A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position

Starting soon · Not applicable

Conditions studied: Epilepsy

In brief

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%.

Key facts

Study ID

NCT06135285

Run by

Brigham and Women's Hospital

People needed

50

Starts

2026-08-15

Expected to finish

2027-06-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)
• Patients admitted for medication adjustment only

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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