Wearable EEGs for Epilepsy

Overseen By Birgit Frauscher, MD PD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Psychiatric comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how sleep affects seizures in people with epilepsy using a Dreem headband. The headband, a wearable device, tracks brain activity during sleep, providing a clearer picture of seizures over time. It is ideal for individuals who experience at least two seizures per week and whose medication remains unchanged during the study. Participants will wear the headband at night, maintain a sleep and seizure diary, and wear a Fitbit during the day. The goal is to better understand the relationship between sleep and seizures, potentially leading to more personalized treatments for epilepsy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve epilepsy care.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that your medications stay stable throughout the study period.

What prior data suggests that the Dreem headband is safe for use in epilepsy studies?

Research has shown that the Dreem headband, used to monitor sleep and seizures, is safe for use. The FDA has approved the device, confirming it meets safety standards for its intended purpose. Studies have demonstrated that it accurately tracks sleep patterns and brain activity without causing harm. No reports of negative effects from wearing this headband exist. Users find it comfortable and easy to use, even for extended periods. This makes it a reliable tool for studying the connection between sleep and epilepsy. Overall, the Dreem headband is well-tolerated and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dreem headband for epilepsy because it offers a novel way to monitor seizures in real-time, right from the comfort of your home. Unlike traditional methods that often require hospital visits and bulky equipment, the Dreem headband is wearable and pairs with a Fitbit to continuously track brain activity and sleep patterns. This real-world data collection could lead to more accurate seizure tracking and personalized treatment plans, making epilepsy management more accessible and less intrusive.

What evidence suggests that the Dreem headband is effective for epilepsy?

Research shows that the Dreem headband, used by participants in this trial, effectively collects high-quality brain activity data during sleep. It tracks sleep patterns with approximately 83.5% accuracy, comparable to traditional sleep study methods. Additionally, devices like the Dreem headband have potential in detecting brain activity related to epilepsy. By effectively monitoring sleep, this technology could enhance understanding of how sleep impacts seizures, potentially leading to more personalized epilepsy treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Birgit Frauscher, MD PD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with epilepsy who have at least two seizures per week and are on a stable medication regimen. Participants must also show identifiable spikes and spindles in their sleep patterns when using the Dreem headband during a screening night.

Inclusion Criteria

I am over 18 years old.

My medications will not change during the study.

I experience at least 2 seizures per week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

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. They will also maintain daily sleep and seizure diaries.

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after the data collection period, with a focus on the performance of the SERI model and other sleep-related measures.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Dreem headband

Trial Overview The study tests the Dreem headband, an EEG-based wearable device designed to monitor brain activity during sleep. It aims to understand how sleep affects seizure risk in epilepsy patients by providing extended observation periods outside of hospital settings.

How Is the Trial Designed?

Group I: Dreem headband Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Wearable seizure detection devices (WSDDs) can significantly enhance the quality of life for epilepsy patients by improving seizure detection, which may lead to better care and potentially prevent sudden unexpected death in epilepsy.

Among the 16 WSDDs reviewed, those using accelerometry and surface electromyography showed the highest performance in detecting tonic-clonic seizures, emphasizing the need for standardized testing to improve device development and comparison.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable seizure detection devices in refractory epilepsy. Verdru, J., Van Paesschen, W.[2023]

The wearable device (Sensor Dot) demonstrated a focal seizure detection sensitivity of 52% in hospitalized patients and 23% in outpatients, indicating that while it can detect some seizures, its overall performance is limited by high false alarm rates and low predictive values.

Patient feedback showed that the device was generally well-received, but side effects led to a dropout rate, highlighting the need for improvements in both device performance and user experience for better clinical implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-hospital and home-based long-term monitoring of focal epilepsy with a wearable electroencephalographic device: Diagnostic yield and user experience. Macea, J., Bhagubai, M., Broux, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10283168/

Remote collection of electrophysiological data with brain ... In this manuscript, we survey evidence that EEG wearables provide high-quality data and review various software used for remote data collection.

2. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1392100/pdf

Case report: Nocturnal low-frequency stimulation of the ... Interictal spike counts were estimated as a proportion of spikes/Total sleep time (TST) recorded by Dreem headband for 15 days. Paradigm A.

3. aesnet.org aesnet.org/abstractslisting/portable-headband-eeg-in-the-detection-of-absence-epilepsy

portable headband eeg in the detection of absence epilepsy This study suggests headband EEG may have a role in absence epilepsy follow up as a feasible, low-cost tool for screening of ictal and interictal discharges.

4. researchgate.net researchgate.net/publication/345441648_The_Dreem_Headband_as_an_Alternative_to_Polysomnography_for_EEG_Signal_Acquisition_and_Sleep_Staging

(PDF) The Dreem Headband as an Alternative to ... Automatic Sleep Staging reached an overall accuracy of 83.5 ± 6.4% (F1 score : 83.8 ± 6.3) for the DH to be compared with an average of 86.4 ± ...

5. nature.com nature.com/articles/s44328-024-00013-y

EEG-based headset sleep wearable devices | npj Biosensing EEG-based wearables like the Dreem headband have shown potential for monitoring sleep in chronic pain patients, as preliminary findings ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7751170/

The Dreem Headband compared to polysomnography for ... This device is able to acquire EEG, heart rate, and breathing frequency and automatically analyze these signals using machine learning approach.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223539.pdf

August 18, 2023 Beacon Biosignals, Inc. Delphine Lemoine ... EEG data quality. A study was conducted to establish that EEG data quality from Dreem 3S is sufficient for manual review and scoring of data.

8. beacon.bio beacon.bio/news/beacon-biosignals-reports-novel-sleep-eeg-results-from-multiple-industry-collaborations-at-the-american-epilepsy-society-annual-meeting

Beacon Biosignals Reports Novel Sleep EEG Results from ... This study leverages Beacon's FDA-cleared Dreem 3S™ EEG headband to explore sleep disturbances in caregivers of children with LGS. The results ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725003739

Dreem headband performance in Insomnia Disorder Newer portable devices, such as the Dreem 3 headband, provide a novel opportunity to collect field-based data and have demonstrated accuracy in healthy sleepers ...

10. aasm.org aasm.org/fda-authorizes-dreem-3s-algorithm-updates/

FDA authorizes Dreem 3S algorithm updates This latest FDA authorization allows Beacon Biosignals to implement updates to the device's sleep staging algorithm without requiring a new 510(k) application.