Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Sleep-friendly Seizure Risk with Wearable EEGs

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

Run by Duke University · NCT06545643 · Data updated 2026-11-12

This study tests whether a wearable EEG headband can help predict seizure risk related to sleep in adults with epilepsy whose seizures are not well controlled.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment35 (estimated)
SponsorDuke University
Academic / other
Locations1 site (Durham, North Carolina)
StatusRecruiting
StartedMay 1, 2025
Main results expectedJune 1, 2027
Study endsJune 1, 2028
Registry record updatedOctober 19, 2026
Trial IDNCT06545643 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with epilepsy who have at least 2 seizures per week and whose medications will remain stable during the study, with reliable Dreem headband sleep scoring.

Probably not a fit

Patients whose seizures are not influenced by sleep or who do not meet the headband’s scoring criteria are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use the Dreem headband to monitor sleep and brain activity over extended periods while participants keep stable medications. They will analyze how sleep timing, duration, and structure relate to interictal discharges and seizure events. A new Sleep-Sensitive Epilepsy Risk Index (SERI) will be developed to predict seizure risk tied to sleep disruption. The study aims to identify which patients are most affected by sleep changes and to inform more personalized care. Data will be collected in the Duke University Health System to reflect real-world conditions.

Why it matters

Potential benefit: If successful, the approach could enable personalized sleep-based strategies to reduce seizure risk.

How similar studies have gone: Wearable EEGs have shown promise in sleep research, but this study extends the approach to predict seizure risk and develop a targeted risk index.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Duke University Health System
    Durham, North Carolina, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.