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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: Control subjects

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jong Woo Lee, MD, PhD; Phone Number: 617-732-7547; Email: jlee38@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Control subjects; The subject will be repositioned from the prone to recovery position

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Jong Woo Lee, MD, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Ryvlin P, Nashef L, Lhatoo SD, Bateman LM, Bird J, Bleasel A, Boon P, Crespel A, Dworetzky BA, Hogenhaven H, Lerche H, Maillard L, Malter MP, Marchal C, Murthy JM, Nitsche M, Pataraia E, Rabben T, Rheims S, Sadzot B, Schulze-Bonhage A, Seyal M, So EL, Spitz M, Szucs A, Tan M, Tao JX, Tomson T. Incidence and mechanisms of cardiorespiratory arrests in epilepsy monitoring units (MORTEMUS): a retrospective study. Lancet Neurol. 2013 Oct;12(10):966-77. doi: 10.1016/S1474-4422(13)70214-X. Epub 2013 Sep 4.
• Tao JX, Sandra R, Wu S, Ebersole JS. Should the "Back to Sleep" campaign be advocated for SUDEP prevention? Epilepsy Behav. 2015 Apr;45:79-80. doi: 10.1016/j.yebeh.2015.02.020. Epub 2015 Apr 11. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Epilepsy; Sudden Unexpected Death in Epilepsy
• Other Study ID Numbers: 2023P002023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will collect and generate the following data from 50 normative control subjects: a) spontaneous body position as recorded by the KORUS sensor; b) subject demographics: age, sex, height, weight
• IPD Sharing Time Frame: All data will be deposited starting 12 months after the study completion
• IPD Sharing Access Criteria: To request access of the data, researchers will use the standard processes at PhysioNet, where the data will be stored, which will decide which requests to grant.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No