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Behavioural Intervention
Wearable EEGs for Epilepsy
N/A
Waitlist Available
Led By Birgit Frauscher, MD PD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Age \> 18 years
* At least 2 seizures per week based on clinical notes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after study commencement
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the relationship between sleep and epilepsy in patients with uncontrolled seizures. Previous studies have limitations, but wearable technology like the Dreem headband offers a solution by providing accurate and continuous
Who is the study for?
This trial is for adults over 18 with epilepsy who have at least two seizures per week and are on a stable medication regimen. Participants must also show identifiable spikes and spindles in their sleep patterns when using the Dreem headband during a screening night.
What is being tested?
The study tests the Dreem headband, an EEG-based wearable device designed to monitor brain activity during sleep. It aims to understand how sleep affects seizure risk in epilepsy patients by providing extended observation periods outside of hospital settings.
What are the potential side effects?
Since the intervention involves only wearing a non-invasive EEG headband, there are minimal expected side effects. However, some discomfort or skin irritation from prolonged wear might occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Select...
I experience at least 2 seizures per week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after study commencement
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after study commencement
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Seizure frequency per night (epilepsy marker)
Spike rates per hour (epilepsy marker)
Total sleep time (sleep macrostructure)
Secondary study objectives
Performance the SERI model, as measured by F1-score
Performance the SERI model, as measured by the area under the receiver operating characteristic curve
Sensitivity of the SERI model
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dreem headbandExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,512 Total Patients Enrolled
12 Trials studying Epilepsy
31,639 Patients Enrolled for Epilepsy
Birgit Frauscher, MD PDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
475 Total Patients Enrolled
2 Trials studying Epilepsy
475 Patients Enrolled for Epilepsy