NCT05011318

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

August 25, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

August 12, 2021

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • 2-Back Task (Change)

    Change in Accuracy over time

    during fatigue manipulation

  • 2-Back Task (Change)

    Change in Reaction Time over time

    during fatigue manipulation

  • Fatigue State Questionnaire

    Fatigue State Questionnaire Score

    up to 5 mins after fatigue manipulation

  • Electrocardiograph (Change)

    Change in Heart Rate Variability over time

    during fatigue manipulation

  • Electrodermal Activity (Change)

    Change in Skin Conductance Level over time

    during fatigue manipulation

  • Electrodermal Activity (Change)

    Change in Skin Conductance Response over time

    during fatigue manipulation

Study Arms (1)

Fatigue Manipulation

EXPERIMENTAL
Other: BaselineOther: Fatigue Manipulation

Interventions

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

Fatigue Manipulation

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

Fatigue Manipulation

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Singapore-based
  • Non-clinical
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cultural Science Innovations, Nanyang Technological University

Singapore, 639798, Singapore

RECRUITING

Related 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.

    PMID: 34199416BACKGROUND

MeSH Terms

Conditions

Mental Fatigue

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Central Study Contacts

Kar Fye Alvin Lee, PhD

CONTACT

GEORGIOS CHRISTOPOULOS, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 18, 2021

Study Start

August 25, 2021

Primary Completion

May 15, 2023

Study Completion

June 15, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations