Smart Mattress Device for Epilepsy Prevention

(Korus Trial)

Overseen By Jong Woo Lee, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Neuroactive, Anticoagulants

Disqualifiers: Neurological, Cardiac, Orthopedic, Sleep, others

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

Compensation: Varies

Number of Visits: 1

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking neuroactive medications or anticoagulants, you cannot participate in this trial. The protocol does not specify about other medications.

What data supports the effectiveness of the treatment Korus in the Smart Mattress Device for Epilepsy Prevention trial?

The research highlights the development of advanced devices for epilepsy that can detect and track seizures accurately, which is crucial for optimizing treatments. While not directly about Korus, these technologies show promise in improving epilepsy management, suggesting potential benefits for treatments like Korus when integrated with such devices. ^{1 2 3 4 5}

Is the Smart Mattress Device for Epilepsy Prevention safe for humans?

The Mayo Epilepsy Personal Assistant Device (EPAD) system, which includes a similar concept of monitoring and adaptive stimulation, has undergone extensive testing in animals and is currently in a human trial, indicating a focus on safety. Additionally, wearable devices like the Epi-Care have been used by patients for up to six years with only mild side effects, such as skin irritation, suggesting that similar monitoring devices are generally safe for human use. ^{5 6 7 8 9}

How does the Smart Mattress Device for Epilepsy Prevention differ from other treatments for epilepsy?

The Smart Mattress Device for Epilepsy Prevention is unique because it uses a quasi-piezoelectric material to detect rhythmic motor activity during sleep, providing an early warning for generalized convulsions. This under-mattress device offers a novel approach to potentially prevent sudden unexpected death in epilepsy (SUDEP) by alerting caregivers to assist patients during nocturnal seizures, unlike traditional treatments that do not focus on sleep-related seizure detection. ^{1 3 4 10 11}

What is the purpose of this trial?

The goal of this feasibility study is to test the Korus smart mattress in healthy volunteers. The main questions it aims to answer are: * Can Korus accurately detect body position in bed (left, right, supine, prone) * Can Korus reposition the subject from a prone to recovery (sideways) position? Participants will be asked to lie down on Korus and turn into various positions; when the prone position is detected, they will be repositioned.

Research Team

Jong Woo Lee, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for healthy adults aged 18-65 who often sleep on their stomachs. It's not suitable for those with neurological, psychiatric, cardiac issues, bone diseases like osteoporosis, significant orthopedic problems, a history of falls or sleep disorders. People on certain medications or drugs and those with extreme body weights or blood pressure are also excluded.

Inclusion Criteria

I usually sleep on my stomach.

Exclusion Criteria

I have been diagnosed with osteoporosis or osteopenia.

I am taking medication that affects my brain function.

I am currently taking blood thinners.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

Participants lie down on the Korus smart mattress to test its ability to detect body position and reposition from prone to recovery position

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects or feedback after testing the device

1 week

Treatment Details

Interventions

• Korus

Trial Overview The Korus study tests a smart mattress designed to prevent SUDEP by detecting the user's sleeping position and automatically repositioning them from prone (face down) to sideways if necessary. Participants will simulate various sleeping positions to assess the device's accuracy and functionality.

Participant Groups

Group I: Control subjects Experimental Treatment 1 Intervention

The subject will lie down on the Korus smart mattress. Korus will detect when the subject is in a prone (face-down) position and reposition the subject into a recovery (sideways) position.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

The Mayo Epilepsy Personal Assistant Device (EPAD) is designed to enhance seizure prediction and management by integrating with the Medtronic Summit RC+STM device for real-time monitoring of brain activity, which could improve the effectiveness of neuromodulation therapy.

The EPAD system is currently undergoing a first-in-human trial involving ten patients with difficult-to-treat epilepsy, following extensive testing on canines, indicating a strong commitment to safety and regulatory compliance in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. Pal Attia, T., Crepeau, D., Kremen, V., et al.[2022]

In a study evaluating four non-EEG seizure monitoring systems for a patient with focal epilepsy, the Emfit mat demonstrated the highest sensitivity (78%) and low false detection rate (0.55 per night), making it the most effective choice for home monitoring.

While some devices showed promising results, they often missed specific seizure types, highlighting the need for personalized assessments and a comprehensive database to guide the selection of monitoring systems based on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical evaluation of four different seizure detection systems tested on one patient with focal and generalized tonic and clonic seizures. Van de Vel, A., Verhaert, K., Ceulemans, B.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Distributed brain co-processor for tracking spikes, seizures and behaviour during electrical brain stimulation. [2023]

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

Intracranial EEG Validation of Single-Channel Subgaleal EEG for Seizure Identification. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[A vest-pocket instrument for the detection and treatment of the onset of epileptic seizures]. [2005]

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

An electroencephalographic recording platform for real-time seizure detection. [2020]

5. 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]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. [2022]

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

Critical evaluation of four different seizure detection systems tested on one patient with focal and generalized tonic and clonic seizures. [2019]

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

Sleep-Related Epilepsy. [2020]

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

User-based evaluation of applicability and usability of a wearable accelerometer device for detecting bilateral tonic-clonic seizures: A field study. [2018]

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

Assessment of a quasi-piezoelectric mattress monitor as a detection system for generalized convulsions. [2013]

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

A novel portable seizure detection alarm system: preliminary results. [2011]