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

NCT06135285 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026P001165
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Body position detection

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

  5 seconds

• Number of subjects correctly repositioned from the prone to recovery position

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

  30 seconds

Study Arms (1)

Study subjects

EXPERIMENTAL

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.

Device: Study Subjects

Interventions

Study Subjects DEVICE

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

Study subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Soterya Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Ryvlin P, Nashef L, Lhatoo SD, Bateman LM, Bird J, Bleasel A, Boon P, Crespel A, Dworetzky BA, Hogenhaven H, Lerche H, Maillard L, Malter MP, Marchal C, Murthy JM, Nitsche M, Pataraia E, Rabben T, Rheims S, Sadzot B, Schulze-Bonhage A, Seyal M, So EL, Spitz M, Szucs A, Tan M, Tao JX, Tomson T. Incidence and mechanisms of cardiorespiratory arrests in epilepsy monitoring units (MORTEMUS): a retrospective study. Lancet Neurol. 2013 Oct;12(10):966-77. doi: 10.1016/S1474-4422(13)70214-X. Epub 2013 Sep 4.

  PMID: 24012372 BACKGROUND

• Tao JX, Sandra R, Wu S, Ebersole JS. Should the "Back to Sleep" campaign be advocated for SUDEP prevention? Epilepsy Behav. 2015 Apr;45:79-80. doi: 10.1016/j.yebeh.2015.02.020. Epub 2015 Apr 11. No abstract available.

  PMID: 25875185 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jong Woo Lee, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Woo Lee, MD, PhD

CONTACT

617-732-7547; jlee38@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 18, 2023
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All data will be deposited starting 12 months after the study completion
• Access Criteria: To request access of the data, researchers will use the standard processes at PhysioNet, where the data will be stored, which will decide which requests to grant.

Locations

US (1)