Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT05531734
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2022-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG data collected by head phone like EEG electrodes developed by NaoX Technologies', 'timeFrame': 'through study completion, an average of 12 hours', 'description': 'Demonstrate that the NaoX head phone like EEG electrodes detects sleep deprivation in medical residents performing medical shifts.\n\nThe primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements.\n\nThe data analysis will be blinded to the measurement.'}], 'secondaryOutcomes': [{'measure': 'Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by NaoX head phone like EEG electrodes and the vigilance tests', 'timeFrame': 'through study completion, an average of 12 hours', 'description': 'Endpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC).'}, {'measure': 'Demonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX head phone like EEG electrodes tool and the state of fatigue experienced', 'timeFrame': 'through study completion, an average of 12 hours', 'description': 'Endpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Measurement tool', 'EEG data', 'sleep deprivation', 'attention', 'electroencephalogram'], 'conditions': ['FATIGUE', 'Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.', 'detailedDescription': 'Objective and primary endpoint:\n\nDemonstrate that the NaoX measurement tool detects sleep deprivation in medical residents performing medical shifts.\n\nThe primary endpoint is the detection of a significant decrease in Coefficient Alpha Attenuation (CAA) between the pre- and post-sleep deprivation measurements.\n\nThe data analysis will be blinded to the measurement.\n\nSecondary endpoints and objectives :\n\nDemonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the vigilance tests.\n\nEndpoint: significant increase in PVT (Psychomotor Vigilance Task) time associated with a significant decrease in Alpha Attenuation Coefficient (AAC).\n\nDemonstrate a link between the Alpha Attenuation Coefficient (AAC) measured by the NaoX measurement tool and the state of fatigue experienced.\n\nEndpoint: significant increase in Karolinska Sleepiness Scale (KSS) score associated with a significant decrease in Alpha Attenuation Coefficient (AAC).\n\nExperimental scheme:\n\n3 cycles of 2 recordings with the NaoX measurement tool associated with a self-questionnaire and vigilance tests (approximately 30 minutes per recording), carried out before and after a night shift by a medical resident.\n\nPopulation targeted:\n\nMedical residents performing night shifts of at least 12 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers.\n* Male, female.\n* Medical residents.\n* Aged between 24 and 34 years.\n* Doing emergency, intensive care or "inside" shifts.\n* Working in a health institution.\n* No history of epilepsy.\n* No background treatment that could have an impact on the EEG (electroencephalogram) data (type: benzodiazepines, anti-epileptics).\n* No significant change in background treatment during the study, if any.\n* Affiliation to the social security system.\n* Informed volunteer who has signed a consent form.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05531734', 'acronym': 'MOTIVATES', 'briefTitle': 'MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT', 'orgStudyIdInfo': {'id': 'APHP220576'}, 'secondaryIdInfos': [{'id': '2022-A01959-34', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'volunteers', 'description': 'Health volunteers', 'interventionNames': ['Device: NaoX Intra-Auricular Device (IAD) monitoring EEG data', 'Behavioral: Simple psychometric tests']}], 'interventions': [{'name': 'NaoX Intra-Auricular Device (IAD) monitoring EEG data', 'type': 'DEVICE', 'description': 'Intrauaricular measurement tool developed by NaoX Technology to retrieve EEG type data.', 'armGroupLabels': ['volunteers']}, {'name': 'Simple psychometric tests', 'type': 'BEHAVIORAL', 'description': 'Associated with simple and self-managed psychometric tests.', 'armGroupLabels': ['volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'Jean BERGOUNIOUX, MD, PhD', 'role': 'CONTACT', 'email': 'jean.bergounioux@gmail.com', 'phone': '+ 33 (0)1 47 10 79 00', 'phoneExt': '41131'}, {'name': 'Clément PIERRET', 'role': 'CONTACT', 'email': 'clément.pierret@gmail.com', 'phone': '+ 33 (0)6 80 10 97 52'}], 'overallOfficials': [{'name': 'Jean BERGOUNIOUX, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}