Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-30 @ 3:18 PM
Study NCT ID:
NCT06581133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2024-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Disruption Pattern - Epilepsy Monitoring Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'This is a single blind study and patients will not know which group they are in.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'During their epilepsy monitoring unit (EMU) admission, patients will be divided into either the alarm group or the control group. Patients in the alarm group will have an alarm system placed in their room, scheduled to sound at several timepoints during the night. This intervention will be conducted throughout the whole EMU admission. Patients in the control group will have an alarm system placed in their room, but the alarm system will not sound during any of the nights during their EMU admission.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure frequency during EMU (epilepsy monitoring unit) stay', 'timeFrame': '1 month after the EMU stay (up to 9 weeks)', 'description': "Average number of seizures per day, recorded daily during the patient's EMU stay. Measured for all groups of patients."}, {'measure': 'Duration of EMU (epilepsy monitoring unit) admission', 'timeFrame': '1 month after the EMU stay (up to 9 weeks)', 'description': 'Overall duration (in days) of the EMU admission. Measured for all groups of patients.'}, {'measure': 'Average interictal spike rates', 'timeFrame': '1 month after the EMU stay (up to 9 weeks)', 'description': 'Average number of spike rates, taken from a random segment for each day and night. Measured for all groups of patients.'}, {'measure': 'Change in sleep quality', 'timeFrame': 'Baseline (Day 1), last day of EMU stay (up to 5 weeks), 1 month after the EMU stay (up to 9 weeks)', 'description': 'As determined by changes in Pittsburgh Sleep Quality Index scores. A higher score indicates increased sleep disturbances.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epilepsy monitoring unit'], 'conditions': ['Epilepsy Intractable']}, 'descriptionModule': {'briefSummary': "Epilepsy affects millions worldwide, with 40% of patients experiencing uncontrolled seizures despite medication. Comprehensive epilepsy centers recommend continuous video-electroencephalography monitoring to define seizure type and distinguish mimickers. This process, however, is resource-intensive, with lengthy hospital stays. The investigators' recent study identified a heightened association between arousals and epileptic activity in drug-resistant focal epilepsy patients. Building on these findings, the investigators aim to explore whether disrupting sleep with an alarm system triggers earlier occurrence of seizures, potentially offering insights to reduce hospital stay durations in epilepsy monitoring units."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 14 to 60 years\n* EMU monitoring for presurgical evaluations\n* Average 2-3 seizures per week based on pre-admission seizure diary\n* Sleep as a known seizure trigger\n\nExclusion Criteria:\n\n\\- Multiple seizures a day based on pre-admission seizure diary'}, 'identificationModule': {'nctId': 'NCT06581133', 'briefTitle': 'Sleep Disruption Pattern - Epilepsy Monitoring Unit', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Introducing a Structured Sleep Disruption Pattern to Provoke Earlier Seizures During Epilepsy Monitoring Unit Admissions', 'orgStudyIdInfo': {'id': 'Pro00115255'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alarm', 'description': "Patients in the alarm group will have an alarm system placed in their room, scheduled to sound at 4 timepoints during the night (specific timepoints adjusted based on patient's preferred bed times). This intervention will stop when the clinical team has collected sufficient seizures for clinical decision making.", 'interventionNames': ['Device: Alarm system']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in the control group will have an alarm system placed in their room, but the alarm system will not sound during any of the nights during their EMU admission.'}], 'interventions': [{'name': 'Alarm system', 'type': 'DEVICE', 'description': 'Generic alarm system programmed to sound during the night to try to induce arousals from sleep.', 'armGroupLabels': ['Alarm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Birgit Frauscher, MD PD', 'role': 'CONTACT', 'email': 'birgit.frauscher@duke.edu', 'phone': '9196139386'}, {'name': 'Mays Khweileh, MD', 'role': 'CONTACT', 'email': 'mays.khweileh@duke.edu'}], 'overallOfficials': [{'name': 'Birgit Frauscher, MD PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}