A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position (NCT06135285) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position
United States50 participantsStarted 2026-08-15
Plain-language summary
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%.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)
. Patients admitted for medication adjustment only
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing a device designed to detect body position and reposition someone from face-down to a recovery position during a seizure, can you explain how a device like this might realistically reduce my personal risk of SUDEP, and how significant that risk is for me specifically?
2This trial hasn't started recruiting yet — do you know roughly when it might open, and would it be worth revisiting as an option once enrollment begins?
3The trial seems focused on whether the device can correctly detect prone positioning and physically reposition someone — since it's not yet in a phase testing long-term safety or effectiveness in real seizure situations, what unknowns should I keep in mind if I consider joining once it opens?
4Are there existing strategies — like seizure monitors, supervised sleeping arrangements, or medication adjustments — that might address my SUDEP risk in the meantime while this trial is still in development?
5Since this device would likely be used during sleep or unwitnessed seizures, how would participation affect my daily life and home setup, and is that something my household would realistically be able to manage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body position detection
Timeframe: 5 seconds
2
Number of subjects correctly repositioned from the prone to recovery position