FRESH: Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance

Sponsor
Nanyang Technological University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05011318
Collaborator
National Research Foundation, Singapore (Other), Ministry of National Development, Singapore (Other), Housing and Development Board, Singapore (Other)
162
Enrollment
1
Location
1
Arm
3.7
Anticipated Duration (Months)
44
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Baseline
  • Other: Fatigue Manipulation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance
Actual Study Start Date :
Aug 25, 2021
Anticipated Primary Completion Date :
Oct 15, 2021
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Fatigue Manipulation

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

Other: Fatigue Manipulation
20-min 2-back task (Presented on a computer)

Outcome Measures

Primary Outcome Measures

  1. 2-Back Task (Change) [during fatigue manipulation]

    Change in Accuracy over time

  2. 2-Back Task (Change) [during fatigue manipulation]

    Change in Reaction Time over time

  3. Fatigue State Questionnaire [up to 5 mins after fatigue manipulation]

    Fatigue State Questionnaire Score

  4. Electrocardiograph (Change) [during fatigue manipulation]

    Change in Heart Rate Variability over time

  5. Electrodermal Activity (Change) [during fatigue manipulation]

    Change in Skin Conductance Level over time

  6. Electrodermal Activity (Change) [during fatigue manipulation]

    Change in Skin Conductance Response over time

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Singapore-based

  • Non-clinical

  • 21-30years

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cultural Science Innovations, Nanyang Technological UniversitySingaporeSingapore639798

Sponsors and Collaborators

  • Nanyang Technological University
  • National Research Foundation, Singapore
  • Ministry of National Development, Singapore
  • Housing and Development Board, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Georgios CHRISTOPOULOS, Associate Professor, Nanyang Technological University
ClinicalTrials.gov Identifier:
NCT05011318
Other Study ID Numbers:
  • COT-V4-2020-1-S002
First Posted:
Aug 18, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021