Recruiting

Dreem Headband

Sponsor:

Duke University

Code:

NCT06545643

Conditions

Epilepsy Intractable

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dreem headband

Study Details

Brief summary:

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.

Conditions

Epilepsy Intractable

Study ID

NCT06545643

Start date

May 1, 2025

Status verified date

Jun, 2025

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Dreem headband

Participants will wear a Fitbit daily and a Dreem headband exclusively at night in their homes over a 21-day period as part of the data collection protocol. Additionally, they will maintain daily sleep and seizure diaries.

Interventions

Dreem headband

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 outcome measure

  • Total sleep time (sleep macrostructure) [ Time Frame: 21 days ]
  • Spike rates per hour (epilepsy marker) [ Time Frame: 21 days ]
  • Seizure frequency per night (epilepsy marker) [ Time Frame: 21 days ]

Central Contacts and Locations

Central contacts

Locations

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Birgit Frasucher, MD PD

birgit.frauscher@duke.edu

More Information

Sponsor

Duke University

Last update posted

Jun 5, 2026

Last verified

Jun, 2025

Keywords

  • epilepsy
  • sleep
  • wearable EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-05.