Clinical trial NCT06545643: Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
Official title: Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy Intractable
Keywords: epilepsy
sleep
wearable EEG
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total sleep time (sleep macrostructure)
timeFrame: 21 days
measure: Spike rates per hour (epilepsy marker)
timeFrame: 21 days
measure: Seizure frequency per night (epilepsy marker)
timeFrame: 21 days
Secondary outcomes:
measure: Sleep latency (sleep macrostructure)
timeFrame: 21 days
measure: Wake after sleep onset (sleep macrostructure)
timeFrame: 21 days
measure: Sleep efficiency (sleep macrostructure)
timeFrame: 21 days
measure: Sleep stage distribution (sleep macrostructure)
timeFrame: 21 days
measure: Sleep spindle events (sleep microstructure)
timeFrame: 21 days
measure: Sleep slow wave events (sleep microstructure)
timeFrame: 21 days
measure: Performance the SERI model, as measured by the area under the receiver operating characteristic curve
timeFrame: Up to 2 years after study commencement
measure: Sensitivity of the SERI model
timeFrame: Up to 2 years after study commencement
measure: Specificity of the SERI model
timeFrame: Up to 2 years after study commencement
measure: Performance the SERI model, as measured by F1-score
timeFrame: Up to 2 years after study commencement
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Birgit Frauscher, MD PD
role: PRINCIPAL_INVESTIGATOR
References: