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

NCT ID: NCT06135285

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-06-30

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Control subjects

Intervention Type: DEVICE

The subject will be repositioned from the prone to recovery position

Interventions

Control subjects

The subject will be repositioned from the prone to recovery position

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jong Woo Lee

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jong Woo Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Jong Woo Lee, MD, PhD

Role: CONTACT

jlee38@bwh.harvard.edu

617-732-7547

References

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.

Reference Type: BACKGROUND

PMID: 24012372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25875185 (View on PubMed)

Other Identifiers

2023P002023

Identifier Type: -

Identifier Source: org_study_id