Epilepsy Intractable
Conditions
Keywords
epilepsy, sleep, wearable EEG
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.
Interventions
DEVICEDreem headband
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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
All participants will initially undergo a screening night at a sleep lab before being equipped with a Dreem EEG headband and a Fitbit for continuous monitoring of sleep patterns and epileptic activity at home. Over 21 days, participants will wear the Fitbit daily and the Dreem headband exclusively at night as part of the data collection protocol. Additionally, participants will maintain daily sleep and seizure diaries.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total sleep time (sleep macrostructure) | 21 days | Total sleep time as measured by the Dreem headband |
| Spike rates per hour (epilepsy marker) | 21 days | Spikes will be detected by the Dreem headband |
| Seizure frequency per night (epilepsy marker) | 21 days | Seizures will be detected by the Dreem headband |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep latency (sleep macrostructure) | 21 days | Sleep latency as measured by the Dreem headband |
| Wake after sleep onset (sleep macrostructure) | 21 days | Wake after sleep onset 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. |
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTBirgit Frauscher, MD PD
PRINCIPAL_INVESTIGATORBirgit Frauscher, MD PD
Duke University
Outcome results
None listed