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Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

NCT ID: NCT06545643

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-01

Study Completion Date

2028-06-01

Brief Summary

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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.

Detailed Description

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The first aim of this study is to investigate how variations in sleep timing, duration, and structure influence seizure risk, particularly in individuals with sleep-sensitive seizures. The investigators will conduct longitudinal EEG assessments to analyze how changes in sleep features correlate with interictal epileptiform discharge rates and seizure occurrences over time.

The second aim is to develop a sleep quality index that predicts individual risk for sleep-sensitive seizures, the Sleep-Sensitive Epilepsy Risk Index (SERI). This index aims to predict an individual's seizure risk associated with disrupted sleep, facilitating personalized and preventative patient care.

Conditions

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Epilepsy Intractable

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dreem headband

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Birgit Frauscher, MD PD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Birgit Frauscher, MD PD

Role: CONTACT

[email protected]
9196139386

Facility Contacts

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Birgit Frasucher, MD PD

Role: primary

[email protected]

Other Identifiers

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Pro00115560

Identifier Type: -

Identifier Source: org_study_id