← Back to all trials
Recruiting
NCT06545643
Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
Conditions: Epilepsy Intractable
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Duke University
Location: Duke University Health System Durham North Carolina
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
Source: ClinicalTrials.gov (NCT06545643). StuddyBuddy aggregates publicly available trial information.