- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03549377
Neural Correlates of Self-regulation on Academic Functioning
September 16, 2019 updated by: Alexander Vazsonyi
Neural Correlates of the Associations Between Sleep Functioning, Self-regulation, Academic Functioning, and Problem Behaviors
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?
Study Overview
Detailed Description
Based on the Self-Control Theory, individual differences in characteristics such as impulsivity, risk-seeking, and self-regulation consistently predict health-compromising and problem behaviors as well as academic functioning and success in adolescents and young adults.[1]
Although suboptimal self-regulation is normative in adolescence and young adulthood, [2] it might result in negative consequences for adolescents' and young adults' health and well-being, including substance use, school/college dropout, or troubles with law.
A recent line of research suggested that self-regulation problems are associated with insufficient and poor sleep.[3]
As adolescents and young adults frequently report poor sleep functioning,[4] their self-regulation abilities might be further compromised by unfavorable sleep functioning with consequences for youths' problem behaviors and academic success.
To mitigate this problem, some efforts have followed to ensure that adolescents get enough quality sleep (e.g., delayed school start times).
However, the associations between sleep functioning, self-regulation, academic functioning, and problem behaviors were established predominantly using questionnaire data.
Neurophysiological correlates of these associations have not been extensively studied.
In the proposed study, this gap in scholarship will be addressed by linking sleep functioning to self-regulation indicated by neuropsychological and neuroanatomical data, and predicting academic achievement and problem behaviors with sleep and self-regulation.
This explorative, pilot study is a first step in efforts to understand the issue; it will be carried out with a college student sample (N = 48, 50% female) which will also have implications for future research focused on adolescents (middle and high school students).
Pilot data will inform the development of a larger study that will include adolescents (middle and high school students) and will support grant applications.
Results will have a potential for prevention /intervention programs and policy targeting youth, such as school start times setting.
This study will be carried out as a collaboration between the Department of Family Sciences at the University of Kentucky and the Department of Human Development and Family Studies at the Texas Tech University.
Data will be collected following the same procedures described in this application both at the University of Kentucky and Texas Tech campuses.
Research team at the Texas Tech University has submitted their own Institutional Review Board (IRB) application that is now being reviewed.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40506
- University Of Kentucky
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study sample will consist of 24 healthy college students (12 males and 12 females) between ages 18 - 24 years.
Description
Inclusion Criteria:
Healthy college-age youth between the ages of 18 and 24 years
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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Participants will be deceived during delayed gratification task.
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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
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Participants will be deceived during delayed gratification task.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Stop Signal Reaction Time Task
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences of fMRI BOLD responses for a Go-NoGo Continuous Performance Task (CPT)
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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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
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Rested versus sleep deprived group differences of brain structural connectivity
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences of brain structural connectivity as measured by diffusion tensor imaging and analyzed using tract-based spatial statistics
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences of brain structure
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences of brain structure as determined by voxel based morphometry of structural magnetic resonance imaging data
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rested versus sleep deprived group differences in sleep time preferences
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Morningness-eveningness Questionnaire
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences in hours of sleep
Time Frame: 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
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Sleep quantity
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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
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Low Self-Control Scale (LSC)
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
|
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Rested versus sleep deprived group differences in sensation seeking and impulsivity
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Zuckerman Impulsivity and Sensation Seeking Scale
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
|
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Rested versus sleep deprived group differences in internalizing behaviors
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Weinberger Adjustment Inventory
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
|
|
Rested versus sleep deprived group differences in deviance/externalizing subscales
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
|
Normative Deviance Scale, Short Form
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
|
|
Rested versus sleep deprived group differences in GPA/SAT/ACT Scores
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Grade point average (GPA)/Scholastic Aptitude Test (SAT)/American College Test (ACT) Score
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Academic Dishonesty Scale
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences in school attitudes
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences in academic concentration
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Academic Concentration Measure
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences in academic aspirations and expectations
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Academic Expectations and Aspirations
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences in school attitudes
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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School Attitudes Assessment Survey
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, List Sorting Working Memory Test
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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NIH toolbox Cognition Battery
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Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test,
Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
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NIH toolbox Cognition Battery
|
Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
|
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Rested versus sleep deprived group differences in commission errors in Balloon Analogue Risk Task (BART), , omission errors
Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
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Balloon Analogue Risk Task (BART)
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Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
|
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Rested versus sleep deprived group differences in commission errors in a Go-NoGo CPT, omission errors
Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
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Go/NoGo continuous performance task (CPT)
|
Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander T Vazsonyi, Ph.D., University Of Kentucky
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gottfredson MR, Hirschi T. A general theory of crime. Stanford: Stanford University Press; 1990.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2018
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
August 31, 2019
Study Registration Dates
First Submitted
May 14, 2018
First Submitted That Met QC Criteria
May 24, 2018
First Posted (Actual)
June 8, 2018
Study Record Updates
Last Update Posted (Actual)
September 17, 2019
Last Update Submitted That Met QC Criteria
September 16, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 44065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No plan at this time
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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