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Search / Trial NCT06545643

Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

Launched by DUKE UNIVERSITY · Aug 6, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Epilepsy Sleep Wearable Eeg

ClinConnect Summary

This clinical trial is studying how sleep affects seizures in people with epilepsy, particularly those who have difficulty controlling their seizures with medication. Researchers will use a special headband called the Dreem, which can record brain activity while you sleep. This technology allows them to monitor sleep patterns for longer periods in a comfortable home environment, rather than just in a hospital. By understanding the relationship between sleep and seizures, the goal is to find out if sleep issues contribute to more frequent seizures and how this information can help create personalized treatment plans for patients.

To participate in the trial, you need to be at least 18 years old and have at least two seizures a week. Your medications should remain stable throughout the study, and the Dreem headband must be able to accurately measure your brain activity. However, individuals with cognitive impairments, certain psychiatric conditions, or those who do not have someone to observe their seizures will not be eligible. If you join the study, you can expect to wear the headband while you sleep and provide information about your seizures, helping researchers gain valuable insights into how sleep influences seizure activity.

Gender

ALL

Eligibility 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

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Birgit Frauscher, MD PD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported