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

ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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%.

Eligibility criteria

Qualifiers

None

Disqualifiers

Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)

Patients admitted for medication adjustment only

Trial design

Treatments tested in this trial

  • Study Subjects

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators