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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03549377
Other study ID # 44065
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 11, 2018
Est. completion date August 31, 2019

Study information

Verified date September 2019
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Deception
Participants will be deceived during delayed gratification task.

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Alexander Vazsonyi

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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). pii: e20161406. Epub 2016 Nov 3. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Rested versus sleep deprived group differences in sleep time preferences Morningness-eveningness Questionnaire Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in hours of sleep 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
Other Rested versus sleep deprived group differences in low self-control 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
Other Rested versus sleep deprived group differences in sensation seeking and impulsivity 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
Other Rested versus sleep deprived group differences in internalizing behaviors Weinberger Adjustment Inventory Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in deviance/externalizing subscales 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
Other Rested versus sleep deprived group differences in GPA/SAT/ACT Scores 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
Other Academic Dishonesty Scale Rested versus sleep deprived group differences in school attitudes Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in academic concentration Academic Concentration Measure Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in academic aspirations and expectations Academic Expectations and Aspirations Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in school attitudes School Attitudes Assessment Survey Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, List Sorting Working Memory Test NIH toolbox Cognition Battery Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test, NIH toolbox Cognition Battery Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in commission errors in Balloon Analogue Risk Task (BART), , omission errors Balloon Analogue Risk Task (BART) Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
Other Rested versus sleep deprived group differences in commission errors in a Go-NoGo CPT, omission errors Go/NoGo continuous performance task (CPT) Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
Primary 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
Primary 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
Primary 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
Primary 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
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