NCT06135285

Korus: a Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP)

Korus: Smart Mattress to Prevent Night-time Sudden Unexpected Death in Epilepsy (SUDEP)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Korus is a a smart mattress consisting entirely of pneumatically inflatable smartcells with embedded sensors. It is designed to detect a subject's body position an inflate the proper smartcells to reposition a subject from the prone to the recovery (sideways) position. Healthy control subjects will be recruited to test Korus' sensing system and its performance in repositioning the subject. 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 appropriate smart cells to reposition the subject.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	Control subjects	The subject will be repositioned from the prone to recovery position

Timeline

• Start date: 2026-05-15
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-11-18
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study