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The goal of this feasibility study is to test the Korus smart mattress in healthy volunteers. The main questions it aims to answer are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control subjects | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control subjects | Device | The subject will be repositioned from the prone to recovery position |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body position detection | Correct detection of one of 4 cardinal body positions: prone, supine, left, right | 5 seconds |
| Number of subjects correctly repositioned from the prone to recovery position | We will measure the performance of Korus to successfully reposition the subject from the prone to recovery position | 30 seconds |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Woo Lee, MD, PhD | Contact | 617-732-7547 | jlee38@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jong Woo Lee, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24012372 | Background | Ryvlin P, Nashef L, Lhatoo SD, Bateman LM, Bird J, Bleasel A, Boon P, Crespel A, Dworetzky BA, Hogenhaven H, Lerche H, Maillard L, Malter MP, Marchal C, Murthy JM, Nitsche M, Pataraia E, Rabben T, Rheims S, Sadzot B, Schulze-Bonhage A, Seyal M, So EL, Spitz M, Szucs A, Tan M, Tao JX, Tomson T. Incidence and mechanisms of cardiorespiratory arrests in epilepsy monitoring units (MORTEMUS): a retrospective study. Lancet Neurol. 2013 Oct;12(10):966-77. doi: 10.1016/S1474-4422(13)70214-X. Epub 2013 Sep 4. | |
| 25875185 |
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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
All data will be deposited starting 12 months after the study completion
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.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Background |
| Tao JX, Sandra R, Wu S, Ebersole JS. Should the "Back to Sleep" campaign be advocated for SUDEP prevention? Epilepsy Behav. 2015 Apr;45:79-80. doi: 10.1016/j.yebeh.2015.02.020. Epub 2015 Apr 11. No abstract available. |