Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
- Conditions
- Epilepsy Intractable
- Interventions
- Device: Dreem headband
- Registration Number
- NCT06545643
- Lead Sponsor
- Duke University
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dreem headband 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 Measures
Name Time Method Spike rates per hour (epilepsy marker) 21 days Spikes will be detected by the Dreem headband
Total sleep time (sleep macrostructure) 21 days Total sleep time as measured by the Dreem headband
Seizure frequency per night (epilepsy marker) 21 days Seizures will be detected by the Dreem headband
- Secondary Outcome Measures
Name Time Method Sleep latency (sleep macrostructure) 21 days Sleep latency as measured by the Dreem headband
Sleep efficiency (sleep macrostructure) 21 days Sleep efficiency as measured by the Dreem headband
Sleep stage distribution (sleep macrostructure) 21 days Sleep stage distribution as measured by the Dreem headband
Sleep spindle events (sleep microstructure) 21 days Sleep spindles (10-16 Hz; duration 0.5-3 sec) as measured by the Dreem headband
Sleep slow wave events (sleep microstructure) 21 days Slow waves (0.5-4 Hz) as measured by the Dreem headband
Performance the SERI model, as measured by the area under the receiver operating characteristic curve Up to 2 years after study commencement The Sleep-Sensitive Epilepsy Risk Index (SERI) aims to predict an individual's seizure risk associated with disrupted sleep. A high SERI will indicate a high risk for sleep-sensitive seizures, while a low value will indicate a low risk.
Wake after sleep onset (sleep macrostructure) 21 days Wake after sleep onset as measured by the Dreem headband
Specificity of the SERI model Up to 2 years after study commencement The Sleep-Sensitive Epilepsy Risk Index (SERI) aims to predict an individual's seizure risk associated with disrupted sleep. A high SERI will indicate a high risk for sleep-sensitive seizures, while a low value will indicate a low risk.
Performance the SERI model, as measured by F1-score Up to 2 years after study commencement The Sleep-Sensitive Epilepsy Risk Index (SERI) aims to predict an individual's seizure risk associated with disrupted sleep. A high SERI will indicate a high risk for sleep-sensitive seizures, while a low value will indicate a low risk.
The F1 score ranges from 0 to 1. A value of 0 indicates poor performance, and a value of 1 represents perfect performance.Sensitivity of the SERI model Up to 2 years after study commencement The Sleep-Sensitive Epilepsy Risk Index (SERI) aims to predict an individual's seizure risk associated with disrupted sleep. A high SERI will indicate a high risk for sleep-sensitive seizures, while a low value will indicate a low risk.
Trial Locations
- Locations (1)
Duke University Health System
🇺🇸Durham, North Carolina, United States