Self-ControlNCT03549377
Neural Correlates of Self-regulation on Academic Functioning
An observational study of Self-Control, run by Alexander Vazsonyi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-Control
- What is being tested?
- Deception
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2018to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study sample will consist of 24 healthy college students (12 males and 12 females) between ages 18 - 24 years.
Who may be able to join
- Healthy college-age youth between the ages of 18 and 24 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Self-Control
- Being tested
- Deception
- Keywords
- Sleep, Academic functioning, Problem behaviors, College age youth, Self-regulation
- Medical subject headings
- Self-Control, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeceptionBehavioural
Participants will be deceived during delayed gratification task.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Deception |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start11 May 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Self-ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Vazsonyi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Vazsonyi, University of Kentucky
- Investigators
- Alexander T Vazsonyi, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549377
- Sponsor's protocol ID
- 44065
- Status last verified
- Sep 2019
- First submitted
- 14 May 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this time
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.
PubMed 18999337Owens 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.
PubMed 27940688Wheaton 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.
PubMed 29370154
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of the Associations Between Sleep Functioning, Self-regulation, Academic Functioning, and Problem Behaviors
- ClinicalTrials.gov ID
- NCT03549377
- Acronym / sponsor ID
- 44065
- Conditions
- Self-Control
- Keywords
- Sleep, Academic functioning, Problem behaviors, College age youth, Self-regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexander VazsonyiUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rested | – | Behavioral: DeceptionBased 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 |
| Sleep-deprived | – | Behavioral: DeceptionBased 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 |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study sample will consist of 24 healthy college students (12 males and 12 females) between ages 18 - 24 years.
Key inclusion criteria (1 listed)
- Healthy college-age youth between the ages of 18 and 24 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeceptionParticipants will be deceived during delayed gratification task. | Behavioural | Rested, Sleep-deprived |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- BackgroundGottfredson MR, Hirschi T. A general theory of crime. Stanford: Stanford University Press; 1990.
- Background: PubMed 18999337Steinberg 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.
- Background: PubMed 27940688Owens 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.
- Background: PubMed 29370154Wheaton 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.
- Individual participant dataSharing planned: No. No plan at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander T Vazsonyi, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self-Control, run by Alexander Vazsonyi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549377, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.