Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
Recruiting now · Not applicable
Conditions studied: Epilepsy Intractable
In brief
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.
Key facts
- Study ID
- NCT06545643
- Run by
- Duke University
- People needed
- 35
- Starts
- 2025-05-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Duke University Health System — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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