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NCT05011318 Clinical Trial

Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance

Heart Rate Variability Clinical Trial

— FRESH  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05011318
Other study ID # COT-V4-2020-1-S002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 25, 2021
Est. completion date June 15, 2023

Study information
Verified date March 2023
Source Nanyang Technological University
Contact Kar Fye Alvin Lee, PhD
Phone +6591557981
Email alvin.lee@ntu.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to examine the effects of cognitive fatigue on heart rate variability and skin conductance and develop a machine learning model.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 162
Est. completion date June 15, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Baseline
5-min urban park video clip (Presented on a TV)
• Fatigue Manipulation
20-min 2-back task (Presented on a computer)

Locations
Country Name City State
Singapore Cultural Science Innovations, Nanyang Technological University Singapore

Sponsors (4)
Lead Sponsor Collaborator
Nanyang Technological University Housing and Development Board, Singapore, Ministry of National Development, Singapore, National Research Foundation, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 2-Back Task (Change) Change in Accuracy over time during fatigue manipulation
Primary 2-Back Task (Change) Change in Reaction Time over time during fatigue manipulation
Primary Fatigue State Questionnaire Fatigue State Questionnaire Score up to 5 mins after fatigue manipulation
Primary Electrocardiograph (Change) Change in Heart Rate Variability over time during fatigue manipulation
Primary Electrodermal Activity (Change) Change in Skin Conductance Level over time during fatigue manipulation
Primary Electrodermal Activity (Change) Change in Skin Conductance Response over time during fatigue manipulation
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