Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance (FRESH)
Primary Purpose
Cognitive Fatigue, Mental Fatigue, Behavioral Performance
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Baseline
Fatigue Manipulation
Sponsored by
About this trial
This is an interventional diagnostic trial for Cognitive Fatigue
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
Sites / Locations
- Cultural Science Innovations, Nanyang Technological UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05011318
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
NCT05011318
Brief Title
Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance
Acronym
FRESH
Official Title
Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to examine the effects of cognitive fatigue on heart rate variability and skin conductance and develop a machine learning model.
Detailed Description
We hypothesize that increased cognitive fatigue would vary as a function of heart rate variability and skin conductance. A machine learning model will be developed that predicts cognitive fatigue through these physiological responses (Lee et al., 2021). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, sleep quality, 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
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
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
Title
2-Back Task (Change)
Description
Change in Reaction Time over time
Time Frame
during fatigue manipulation
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
Title
Electrodermal Activity (Change)
Description
Change in Skin Conductance Level over time
Time Frame
during fatigue manipulation
Title
Electrodermal Activity (Change)
Description
Change in Skin Conductance Response over time
Time Frame
during 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
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
Email
alvin.lee@ntu.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
GEORGIOS CHRISTOPOULOS, PhD
Phone
+6594898379
Email
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
Email
elliotchan@ntu.edu.sg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34199416
Citation
Lee KFA, Gan WS, Christopoulos G. Biomarker-Informed Machine Learning Model of Cognitive Fatigue from a Heart Rate Response Perspective. Sensors (Basel). 2021 Jun 2;21(11):3843. doi: 10.3390/s21113843.
Results Reference
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Learn more about this trial
Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance
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