An interventional study of Study Subjects in Epilepsy, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 1,228 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Adults ages 18-70, at least 30% subjects will be self-identified as prone sleepers
Exclusion criteria:
The subject will lie with on the Korus Smart Mattress. Subjects will initially be asked to lie in the 4 cardinal body positions (prone, supine, left, and right) to calibrate the body position recognition software. During the overnight stay, subjects may be repositioned by the mattress from the prone to the sideways recovery position.
Device: Study Subjects
The subject will lie with on the Korus Smart Mattress. Subjects will initially be asked to lie in the 4 cardinal body positions (prone, supine, left, and right) to calibrate the body position recognition software. During the overnight stay, subjects may be repositioned by the mattress from the prone to the sideways recovery position.
Primary Outcome
Validate the sensor system in Korus for body position detection using a pressure-based sensory system. Prone position detection \>95%
Time frame: Two years
Secondary Outcome
Percentage of patients successfully repositioned from a prone to recovery position \>90%
Time frame: 2 years
Plan to share: Yes — We will collect and generate the following data from 50 normative control subjects: a) spontaneous body position as recorded by the KORUS sensor; b) subject demographics: age, sex, height, weight
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: All data will be deposited starting 12 months after the study completion
Access criteria: To request access of the data, researchers will use the standard processes at PhysioNet, where the data will be stored, which will decide which requests to grant.
Started May 2022 (actual). Primary completion is estimated for Jul 2028, 74 months after the start.
Of 347 non-industry interventional studies with no phase under Epilepsy, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 78. This study's planned 74 months is above that.
Counting every sponsor, half of 371 studies reached it within 40 months; a quarter within 19 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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