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NCT Number: NCT06135285

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

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%.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

This is an exploratory study with the goal of using a commercial bed sheet sensor and software with Soterya Inc's Korus software to identify GTCs in an inpatient setting.

50 patients will be monitored at the BWH EMU with the goal of capturing 20 GTCS events.

The sheet sensor used will be the Sensor Products Tactilus High Performance Mattress Sensor System with the accompanying Tactilus Software. Pressure sensor data will be processed by Soterya Inc's Korus Software. The sensor system is a piezoresistive device that is already in commercial use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Study Subjects

Device

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

Primary outcomes

  1. Body position detection

    Time frame: 5 seconds

    Correct detection of one of 4 cardinal body positions: prone, supine, left, right

  2. Number of subjects correctly repositioned from the prone to recovery position

    Time frame: 30 seconds

    We will measure the performance of Korus to successfully reposition the subject from the prone to recovery position

Study contacts

Contact information is provided by the study sponsor or research team.

Jong Woo Lee, MD, PhD

CONTACT

[email protected]

617-732-7547

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Soterya Inc.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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