A device to prevent sudden unexpected death in epilepsy (sudep)

Ended Project Grant Awarded Last action

Award ID
R43NS120394
Recipient
Awarding agency
Obligated
$1,507,683

Award facts

Completion date
Originally
Funding
  • $1,005,122.00 Federal
  • $502,561.00 Non-federal
Place of performance
Everett, MA 02149, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Sudden unexpected death in epilepsy (sudep) is the leading cause of death in epilepsy children and otherwise healthy adult epilepsy patients, with a cumulative lifetime risk of ~8%. About 70% of sudep occurs during sleep, and nearly 90% are found in the prone (face-down) position. Sudep can likely be prevented by the simple intervention of repositioning and stimulating the patient after a convulsive seizure. Such intervention must be performed quickly and autonomously within a critical 3-minute window after a convulsion. Soterya, INC., founded with the mission to develop technologies to decrease the risk of sudep, addresses this critical unmet medical need with an innovative smart mattress, the korus. Soterya has demonstrated feasibility by developing a functional alpha prototype consisting of an array of expandable cells and a shapeable surface that safely and rapidly repositions human subjects. There are currently no products that detects the prone position and physically repositions a patient into a recovery (sideways) position. The goal of this phase i sbir is to develop and validate two key technologies required to successfully develop a fully functional autonomous prototype: 1) advanced expandable cell with the size, weight, safety features, and noise management suitable for a human clinical trial, while maintaining our benchmark of generating enough lift at a required velocity with a 1000 LB/cell capacity; 2) embedded sensor system for rapid detection of body position change, and detection of the prone position. Soterya will optimize sensor manufacturing capabilities and software tools for body positioning visualization and data processing, and develop software for integrating these tools into a single sensory network system. Human feasibility testing will be performed through our academic partners at the epilepsy and sleep medicine service of the brigham and women's hospital. A total of 10 normative control subjects will be recruited to test the device efficacy in repositioning, awake testing to assess detection of body position changes, and overnight testing for detecting spontaneous body position changes during sleep. Milestones for this study will be 1) safely repositioning subjects from a prone to a recovery position within 30 seconds; 2) detecting body position changes into a prone position with 95% accuracy. The completion of this project will position soterya for the development of a fully functional prototype. A subsequent phase 2 study will pair the korus with a commercial seizure detection device for a clinical trial in the hospital epilepsy monitoring unit, with the ultimate goal of developing a fully embedded seizure detection and management system. The development of korus as a medical device for the night-time management of convulsive seizures will achieve a 50-75% risk reduction of night-time sudep.

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $502,561 $0
Original award $502,561 $502,561

Quick answers

Who received award R43NS120394?

R43NS120394 was awarded to Soterya, Inc. by National Institute of Neurological Disorders and Stroke (National Institutes of Health) on September 21, 2021.

How much is award R43NS120394 worth?

$1,507,683 has been obligated on R43NS120394: $1,005,122 in federal funding and $502,561 in non-federal funding.

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