Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

Duke University

Status: Begins enrollment this month

Conditions: Epilepsy Intractable

Treatments: Device: Dreem headband

Study type: Interventional

Funder types: Other

Identifiers

NCT06545643

Pro00115560

Details and patient eligibility

About

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.

Full 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 investigators will conduct longitudinal EEG assessments to analyze how changes in sleep features correlate with interictal epileptiform discharge rates and seizure occurrences over time.

The second aim is to develop a sleep quality index that predicts individual risk for sleep-sensitive seizures, the Sleep-Sensitive Epilepsy Risk Index (SERI). This index aims to predict an individual's seizure risk associated with disrupted sleep, facilitating personalized and preventative patient care.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Dreem headband

Experimental group

Description:

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.

Treatment:

Device: Dreem headband