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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smart mattress called Korus to determine if it can aid in epilepsy prevention by detecting and altering sleeping positions. The mattress identifies when a person sleeps face-down (prone) and attempts to shift them to a safer sideways position. The trial seeks participants who typically sleep face-down but do not have serious health issues like heart problems or sleep disorders. Healthy adults who often sleep on their stomachs may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance sleep safety for many.

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 prior data suggests that the Korus smart mattress is safe for use in healthy volunteers?

Research has shown that the Korus smart mattress can quickly detect and change a person's sleeping position. In one study, the mattress identified changes in body position within 5 seconds and adjusted the person from lying face-down to a safer sideways position. This feature aims to reduce the risk of sudden unexpected death in people with epilepsy.

For safety, researchers tested the mattress with healthy volunteers, and no reports of harm or side effects emerged from these trials. The quick-response feature seeks to keep users safe by automatically repositioning them, potentially preventing dangerous situations during sleep.

Overall, tests indicate that the Korus smart mattress is well-tolerated. The technology focuses on improving safety without causing discomfort or harm to the user. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for epilepsy, which often involves medication or surgery, the Korus smart mattress offers a non-invasive approach by using technology to prevent seizures. This device detects when a person is in a prone position, which can be dangerous for individuals with epilepsy, and automatically repositions them to a safer sideways position. Researchers are excited about this trial because it explores a potential new way to reduce seizure-related risks without the side effects associated with traditional treatments.

What evidence suggests that the Korus smart mattress is effective for epilepsy prevention?

Research shows that the Korus smart mattress accurately detects a person's sleeping position with 97.3% accuracy. This capability is crucial because it can adjust a person's position if they are lying face down, potentially reducing the risk of Sudden Unexpected Death in Epilepsy (SUDEP). Some studies suggest that using Korus could lower the risk of SUDEP by 50-75%. In this trial, participants will use the Korus smart mattress, which automatically adjusts sleepers to improve breathing and prevent issues from prolonged positions. While these results are promising, they primarily highlight the mattress's ability to detect and adjust positions, which may enhance nighttime safety for individuals with conditions like epilepsy. ^{2 3 5 6 7}

Who Is on the Research Team?

Jong Woo Lee, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. medrxiv.org medrxiv.org/content/10.1101/2024.01.02.23300653v1.full.pdf

A Device to Prevent Night-time Sudden Unexpected Death ... The overarching goal of this study is to develop a night-time seizure management system centered around an autonomous body repositioning ...

2. medstartr.com medstartr.com/project/detail/201890

Korus: Autonomous Sleep Care Korus revolutionizes patient care by autonomously repositioning individuals during sleep to ensure optimal breathing and reduce risks associated with immobility ...

3. medrxiv.org medrxiv.org/content/10.1101/2024.01.02.23300653v1

A Device to Prevent Night-time Sudden Unexpected Death ... In long-term studies including sleep, Korus detected the correct position during 97.3% of the time during the recording.

4. epilepsyalarms.co.uk epilepsyalarms.co.uk/the-korus-mattress-a-game-changer-in-the-fight-against-sudep/

The Korus Mattress: A Game-Changer in the Fight Against ... Korus is expected to significantly decrease the risk of night-time SUDEP by an impressive 50-75%. How does it work? The mattress is fitted with ...

5. smartpatients.com smartpatients.com/trials/NCT06135285

Korus: a Device to Prevent Sudden Unexpected Death in ... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06135285

Korus: a Device to Prevent Sudden Unexpected Death in ... Korus will utilize specialized sensors and a computer learning algorithm to detect the subject's body position. Based on this data, Korus will activate the ...

7. medstartr.com medstartr.com/project/detail/201890-Autonomous-Sleep-Care

Korus: Autonomous Sleep Care For epilepsy patients, Korus's quick-response mechanism can shift a person from a prone to a safer position, potentially decreasing SUDEP risks.