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

Not Applicable

Not yet recruiting

• Conditions: Epilepsy
• Interventions: Device: Control subjects

• Registration Number: NCT06135285
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Study Start: 2024-07
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adults age 18-65; at least 30% of subjects will be self-identified as prone sleepers

Exclusion Criteria

any significant medical history for which body movements will potentially be harmful, including but not limited to:

• History of neurological dysfunction, including spinal cord abnormalities
• History of psychiatric disorder, including anxiety
• History of cardiac dysfunction
• History of osteoporosis or osteopenia
• History of significant orthopedic dysfunction
• History of falls
• History of sleep disorder
• Taking neuroactive medications
• Taking anticoagulants
• Current recreational drug use
• BMI under 18 or over 30
• Systolic BP >180 or <90
• Open wounds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control subjects	Control subjects	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.

Primary Outcome Measures

Name	Time	Method
Body position detection	5 seconds	Correct detection of one of 4 cardinal body positions: prone, supine, left, right
Number of subjects correctly repositioned from the prone to recovery position	30 seconds	We will measure the performance of Korus to successfully reposition the subject from the prone to recovery position

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States