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Active Not Recruiting
NCT07877896
A Device to Prevent Unexpected Death in Epilepsy
Conditions: Epilepsy
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
The study has the objective to demonstrate safety and effectiveness of the Korus device in identifying body positioning.
Primary Objective Validate the sensor system in Korus for body position detection using a pressure-based sensory system.
Secondary Objective Efficacy in repositioning from a prone position
Eligibility Criteria
Inclusion criteria:
-Adults ages 18-70, at least 30% subjects will be self-identified as prone sleepers
Exclusion criteria:
* History of neurological dysfunction, including spinal cord abnormalities
* History of cardiac dysfunction
* History of osteoporosis or osteopenia
* History of significant orthopedic dysfunction
* History of falls
* History of sleep disorder
* Taking neuroactive medications that increase risk of falls or are taken to induce sleep
* Taking anticoagulants
* Current substance use disorder
* BMI under 18 or over 30
* Systolic BP \>180 or \
Source: ClinicalTrials.gov (NCT07877896). StuddyBuddy aggregates publicly available trial information.