Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-04 @ 7:04 PM
Study NCT ID:
NCT03198494
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-10
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acoustic Stimulation for Seizure Suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-11-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful System Training', 'timeFrame': '72 hours', 'description': 'Assessment of how well participants learn to use stimulation smart-phone application and headphones, defined as the percentage of subjects with correctly maintained earphones during the first four hours of nocturnal sleep in the first days of use.'}, {'measure': 'Interictal Discharge frequency', 'timeFrame': '72 hours', 'description': 'IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG'}, {'measure': 'System Adherence', 'timeFrame': '2 months', 'description': 'Percentage of nights during which patients were compliant with the acoustic stimulation device during two months of home use (1 month control acoustic condition, 1 month 1Hz stimulation) determined weekly by patient self-report'}], 'secondaryOutcomes': [{'measure': 'System Use effect on Features of Sleep', 'timeFrame': '72 hours', 'description': 'Effect of system use on sleep features, including time spent in each stage of sleep, delta and spindle power and spatial distribution gather from EEG.'}, {'measure': 'Seizure Control', 'timeFrame': '3 months', 'description': 'Seizure frequency during control and treatment months gathered from seizure diary and IED frequency gathered from EEG (1 month baseline, 1 month sham stimulation, 1 month 1Hz stimulation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to test the feasibility and physiological effect of low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy patients. The long-term goal is to develop this protocol for daily, long-term use in a home setting, for nocturnal seizure and IED suppression', 'detailedDescription': '1. To test the feasibility of wearing an earphone system delivering acoustic stimulation during a night of sleep in adult epilepsy patients monitored in an inpatient unit.\n2. To determine the acute physiological effects of low-frequency acoustic stimulation on interictal epileptiform discharge (IED) frequency during NREM sleep in adult patients with epilepsy in an ambulatory setting.\n3. To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years old\n* Able to provide informed consent\n* MOCA ≥26\n* Fluent in English\n* Frequent nocturnal IEDs (≥ 10% of the sleep record)\n* Monitored on the adult epilepsy monitoring unit (EMU, for Aim 1 only) Additional inclusion criteria for Aim 3\n* Frequent nocturnal seizures (≥1 per week)\n\nExclusion Criteria:\n\n* Hearing impairment\n* Diagnosis of a sleep disorder (sleep apnea, periodic limb movements of sleep, or other medical conditions with frequent arousals)\n* Psychoactive medication use (other than AEDs, for example SSRIs, antipsychotics, BDZ, or stimulants)\n* Seizures ≤ 24 hours prior to study.\n* Alcohol or recreational drug use in the 24 hours prior to the study\n* BMI ≥ 30\n* MOCA \\<26\n* History of recent travel across time zones within the 1 month prior to study activities\n* Shift work for 1 month prior to study activities Additional Exclusion Criteria for Aim 3\n* No medication changes at least 1 month before study, and during 3 months of study activities'}, 'identificationModule': {'nctId': 'NCT03198494', 'briefTitle': 'Acoustic Stimulation for Seizure Suppression', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression', 'orgStudyIdInfo': {'id': '17-00698'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acoustic 1Hz Stimulation', 'description': '1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.', 'interventionNames': ['Other: Acoustic 1Hz Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Background Noise', 'description': 'Background noise applied via headphones and downloadable phone application during sleep every night.', 'interventionNames': ['Other: Sham Background Noise']}, {'type': 'NO_INTERVENTION', 'label': 'Baseline Seizure Monitoring', 'description': 'No use of sound system; Patients record seizures in a diary.'}], 'interventions': [{'name': 'Acoustic 1Hz Stimulation', 'type': 'OTHER', 'description': '1Hz acoustic pulses delivered during sleep via headphones', 'armGroupLabels': ['Acoustic 1Hz Stimulation']}, {'name': 'Sham Background Noise', 'type': 'OTHER', 'description': 'Background Noise used as a control', 'armGroupLabels': ['Sham Background Noise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Anli Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}