Sleep-Sensitive Seizure Risk Assessment with Wearable EEGs

This study is looking at how sleep affects seizures in people with intractable epilepsy (seizures that are hard to control with medicine). Researchers are using a wearable device called the Dreem headband, which measures brain activity (EEG), to understand the connection between sleep patterns and seizure risk over 21 days. The goal is to see how changes in your sleep might lead to seizures and to create a way to predict your individual risk for sleep-sensitive seizures. You might be able to join if you are over 18, have at least two seizures per week, and your medications will stay stable during the study. The study will measure your total sleep time, how often certain brain waves (spikes) occur, and how often you have seizures each night.

Study design
This interventional study plans to enroll 35 participants to investigate the relationship between sleep and seizures using a wearable device.
What's involved
Participants will use the Dreem headband for an extended observation period of 21 days.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study are taken at 21 days.

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NCT06545643

Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

Recruiting
NAAges 18+InterventionalScreening
Duke University
~35 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Dreem headband

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total sleep time (sleep macrostructure)
Measured over 21 days
+2 more outcomes measured
Epilepsy Intractable
1 sites across 1 states
North Carolina1
  • Birgit Frauscher, MD PD · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

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

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
  • Total sleep time (sleep macrostructure)21 days

    Total sleep time as measured by the Dreem headband

  • Spike rates per hour (epilepsy marker)21 days

    Spikes will be detected by the Dreem headband

  • Seizure frequency per night (epilepsy marker)21 days

    Seizures will be detected by the Dreem headband