Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06545643
Status
Recruiting
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Conditions

  • Epilepsy Intractable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dreem headband — DEVICE
    The Dreem headband is an EEG-based wearable tool that can be used to reliably assess the relationship between sleep and epilepsy over extended observation periods.

Study Details

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 Dates

Start date
May 1, 2025
Status verified
Jun 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Dreem headband
    Participants will wear a Fitbit daily and a Dreem headband exclusively at night in their homes over a 21-day period as part of the data collection protocol. Additionally, they will maintain daily sleep and seizure diaries.

Primary Outcome Measure

Total sleep time (sleep macrostructure) [ Time Frame: 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Health SystemDurhamNorth Carolina27710
Birgit Frasucher, MD PD
[email protected]

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By research site
Duke University Health System· Durham, NC

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