Cognitive FatigueFRAPSNCT05012293
Cognitive Fatigue, Self-Regulation, and Academic Performance: A Physiological Study
A study testing Baseline and Fatigue Manipulation in people with Cognitive Fatigue and Mental Fatigue, run by Nanyang Technological University at 1 site in Singapore.
Trial summary
This study aims to examine the relationship among cognitive fatigue, self-regulation, and academic performance. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Fatigue, Mental Fatigue, Behavioral Performance
- What is being tested?
- Baseline and Fatigue Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Aug 2021to 15 Jun 2023
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singapore-based
- Non-clinical
- 18-35years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Cultural Science Innovations, Nanyang Technological University
Singapore, 639798
Elliot Chan, B.A., +6596799914, elliotchan@ntu.edu.sg
About this study
This study aims to examine the relationship among cognitive fatigue, self-regulation, and academic performance.
Read the detailed description
- 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.
- Conditions
- Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Skin Conductance, Academic Performance
- Being tested
- Baseline, Fatigue Manipulation
- Medical subject headings
- Mental Fatigue, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaselineOther
5-min urban park video clip (Presented on a TV)
Fatigue ManipulationOther
20-min 2-back task (Presented on a computer)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Fatigue Manipulation | Experimental | Not described Receives: Other: Baseline; Other: Fatigue Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Back Task (Change)
Change in Accuracy over time
Measured: during fatigue manipulation procedure
2-Back Task (Change)
Change in Reaction Time over time
Measured: during fatigue manipulation procedure
Fatigue State Questionnaire
Fatigue State Questionnaire Score
Measured: up to 5 mins after fatigue manipulation
Electrocardiograph (Change)
Change in Heart Rate Variability over time
Measured: during fatigue manipulation procedure
Electrodermal Activity (Change)
Change in Skin Conductance Level over time
Measured: during fatigue manipulation procedure
Electrodermal Activity (Change)
Change in Skin Conductance Response over time
Measured: during fatigue manipulation procedure
Short Self-Regulation Questionnaire
Short Self-Regulation Questionnaire Score
Measured: up to 1 hour before fatigue manipulation
Academic Performance
Self-reported Academic Results
Measured: up to 1 hour before fatigue manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start26 Aug 2021
- Primary completion15 May 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive FatigueStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore
- Responsible party
- Principal investigator, Georgios CHRISTOPOULOS, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012293
- Sponsor's protocol ID
- COT-V4-2020-1-S003
- Acronym
- FRAPS
- Status last verified
- Mar 2023
- First submitted
- 12 Aug 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Oct 1;41(5):289-297. doi: 10.1123/jsep.2018-0222.
PubMed 31509795Sievertsen 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.
PubMed 26884183
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Fatigue, Self-Regulation, and Academic Performance: A Physiological Study
- ClinicalTrials.gov ID
- NCT05012293
- Acronym / sponsor ID
- FRAPS / COT-V4-2020-1-S003
- Conditions
- Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Skin Conductance, Academic Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 19 Aug 2021 (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.
This study aims to examine the relationship among cognitive fatigue, self-regulation, and academic performance.
Detailed description
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Fatigue Manipulation | Experimental | Other: Baseline, Other: Fatigue Manipulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singapore-based
- Non-clinical
- 18-35years
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Baseline5-min urban park video clip (Presented on a TV) | Other | Experimental: Fatigue Manipulation |
| Fatigue Manipulation20-min 2-back task (Presented on a computer) | Other | Experimental: Fatigue Manipulation |
Primary outcome
2-Back Task (Change)
Time frame: during fatigue manipulation procedure
Change in Accuracy over time
2-Back Task (Change)
Time frame: during fatigue manipulation procedure
Change in Reaction Time over time
Fatigue State Questionnaire
Time frame: up to 5 mins after fatigue manipulation
Fatigue State Questionnaire Score
Electrocardiograph (Change)
Time frame: during fatigue manipulation procedure
Change in Heart Rate Variability over time
Electrodermal Activity (Change)
Time frame: during fatigue manipulation procedure
Change in Skin Conductance Level over time
Electrodermal Activity (Change)
Time frame: during fatigue manipulation procedure
Change in Skin Conductance Response over time
Short Self-Regulation Questionnaire
Time frame: up to 1 hour before fatigue manipulation
Short Self-Regulation Questionnaire Score
Academic Performance
Time frame: up to 1 hour before fatigue manipulation
Self-reported Academic Results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 31509795Martin 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 Oct 1;41(5):289-297. doi: 10.1123/jsep.2018-0222.
- Background: PubMed 26884183Sievertsen 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline and Fatigue Manipulation in people with Cognitive Fatigue and Mental Fatigue, run by Nanyang Technological University at 1 site in Singapore.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kar Fye Alvin Lee, PhD (+6591557981, alvin.lee@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Back Task (Change) (time frame: during fatigue manipulation procedure). The study lists 8 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 NCT05012293, which also lists 2 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 23 Mar 2023.