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

35 Participants Needed

Trial Summary

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 data supports the effectiveness of the Dreem headband treatment for epilepsy?

The research suggests that wearable EEG devices, like the Dreem headband, can help accurately monitor seizures outside of the hospital, which is beneficial for people with epilepsy. These devices are generally well-received by patients for their comfort and usability, and they can improve the quality of life by reducing seizure underreporting. ^{1 2 3 4 5}

Is the wearable EEG device safe for humans?

The research on wearable devices for epilepsy management, including EEGs, suggests they are generally safe for human use. Patients have reported these devices as comfortable and acceptable for routine use, although improvements in data quality and consistency are still needed. ^{2 3 4 5 6}

How does the Dreem headband treatment for epilepsy differ from other treatments?

The Dreem headband is a wearable EEG device that allows for long-term, noninvasive monitoring of brain activity, making it unique compared to traditional bulky EEG systems. It enables patients to go about their daily lives while providing continuous data collection, which can improve the accuracy of seizure monitoring and diagnosis. ^{1 3 4 7 8}

What is the purpose of this trial?

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.

Research Team

Birgit Frauscher, MD PD

Principal Investigator

Duke University

Eligibility Criteria

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.

I experience at least 2 seizures per week.

My medications will not change during the study.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Day and night comfort and stability on the body of four wearable devices for seizure detection: A direct user-experience. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Electrographic seizure monitoring with a novel, wireless, single-channel EEG sensor. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Signal quality and patient experience with wearable devices for epilepsy management. [2021]

5. Italy pubmed.ncbi.nlm.nih.gov

Wearable seizure detection devices in refractory epilepsy. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Patients self-mastery of wearable devices for seizure detection: A direct user-experience. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Wearable electroencephalography. What is it, why is it needed, and what does it entail? [2010]

8. Switzerland pubmed.ncbi.nlm.nih.gov

PreEpiSeizures: description and outcomes of physiological data acquisition using wearable devices during video-EEG monitoring in people with epilepsy. [2023]