Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545643
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalized Risk Assessment of Seizures Sensitive to Poor Sleep a Longitudinal Study Using Wearable Electroencephalography Devices
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 individuals seizure risk associated with disrupted sleep facilitating personalized and preventative patient care
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 individuals seizure risk associated with disrupted sleep facilitating personalized and preventative patient care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None