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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Participants will be deceived during delayed gratification task.
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
Participants will be deceived during delayed gratification task.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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
Morningness-eveningness Questionnaire
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
Sleep quantity
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

Low Self-Control Scale (LSC)

  • Low self-control scale (24 items) measures low self-control.
  • The total score ranges from 1 to 5.
  • Five subscales called impulsivity, simple tasks, risk seeking, physical activities, self-centered, and temper, each provide subscale score ranging from 1 to 5.
  • Higher values indicate higher lower self-control, in other words, worse outcomes.
  • A total score is developed by averaging all 24 items across all subscales. Subscale scores also represent the averaged responses to their corresponding items.
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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

Zuckerman Impulsivity and Sensation Seeking Scale

  • Impulsivity and Sensation Seeking Scale (19 items) measures impulsivity and sensation seeking.
  • Total score ranges from 0 to 19. Impulsivity (i.e., one of the two subscales) score ranges from 0 to 8 (8 items), whereas Sensation Seeking score ranges from 0 to 11 (11 items).
  • For total as well as for each subscale scores, higher values indicate more impulsivity and sensation seeking, respectively.
  • Total and subscale scores are computed by summing the responses (19, 11, and 8 items respectively).
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
Weinberger Adjustment Inventory
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

  • Normative Deviance Scale-Short Form (21 items); the scale measures involvement in deviant and norm-violating behaviors.
  • Total scores range from 1 to 5. Seven subscale scores (i.e., vandalism, alcohol use, drug use, school misconduct, general deviance, theft, assault) each range from 1 to 5, 3 items each.
  • Higher scores indicate greater deviance (more frequent involvement), in other word, worse outcome.
  • A total score, as well as subscale scores, are computed by averaging responses of the corresponding items.
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
Grade point average (GPA)/Scholastic Aptitude Test (SAT)/American College Test (ACT) Score
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Academic Dishonesty Scale
Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Rested versus sleep deprived group differences in school attitudes
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
Academic Concentration Measure
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
Academic Expectations and Aspirations
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
School Attitudes Assessment Survey
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
NIH toolbox Cognition Battery
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
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
NIH toolbox Cognition Battery
Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
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
Balloon Analogue Risk Task (BART)
Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexander Vazsonyi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings