Fact CheckerSign in

NCT06545643Recruiting

Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

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

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
35 (estimated)
First submitted
6 Aug 2024
Start date
1 May 2025
Primary completion date
1 Jun 2027
Lead sponsor
Duke University
Diseases
Epilepsy
NCT number
NCT06545643

What you commit to

  • Study type: Interventional
  • Planned participants: 35
  • From 1 May 2025 to the primary completion date, 1 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Cognitive impairment
  • Psychiatric comorbidities which may influence sleep
  • No bedpartner/caregiver to observe seizures

Other

  • Low agreement (below 60%) between Dreem's sleep scoring and manual scoring will be excluded from the study
  • Apnea-hypopnea index of \> 10/h

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University Health System
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.