Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-12 @ 2:45 PM
Study NCT ID:
NCT05059002
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2021-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004830', 'term': 'Epilepsy, Tonic-Clonic'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of video-EEG to EpiWatch Results for PPA', 'timeFrame': '6 months', 'description': 'Lower bound of 95% confidence interval of the positive percent agreement (PPA) \\> 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.'}, {'measure': 'Comparison of video-EEG to EpiWatch results for FAR', 'timeFrame': '6 months', 'description': 'Upper bound of 95% confidence interval of the false alarm rate (FAR) \\<.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.'}], 'secondaryOutcomes': [{'measure': 'Pediatric Ambulation Positive Percent Agreement', 'timeFrame': '6 months', 'description': 'Estimate the PPA in pediatric participants in ambulation in addition to at rest'}, {'measure': 'Pediatric Ambulation False Alarm Rate', 'timeFrame': '6 months', 'description': 'Estimate the False Alarm Rate in pediatric participants in ambulation in addition to rest'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Seizure Detection', 'Seizure', 'Digital Health'], 'conditions': ['Epilepsy, Tonic-Clonic']}, 'descriptionModule': {'briefSummary': 'To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).', 'detailedDescription': "To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU).\n\nEligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to a site EMU for video-EEG monitoring\n* Age five and older at the time of enrollment\n* Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures\n* Willing and able to comply with study procedures\n\nExclusion Criteria:\n\n* Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors\n* Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch\n* Inability or unwillingness to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT05059002', 'briefTitle': 'EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System', 'organization': {'class': 'INDUSTRY', 'fullName': 'EpiWatch, Inc.'}, 'officialTitle': 'EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System', 'orgStudyIdInfo': {'id': 'EPW001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Monitored Subjects', 'description': 'Single arm study of subjects that have been issued an EpIWatch', 'interventionNames': ['Device: Physiological signal monitoring and seizure detection']}], 'interventions': [{'name': 'Physiological signal monitoring and seizure detection', 'type': 'DEVICE', 'description': 'Data collection and as an adjunct to other methods of seizure monitoring', 'armGroupLabels': ['Monitored Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Gregory L Krauss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EpiWatch, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}