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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor: Brigham and Women's Hospital
Study ID: NCT06135285
Status: Not Yet Recruiting

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Conditions

Epilepsy

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Study Subjects — DEVICE
The subject will be monitored as they lie on the Tactilus Bodyfitter sensor.

Study Details

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 Dates

First listed: Nov 18, 2023
Start date: Aug 15, 2026
Status verified: Jul 2026
Primary completion: Jun 30, 2027
Completion: Jun 30, 2027

Study Design

Enrollment: 50 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Arms

Experimental: Study subjects
The subject will lie with the Tactilus Bodyfitter on their mattress. Subjects will initially be asked to lie in the 4 cardinal body positions (prone, supine, left, and right) to calibrate the body position recognition software. Subjects will be monitored for the rest of their EMU which will be performed as usual.