Status:
NOT_YET_RECRUITING
Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
Lead Sponsor:
Duke University
Conditions:
Epilepsy Intractable
Eligibility:
All Genders
18+ years
Phase:
NA
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 suf...
Detailed Description
The first aim of this study is to investigate how variations in sleep timing, duration, and structure influence seizure risk, particularly in individuals with sleep-sensitive seizures. The investigato...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06545643
Start Date
May 1 2026
End Date
June 1 2028
Last Update
December 16 2025
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710