Back to results

Cognitive Fatigue, Self-Regulation, and Academic Performance: A Physiological Study (FRAPS)

Primary Purpose

Cognitive Fatigue, Mental Fatigue, Behavioral Performance

Status

Recruiting

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Baseline

Fatigue Manipulation

About this trial

This is an interventional diagnostic trial for Cognitive Fatigue

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cultural Science Innovations, Nanyang Technological UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Fatigue Manipulation

Arm Description

Outcomes

Primary Outcome Measures

2-Back Task (Change)

Change in Accuracy over time

2-Back Task (Change)

Change in Reaction Time over time

Fatigue State Questionnaire

Fatigue State Questionnaire Score

Electrocardiograph (Change)

Change in Heart Rate Variability over time

Electrodermal Activity (Change)

Change in Skin Conductance Level over time

Electrodermal Activity (Change)

Change in Skin Conductance Response over time

Short Self-Regulation Questionnaire

Short Self-Regulation Questionnaire Score

Academic Performance

Self-reported Academic Results

Secondary Outcome Measures

Full Information

NCT ID

NCT05012293

First Posted

August 12, 2021

Last Updated

March 21, 2023

Sponsor

Nanyang Technological University

Collaborators

National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT05012293

Brief Title

Cognitive Fatigue, Self-Regulation, and Academic Performance: A Physiological Study

Acronym

FRAPS

Official Title

Cognitive Fatigue, Self-Regulation, and Academic Performance: A Physiological Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 26, 2021 (Actual)

Primary Completion Date

May 15, 2023 (Anticipated)

Study Completion Date

June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanyang Technological University

Collaborators

National Research Foundation, Singapore, Ministry of National Development, Singapore, Housing and Development Board, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to examine the relationship among cognitive fatigue, self-regulation, and academic performance.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Fatigue, Mental Fatigue, Behavioral Performance, Heart Rate Variability, Skin Conductance, Academic Performance, Self-regulation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Fatigue Manipulation

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Baseline

Intervention Description

5-min urban park video clip (Presented on a TV)

Intervention Type

Other

Intervention Name(s)

Fatigue Manipulation

Intervention Description

20-min 2-back task (Presented on a computer)

Primary Outcome Measure Information:

Title

2-Back Task (Change)

Description

Change in Accuracy over time

Time Frame

during fatigue manipulation procedure

Title

2-Back Task (Change)

Description

Change in Reaction Time over time

Time Frame

during fatigue manipulation procedure

Title

Fatigue State Questionnaire

Description

Fatigue State Questionnaire Score

Time Frame

up to 5 mins after fatigue manipulation

Title

Electrocardiograph (Change)

Description

Change in Heart Rate Variability over time

Time Frame

during fatigue manipulation procedure

Title

Electrodermal Activity (Change)

Description

Change in Skin Conductance Level over time

Time Frame

during fatigue manipulation procedure

Title

Electrodermal Activity (Change)

Description

Change in Skin Conductance Response over time

Time Frame

during fatigue manipulation procedure

Title

Short Self-Regulation Questionnaire

Description

Short Self-Regulation Questionnaire Score

Time Frame

up to 1 hour before fatigue manipulation

Title

Academic Performance

Description

Self-reported Academic Results

Time Frame

up to 1 hour before fatigue manipulation

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kar Fye Alvin Lee, PhD

Phone

+6591557981

alvin.lee@ntu.edu.sg

First Name & Middle Initial & Last Name or Official Title & Degree

GEORGIOS CHRISTOPOULOS, PhD

Phone

+6594898379

georchris7@gmail.com

Facility Information:

Facility Name

Cultural Science Innovations, Nanyang Technological University

City

Singapore

ZIP/Postal Code

639798

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elliot Chan, B.A.

Phone

+6596799914

elliotchan@ntu.edu.sg

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31509795

Citation

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.

Results Reference

background

PubMed Identifier

26884183

Citation

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.

Results Reference

background

Learn more about this trial

Cognitive Fatigue, Self-Regulation, and Academic Performance: A Physiological Study

We'll reach out to this number within 24 hrs