Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-30 @ 6:52 AM
Study NCT ID:
NCT05794295
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2023-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Architecture & Cognition in Focal Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000161', 'term': 'Acoustic Stimulation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will not be aware of whether they have acoustic stimulation or sham stimulation. They will be asleep while they are monitored.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a parallel design with FE patients and healthy controls.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stanford Sleepiness Scale', 'timeFrame': 'participant completes over one week post EMU stay', 'description': 'Alertness Test; charts how alert a participant feels for up to 18 hours of the day for 7 days; scale is from 1-7 with higher scores meaning more sleepiness; abnormal is 4 and above'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'screening', 'description': 'used to measure quality and patterns of sleep in adults'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'screening', 'description': "subjective measure of a patient's sleepiness; scores are from 0-24 with higher scores meaning more sleepiness; abnormal is 10 and above"}, {'measure': 'Karolinska Sleepiness Scale / Sleep Diary', 'timeFrame': 'screening', 'description': 'Self-administered indication of sleepiness; scores are from 1-9 with higher scores meaning more sleepiness; abnormal is 7 and above'}, {'measure': 'Vigor Affect Visual Analog Scale', 'timeFrame': 'screening', 'description': 'self-administered assessment of mood; scores are from 0-10; depending on the question, higher score can mean more sleepiness or less sleepiness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy'], 'conditions': ['Focal Epilepsy']}, 'descriptionModule': {'briefSummary': 'Focal Epilepsy (FE) patients and healthy controls will wear an actigraph at home for one week and a home sleep study device at home for one night. Participants will then undergo two nights of testing (at least one week apart) at California Sleep Solutions (CSS) in Sacramento, CA. During the overnight stays, participants will have EEG leads placed and possibly a headband. They will undergo cognitive testing before they go to sleep and again in the morning. During one night of testing, sounds will be played in the room (acoustic stimulation). The sounds should not wake the participants.', 'detailedDescription': 'This study will investigate the interconnections between sleep physiology and cognitive deficits in FE and will provide essential pilot data for an interventional trial to characterize the comprehensive effects of AS/ES on sleep and cognition in FE. The long-term goal of this project is to leverage the connections between sleep, behavior, and neural network activity to develop and implement tailored cognitive and sleep interventions for individuals with epilepsy.\n\nAIM 1: Characterize sleep architecture patterns in Focal Epilepsy (FE) and determine the relationship to cognitive processing.\n\nAIM 2: Determine the effect of Sleep Stimulation (Acoustic and/or electrical - AS/ES) on sleep architecture patterns and cognitive processing in FE.\n\nAim 1 Hypothesis: Compared to controls, FE patients will exhibit interictal epileptiform discharges (IEDs) as well as reduced sleep spindle density and slow wave power with reduced slow wave sleep spindle oscillations (SW-SSO) coupling.\n\nAim 1 Hypothesis: Compared to controls, reduced SW-SSO coupling during sleep in FE patients will be associated with poorer memory and attention.\n\nAim 2 Hypothesis: AS/ES will exhibit greater levels of SW-SSO coupling compared to Sham Stimulation.\n\nAim 2 Hypothesis: Compared to Sham, AS will show increased connectivity on EEG, and improved memory and attention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - 40 years of age\n* Focal Epilepsy\n* Capacity to fully cooperate and follow directions\n* no other significant neurological disorders which could affect cognition\n\nExclusion Criteria:\n\n* Current use of any medications that can significantly affect cognition\n* No severe sleep apnea'}, 'identificationModule': {'nctId': 'NCT05794295', 'briefTitle': 'Sleep Architecture & Cognition in Focal Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Sleep Architecture & Cognition in Focal Epilepsy', 'orgStudyIdInfo': {'id': '2072010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acoustic Stimulation (AS)', 'description': 'Participants in this arm will be exposed to acoustic stimulation while they sleep during a night of monitoring.', 'interventionNames': ['Other: Acoustic Stimulation (AS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM Stimulation', 'description': 'Participants in this arm will not be exposed to any stimulation while they have their sleep monitored for one night.', 'interventionNames': ['Other: SHAM Stimulation']}], 'interventions': [{'name': 'Acoustic Stimulation (AS)', 'type': 'OTHER', 'description': 'Acoustic Stimulation will be administered while participants have their sleep monitored.', 'armGroupLabels': ['Acoustic Stimulation (AS)']}, {'name': 'SHAM Stimulation', 'type': 'OTHER', 'description': 'No stimulation will be administered while participants have their sleep monitored.', 'armGroupLabels': ['SHAM Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Temitayo Oyegbile-Chidi, MD', 'role': 'CONTACT', 'phone': '916-318-3111'}], 'facility': 'UC Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Temitayo Oyegbile-Chidi, MD', 'role': 'CONTACT', 'email': 'oyegbilechidi@health.ucdavis.edu', 'phone': '916-318-3111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}