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

Mass General Brigham

Status: Not yet enrolling

Conditions: Epilepsy

Treatments: Device: Control subjects

Study type: Interventional

Funder types: Other

Identifiers

NCT06135285

2023P002023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Control subjects

Experimental group

Description:

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.

Treatment:

Device: Control subjects