NCT06545643 Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
| NCT ID | NCT06545643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Epilepsy Intractable |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2025-05-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Birgit Frauscher, MD PD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06545643 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epilepsy Intractable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06545643 currently recruiting?
Yes, NCT06545643 is actively recruiting participants. Contact the research team at birgit.frauscher@duke.edu for enrollment information.
Where is the NCT06545643 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06545643 clinical trial?
NCT06545643 is sponsored by Duke University. The principal investigator is Birgit Frauscher, MD PD at Duke University. The trial plans to enroll 35 participants.
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