Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT05011318
Status:
UNKNOWN
Last Update Posted:
2023-03-23
First Post:
2021-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}], 'ancestors': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C074807', 'term': 'BaseLine dental cement'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2021-08-12', 'studyFirstSubmitQcDate': '2021-08-12', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-Back Task (Change)', 'timeFrame': 'during fatigue manipulation', 'description': 'Change in Accuracy over time'}, {'measure': '2-Back Task (Change)', 'timeFrame': 'during fatigue manipulation', 'description': 'Change in Reaction Time over time'}, {'measure': 'Fatigue State Questionnaire', 'timeFrame': 'up to 5 mins after fatigue manipulation', 'description': 'Fatigue State Questionnaire Score'}, {'measure': 'Electrocardiograph (Change)', 'timeFrame': 'during fatigue manipulation', 'description': 'Change in Heart Rate Variability over time'}, {'measure': 'Electrodermal Activity (Change)', 'timeFrame': 'during fatigue manipulation', 'description': 'Change in Skin Conductance Level over time'}, {'measure': 'Electrodermal Activity (Change)', 'timeFrame': 'during fatigue manipulation', 'description': 'Change in Skin Conductance Response over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Fatigue', 'Mental Fatigue', 'Behavioral Performance', 'Heart Rate Variability', 'Skin Conductance']}, 'referencesModule': {'references': [{'pmid': '34199416', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effects of cognitive fatigue on heart rate variability and skin conductance and develop a machine learning model.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singapore-based\n* Non-clinical\n* 18-35years\n\nExclusion Criteria:\n\n* Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing\n* Individuals with a history of ear, developmental, neurological, or psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT05011318', 'acronym': 'FRESH', 'briefTitle': 'Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance', 'organization': {'class': 'OTHER', 'fullName': 'Nanyang Technological University'}, 'officialTitle': 'Effects of Cognitive Fatigue on Heart Rate Variability and Skin Conductance', 'orgStudyIdInfo': {'id': 'COT-V4-2020-1-S002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fatigue Manipulation', 'interventionNames': ['Other: Baseline', 'Other: Fatigue Manipulation']}], 'interventions': [{'name': 'Baseline', 'type': 'OTHER', 'description': '5-min urban park video clip (Presented on a TV)', 'armGroupLabels': ['Fatigue Manipulation']}, {'name': 'Fatigue Manipulation', 'type': 'OTHER', 'description': '20-min 2-back task (Presented on a computer)', 'armGroupLabels': ['Fatigue Manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '639798', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Elliot Chan, B.A.', 'role': 'CONTACT', 'email': 'elliotchan@ntu.edu.sg', 'phone': '+6596799914'}], 'facility': 'Cultural Science Innovations, Nanyang Technological University', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Kar Fye Alvin Lee, PhD', 'role': 'CONTACT', 'email': 'alvin.lee@ntu.edu.sg', 'phone': '+6591557981'}, {'name': 'GEORGIOS CHRISTOPOULOS, PhD', 'role': 'CONTACT', 'email': 'georchris7@gmail.com', 'phone': '+6594898379'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanyang Technological University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation, Singapore', 'class': 'OTHER_GOV'}, {'name': 'Ministry of National Development, Singapore', 'class': 'OTHER_GOV'}, {'name': 'Housing and Development Board, Singapore', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Georgios CHRISTOPOULOS', 'investigatorAffiliation': 'Nanyang Technological University'}}}}