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

NCT06135285 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-27

No results posted yet for this study

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%.

Conditions

Interventions

DEVICE

Study Subjects

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

Sponsors & Collaborators

  • Soterya Inc.

    collaborator UNKNOWN

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Jong Woo Lee, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06135285 on ClinicalTrials.gov