
  • Owens JA, Dearth-Wesley T, Lewin D, Gioia G, Whitaker RC. Self-Regulation and Sleep Duration, Sleepiness, and Chronotype in Adolescents. Pediatrics. 2016 Dec;138(6):e20161406. doi: 10.1542/peds.2016-1406. Epub 2016 Nov 3.

    PMID: 27940688BACKGROUND
  • Wheaton AG, Jones SE, Cooper AC, Croft JB. Short Sleep Duration Among Middle School and High School Students - United States, 2015. MMWR Morb Mortal Wkly Rep. 2018 Jan 26;67(3):85-90. doi: 10.15585/mmwr.mm6703a1.

    PMID: 29370154BACKGROUND

MeSH Terms

Conditions

Self-ControlProblem Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavioral SymptomsChild Behavior

Study Officials

  • Alexander T Vazsonyi, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Endowed Professor

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 8, 2018

Study Start

May 11, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

No plan at this time

Locations