Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

NCT06545643 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00115560
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

epilepsy; sleep; wearable EEG

Outcome Measures

Primary Outcomes (3)

• Total sleep time (sleep macrostructure)

  Total sleep time as measured by the Dreem headband

  21 days

• Spike rates per hour (epilepsy marker)

  Spikes will be detected by the Dreem headband

  21 days

• Seizure frequency per night (epilepsy marker)

  Seizures will be detected by the Dreem headband

  21 days

Secondary Outcomes (10)

• Sleep latency (sleep macrostructure)

  21 days

• Wake after sleep onset (sleep macrostructure)

  21 days

• Sleep efficiency (sleep macrostructure)

  21 days

• Sleep stage distribution (sleep macrostructure)

  21 days

• Sleep spindle events (sleep microstructure)

  21 days

Study Arms (1)

Dreem headband

EXPERIMENTAL

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.

Device: Dreem headband

Interventions

Dreem headband DEVICE

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.

Dreem headband

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• At least 2 seizures per week based on clinical notes
• Patients where medications will stay stable over the study period
• % of both spikes and spindles are identifiable on the dreem headband based on the screening night

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Birgit Frauscher, MD PD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Frauscher, MD PD

CONTACT

9196139386; birgit.frauscher@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will initially undergo a screening night at a sleep lab before being equipped with a Dreem EEG headband and a Fitbit for continuous monitoring of sleep patterns and epileptic activity at home. Over 21 days, participants will wear the Fitbit daily and the Dreem headband exclusively at night as part of the data collection protocol. Additionally, participants will maintain daily sleep and seizure diaries.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)