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

Epilepsy Clinical Trial

— Korus  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06135285
• Other study ID #: 2023P002023
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: June 2027

Study information

• Verified date: November 2023
• Source: Brigham and Women's Hospital
• Contact: Jong Woo Lee, MD, PhD
• Phone: 617-732-7547
• Email: jlee38[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Control subjects
The subject will be repositioned from the prone to recovery position

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body position detection	Correct detection of one of 4 cardinal body positions: prone, supine, left, right	5 seconds
Primary	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