- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05012293
Cognitive Fatigue, Self-Regulation, and Academic Performance: A Physiological Study (FRAPS)
March 21, 2023 updated by: Georgios CHRISTOPOULOS, Nanyang Technological University
This study aims to examine the relationship among cognitive fatigue, self-regulation, and academic performance.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
1) Sievertsen et al. (2016) have demonstrated that standardised test performance decreased with every hour later in the day and increased after a break.
Hence, we hypothesise that standardised test performance would vary as a function of physiological response during cognitive fatigue.
2) Martin et al. (2019) found that those who participate in more self-regulatory activity were less susceptible to the effects of cognitive fatigue.
Hence, we hypothesise that greater self-regulation may moderate the relationship between cognitive fatigue and standardised test performance.
Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, sleep quality, depression, anxiety, stress, baseline physiology and behavioural performance) will be examined and accounted for.
Study Type
Interventional
Enrollment (Anticipated)
162
Phase
- Not Applicable
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
-
-
-
Singapore, Singapore, 639798
- Recruiting
- Cultural Science Innovations, Nanyang Technological University
-
-
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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Singapore-based
- Non-clinical
- 18-35years
Exclusion Criteria:
- Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing
- Individuals with a history of ear, developmental, neurological, or psychiatric disorder
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Fatigue Manipulation
|
5-min urban park video clip (Presented on a TV)
20-min 2-back task (Presented on a computer)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-Back Task (Change)
Time Frame: during fatigue manipulation procedure
|
Change in Accuracy over time
|
during fatigue manipulation procedure
|
2-Back Task (Change)
Time Frame: during fatigue manipulation procedure
|
Change in Reaction Time over time
|
during fatigue manipulation procedure
|
Fatigue State Questionnaire
Time Frame: up to 5 mins after fatigue manipulation
|
Fatigue State Questionnaire Score
|
up to 5 mins after fatigue manipulation
|
Electrocardiograph (Change)
Time Frame: during fatigue manipulation procedure
|
Change in Heart Rate Variability over time
|
during fatigue manipulation procedure
|
Electrodermal Activity (Change)
Time Frame: during fatigue manipulation procedure
|
Change in Skin Conductance Level over time
|
during fatigue manipulation procedure
|
Electrodermal Activity (Change)
Time Frame: during fatigue manipulation procedure
|
Change in Skin Conductance Response over time
|
during fatigue manipulation procedure
|
Short Self-Regulation Questionnaire
Time Frame: up to 1 hour before fatigue manipulation
|
Short Self-Regulation Questionnaire Score
|
up to 1 hour before fatigue manipulation
|
Academic Performance
Time Frame: up to 1 hour before fatigue manipulation
|
Self-reported Academic Results
|
up to 1 hour before fatigue manipulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Sievertsen HH, Gino F, Piovesan M. Cognitive fatigue influences students' performance on standardized tests. Proc Natl Acad Sci U S A. 2016 Mar 8;113(10):2621-4. doi: 10.1073/pnas.1516947113. Epub 2016 Feb 16.
- Martin K, Thompson KG, Keegan R, Rattray B. Are Individuals Who Engage in More Frequent Self-Regulation Less Susceptible to Mental Fatigue? J Sport Exerc Psychol. 2019 Sep 11:1-9. doi: 10.1123/jsep.2018-0222. Online ahead of print.
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)
August 26, 2021
Primary Completion (Anticipated)
May 15, 2023
Study Completion (Anticipated)
June 15, 2023
Study Registration Dates
First Submitted
August 12, 2021
First Submitted That Met QC Criteria
August 18, 2021
First Posted (Actual)
August 19, 2021
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COT-V4-2020-1-S003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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