A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Study Subjects.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this study is to assess the performance of a commercial sheet sensor in determining body position after generalized tonic-clonic (GTC) seizures. If a sheet sensor could accurately detect GTC seizures, this could be a step towards autonomously repositioning patients with the aid of a smart mattress. Primary Objective Milestones: Feasibility objective: Monitor 50 patients with the objective of capturing at least 20 GTCS events. Primary analytic objective: Achieve detection of anatomical landmarks with body position change within 5 seconds with an accuracy of 75% both interictally and post-GTCS. Secondary Objective Detect the postictal prone position with an accuracy of 100%.
Detailed description
This is an exploratory study with the goal of using a commercial bed sheet sensor and software with Soterya Inc's Korus software to identify GTCs in an inpatient setting.
50 patients will be monitored at the BWH EMU with the goal of capturing 20 GTCS events.
The sheet sensor used will be the Sensor Products Tactilus High Performance Mattress Sensor System with the accompanying Tactilus Software. Pressure sensor data will be processed by Soterya Inc's Korus Software. The sensor system is a piezoresistive device that is already in commercial use.
Interventions
- Device Study Subjects
The subject will be monitored as they lie on the Tactilus Bodyfitter sensor.
Primary outcome measures
- Body position detection [Time frame: 5 seconds]
- Number of subjects correctly repositioned from the prone to recovery position [Time frame: 30 seconds]
Eligibility criteria
Inclusion criteria
1\. Adults 18 years of age or older admitted to the BWH EMU with drug-resistant epilepsy, defined by the failure of at least two anti-seizure medications and a documented history of electroclinical seizures
Exclusion criteria
- Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)
- Patients admitted for medication adjustment only
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Publications
- 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 retrospe PMID 24012372
- 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. PMID 25875185
Identifiers
NCT: NCT06135285 · 2026P001165