Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy Intractable
• Intervention / Treatment: Device: Dreem headband

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birgit Frauscher, MD PD; Phone Number: 9196139386; Email: birgit.frauscher@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System
      • Contact: Birgit Frasucher, MD PD; Email: birgit.frauscher@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Dreem 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Birgit Frauscher, MD PD, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: sleep; epilepsy; wearable EEG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: Pro00115560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No