EpilepsyNCT06135285
A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position
A study testing Study Subjects in people with Epilepsy, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Study Subjects
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)
- Patients admitted for medication adjustment only
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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%.
Read the detailed description
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.
- Conditions
- Epilepsy
- Being tested
- Study Subjects
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study SubjectsDevice
The subject will be monitored as they lie on the Tactilus Bodyfitter sensor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Study Subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body position detection
Correct detection of one of 4 cardinal body positions: prone, supine, left, right
Measured: 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
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Aug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Soterya Inc.
- Responsible party
- Principal investigator, Jong Woo Lee, Brigham and Women's Hospital
- Investigators
- Jong Woo Lee, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135285
- Sponsor's protocol ID
- 2026P001165
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will collect and generate the following data from 50 normative control subjects: a) spontaneous body position as recorded by the KORUS sensor; b) subject demographics: age, sex, height, weight
Publications
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.
PubMed 24012372Tao 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.
PubMed 25875185
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position
- ClinicalTrials.gov ID
- NCT06135285
- Acronym / sponsor ID
- 2026P001165
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Soterya Inc.
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study subjects | Experimental | Device: Study SubjectsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)
- Patients admitted for medication adjustment only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study SubjectsThe subject will be monitored as they lie on the Tactilus Bodyfitter sensor. | Device | Study subjects |
Primary outcome
Body position detection
Time frame: 5 seconds
Correct detection of one of 4 cardinal body positions: prone, supine, left, right
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 24012372Ryvlin 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.
- Background: PubMed 25875185Tao 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.
- Individual participant dataSharing planned: Yes. We will collect and generate the following data from 50 normative control subjects: a) spontaneous body position as recorded by the KORUS sensor; b) subject demographics: age, sex, height, weight
Related trials for Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jong Woo Lee, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Subjects in people with Epilepsy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong Woo Lee, MD, PhD (617-732-7547, jlee38@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body position detection (time frame: 5 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135285, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.