[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558017":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":47,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":19,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dreem headband","EXPERIMENTAL","Participants will wear a Fitbit daily and a Dreem headband exclusively at night in their homes over a 21-day period as part of the data collection protocol. Additionally, they will maintain daily sleep and seizure diaries.",[13],"Device: Dreem headband",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The Dreem headband is an EEG-based wearable tool that can be used to reliably assess the relationship between sleep and epilepsy over extended observation periods.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Birgit Frauscher, MD PD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","9196139386","birgit.frauscher@duke.edu",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Duke University Health System","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-78.89862,35.99403,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":19,"phoneExt":19,"email":28},"Birgit Frasucher, MD PD",{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100558017","sleep-sensitive-seizure-risk-assessment-with-wearable-eegs-100558017",false,"NCT06545643","Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs","Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices","Inclusion Criteria:\n\n* Age \\> 18 years\n* At least 2 seizures per week based on clinical notes\n* Patients where medications will stay stable over the study period\n* 40% of both spikes and spindles are identifiable on the dreem headband based on the screening night\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Psychiatric comorbidities which may influence sleep\n* No bedpartner\u002Fcaregiver to observe seizures\n* Low agreement (below 60%) between Dreem's sleep scoring and manual scoring will be excluded from the study\n* Apnea-hypopnea index of \\> 10\u002Fh","ALL","18 Years",{"count":59,"type":60},35,"ESTIMATED","INTERVENTIONAL",[63],"NA","Epilepsy, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. Sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. Studies conducted in hospital settings provide only brief observation periods and fail to capture the natural sleep environment. Wearable technology offers a promising solution, providing a nuanced understanding of the relationship between seizures and sleep. The Dreem headband, an EEG-based wearable, is well-suited for such studies, offering ease of use and validated accuracy. This technology enables extended observation periods under stable medication conditions, essential for assessing the complex interplay between sleep and epilepsy. By elucidating the impact of sleep on seizures, the researchers seek to identify patient populations where sleep significantly influences seizure susceptibility, ultimately informing personalized epilepsy treatments.",[66],"Epilepsy Intractable",[68,69,70],"epilepsy","sleep","wearable EEG","2026-06-04",{"date":73,"type":74},"2026-06-05","ACTUAL",{"date":76,"type":74},"2025-05-01",{"date":78,"type":60},"2028-06-01",{"name":5,"class":6},1]