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NCT06135285Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 27 Jul 2026

Brief summary (registry, in English)

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%.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
6 Nov 2023
Start date
15 Aug 2026
Primary completion date
Jun 2027
Lead sponsor
Brigham and Women's Hospital
Diseases
Epilepsy
NCT number
NCT06135285

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 15 Aug 2026 to the primary completion date, Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients admitted for medication adjustment only

Other illness

  • Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)

Who the study is looking for

  • 1\. 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.