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NOT YET RECRUITING
NCT06135285
NA

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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%.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-08-15

Completion Date

2027-06

Last Updated

2026-07-27

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Study Subjects

The subject will be monitored as they lie on the Tactilus Bodyfitter sensor.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States