Status:
NOT_YET_RECRUITING
Korus: a Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP)
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 rep...
Eligibility Criteria
Inclusion
- • Adults age 18-65; at least 30% of subjects will be self-identified as prone sleepers
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06135285
Start Date
July 1 2024
End Date
June 1 2027
Last Update
November 18 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115