Sleep-friendly Seizure Risk with Wearable EEGs
Official title: Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices
Run by Duke University · NCT06545643 · Data updated 2026-11-12
This study tests whether a wearable EEG headband can help predict seizure risk related to sleep in adults with epilepsy whose seizures are not well controlled.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT06545643 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with epilepsy who have at least 2 seizures per week and whose medications will remain stable during the study, with reliable Dreem headband sleep scoring.
✕Probably not a fit
Patients whose seizures are not influenced by sleep or who do not meet the headband’s scoring criteria are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will use the Dreem headband to monitor sleep and brain activity over extended periods while participants keep stable medications. They will analyze how sleep timing, duration, and structure relate to interictal discharges and seizure events. A new Sleep-Sensitive Epilepsy Risk Index (SERI) will be developed to predict seizure risk tied to sleep disruption. The study aims to identify which patients are most affected by sleep changes and to inform more personalized care. Data will be collected in the Duke University Health System to reflect real-world conditions.
Why it matters
Potential benefit: If successful, the approach could enable personalized sleep-based strategies to reduce seizure risk.
How similar studies have gone: Wearable EEGs have shown promise in sleep research, but this study extends the approach to predict seizure risk and develop a targeted risk index.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * At least 2 seizures per week based on clinical notes * Patients where medications will stay stable over the study period * 40% of both spikes and spindles are identifiable on the dreem headband based on the screening night Exclusion Criteria: * Cognitive impairment * Psychiatric comorbidities which may influence sleep * No bedpartner/caregiver to observe seizures * Low agreement (below 60%) between Dreem's sleep scoring and manual scoring will be excluded from the study * Apnea-hypopnea index of \> 10/h
Where it's running
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Duke University Health System
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Birgit Frauscher, MD PD — Duke University
- Study coordinator: Birgit Frauscher, MD PD
- Email: birgit.frauscher@duke.edu
- Phone: 9196139386
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Spatial scene memory testing for people with temporal lobe epilepsy having surgery
This project tests whether a virtual tour memory task combined with brain recordings can show how adults with temporal lobe epilepsy recognize and recall places.
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Pediatric Epilepsy Brain Mapping and Memory Study
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Understanding how the brain processes spatial information in epilepsy patients
This study is testing how the brains of epilepsy patients process spatial information to better understand navigation problems they might face.
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Mapping Epileptic Networks with MRI and iEEG
This study is testing a new way to use MRI and brain wave recordings to help people with hard-to-treat epilepsy understand their seizures better and improve their chances of successful surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.