Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
NCT Number: NCT06545643
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Epilepsy Intractable
Interventions: DEVICE: Dreem headband
Sponsor: Duke University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08-01
Completion Date: 2027-12-01

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.

Primary Outcome Measures: Total sleep time (sleep macrostructure), Total sleep time as measured by the Dreem headband, 21 days|Spike rates per hour (epilepsy marker), Spikes will be detected by the Dreem headband, 21 days|Seizure frequency per night (epilepsy marker), Seizures will be detected by the Dreem headband, 21 days
Secondary Outcome Measures: Sleep latency (sleep macrostructure), Sleep latency as measured by the Dreem headband, 21 days|Wake after sleep onset (sleep macrostructure), Wake after sleep onset as measured by the Dreem headband, 21 days|Sleep efficiency (sleep macrostructure), Sleep efficiency as measured by the Dreem headband, 21 days|Sleep stage distribution (sleep macrostructure), Sleep stage distribution as measured by the Dreem headband, 21 days|Sleep spindle events (sleep microstructure), Sleep spindles (10-16 Hz; duration 0.5-3 sec) as measured by the Dreem headband, 21 days|Sleep slow wave events (sleep microstructure), Slow waves (0.5-4 Hz) as measured by the Dreem headband, 21 days|Performance the SERI model, as measured by the area under the receiver operating characteristic curve, 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., Up to 2 years after study commencement|Sensitivity of the SERI model, 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., Up to 2 years after study commencement|Specificity of the SERI model, 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., Up to 2 years after study commencement|Performance the SERI model, as measured by F1-score, 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., Up to 2 years after study commencement