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

Study Overview
=================
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.

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

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: Control subjects


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control subjects<br>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. | Device: Control subjects<br>* The subject will be repositioned from the prone to recovery position<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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