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NCT Number: NCT06545643

Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

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.

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Key information

Conditions

Epilepsy Intractable Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Birgit Frasucher, MD PD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dreem headband

Device

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.

Primary outcomes

  1. Total sleep time (sleep macrostructure)

    Time frame: 21 days

    Total sleep time as measured by the Dreem headband

  2. Spike rates per hour (epilepsy marker)

    Time frame: 21 days

    Spikes will be detected by the Dreem headband

  3. Seizure frequency per night (epilepsy marker)

    Time frame: 21 days

    Seizures will be detected by the Dreem headband

Secondary outcomes

  1. Sleep latency (sleep macrostructure)

    Time frame: 21 days

    Sleep latency as measured by the Dreem headband

  2. Wake after sleep onset (sleep macrostructure)

    Time frame: 21 days

    Wake after sleep onset as measured by the Dreem headband

  3. Sleep efficiency (sleep macrostructure)

    Time frame: 21 days

    Sleep efficiency as measured by the Dreem headband

  4. Sleep stage distribution (sleep macrostructure)

    Time frame: 21 days

    Sleep stage distribution as measured by the Dreem headband

  5. Sleep spindle events (sleep microstructure)

    Time frame: 21 days

    Sleep spindles (10-16 Hz; duration 0.5-3 sec) as measured by the Dreem headband

  6. Sleep slow wave events (sleep microstructure)

    Time frame: 21 days

    Slow waves (0.5-4 Hz) as measured by the Dreem headband

  7. Performance the SERI model, as measured by the area under the receiver operating characteristic curve

    Time frame: 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.

  8. Sensitivity of the SERI model

    Time frame: 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.

  9. Specificity of the SERI model

    Time frame: 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.

  10. Performance the SERI model, as measured by F1-score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Birgit Frauscher, MD PD

CONTACT

[email protected]

9196139386

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 9, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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