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EpilepsyNCT07877896

A Device to Prevent Unexpected Death in Epilepsy

A study testing Study Subjects in people with Epilepsy, run by Brigham and Women's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study has the objective to demonstrate safety and effectiveness of the Korus device in identifying body positioning. Primary Objective Validate the sensor system in Korus for body position detection using a pressure-based sensory system. Secondary Objective Efficacy in repositioning from a prone position Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
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
5 May 2022to Jul 2028
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -Adults ages 18-70, at least 30% subjects will be self-identified as prone sleepers

Who cannot join

  • History of neurological dysfunction, including spinal cord abnormalities
  • History of cardiac dysfunction
  • History of osteoporosis or osteopenia
  • History of significant orthopedic dysfunction
  • History of falls
  • History of sleep disorder
Show all 12Show fewer
  • Taking neuroactive medications that increase risk of falls or are taken to induce sleep
  • Taking anticoagulants
  • Current substance use disorder
  • BMI under 18 or over 30
  • Systolic BP >180 or <90
  • Condition for which body movements will be potentially harmful such as open wounds

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

The study has the objective to demonstrate safety and effectiveness of the Korus device in identifying body positioning.

Primary Objective Validate the sensor system in Korus for body position detection using a pressure-based sensory system.

Secondary Objective Efficacy in repositioning from a prone position

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 lie with on the Korus Smart 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. During the overnight stay, subjects may be repositioned by the mattress from the prone to the sideways recovery position.

Study groups in NCT07877896
Study groupRoleWhat they receive
Study subjectsExperimentalThe subject will lie with on the Korus Smart 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. During the overnight stay, subjects may be repositioned by the mattress from the prone to the sideways recovery position.
Receives: Device: Study Subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome

    Validate the sensor system in Korus for body position detection using a pressure-based sensory system. Prone position detection >95%

    Measured: Two years

Secondary outcomes (1)

  1. Secondary Outcome

    Percentage of patients successfully repositioned from a prone to recovery position >90%

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study start5 May 2022
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07877896
Sponsor's protocol ID
2021P002558
Other IDs
R44NS120394
Status last verified
Oct 2026
First submitted
24 Sep 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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

  • Sowers LP, Massey CA, Gehlbach BK, Granner MA, Richerson GB. Sudden unexpected death in epilepsy: fatal post-ictal respiratory and arousal mechanisms. Respir Physiol Neurobiol. 2013 Nov 1;189(2):315-23. doi: 10.1016/j.resp.2013.05.010. Epub 2013 May 23.

    PubMed 23707877

  • Shmuely S, Surges R, Sander JW, Thijs RD. Prone sleeping and SUDEP risk: The dynamics of body positions in nonfatal convulsive seizures. Epilepsy Behav. 2016 Sep;62:176-9. doi: 10.1016/j.yebeh.2016.06.017. Epub 2016 Aug 1.

    PubMed 27490904

  • Wang S, Graf S, Xu J, Issa NP, Ali A, Rose S, Wu S, Jacobsen J, Warnke P, Tao JX. The incidence of peri-ictal prone position in patients with generalized convulsive seizures. Epilepsy Behav. 2016 Aug;61:158-161. doi: 10.1016/j.yebeh.2016.05.033. Epub 2016 Jun 25.

    PubMed 27351726

  • Liebenthal JA, Wu S, Rose S, Ebersole JS, Tao JX. Association of prone position with sudden unexpected death in epilepsy. Neurology. 2015 Feb 17;84(7):703-9. doi: 10.1212/WNL.0000000000001260. Epub 2015 Jan 21.

    PubMed 25609764

  • 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 24012372

  • Lamberts RJ, Thijs RD, Laffan A, Langan Y, Sander JW. Sudden unexpected death in epilepsy: people with nocturnal seizures may be at highest risk. Epilepsia. 2012 Feb;53(2):253-7. doi: 10.1111/j.1528-1167.2011.03360.x. Epub 2011 Dec 22.

    PubMed 22192074

  • Ali A, Wu S, Issa NP, Rose S, Towle VL, Warnke P, Tao JX. Association of sleep with sudden unexpected death in epilepsy. Epilepsy Behav. 2017 Nov;76:1-6. doi: 10.1016/j.yebeh.2017.08.021. Epub 2017 Sep 13.

    PubMed 28917499

  • Massey CA, Sowers LP, Dlouhy BJ, Richerson GB. Mechanisms of sudden unexpected death in epilepsy: the pathway to prevention. Nat Rev Neurol. 2014 May;10(5):271-82. doi: 10.1038/nrneurol.2014.64. Epub 2014 Apr 22.

    PubMed 24752120

  • Devinsky O, Friedman D, Cheng JY, Moffatt E, Kim A, Tseng ZH. Underestimation of sudden deaths among patients with seizures and epilepsy. Neurology. 2017 Aug 29;89(9):886-892. doi: 10.1212/WNL.0000000000004292. Epub 2017 Aug 2.

    PubMed 28768851

  • Chen Z, Brodie MJ, Liew D, Kwan P. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated With Established and New Antiepileptic Drugs: A 30-Year Longitudinal Cohort Study. JAMA Neurol. 2018 Mar 1;75(3):279-286. doi: 10.1001/jamaneurol.2017.3949.

    PubMed 29279892

  • Doumlele K, Friedman D, Buchhalter J, Donner EJ, Louik J, Devinsky O. Sudden Unexpected Death in Epilepsy Among Patients With Benign Childhood Epilepsy With Centrotemporal Spikes. JAMA Neurol. 2017 Jun 1;74(6):645-649. doi: 10.1001/jamaneurol.2016.6126.

    PubMed 28384699

  • Devinsky O, Hesdorffer DC, Thurman DJ, Lhatoo S, Richerson G. Sudden unexpected death in epilepsy: epidemiology, mechanisms, and prevention. Lancet Neurol. 2016 Sep;15(10):1075-88. doi: 10.1016/S1474-4422(16)30158-2. Epub 2016 Aug 8.

    PubMed 27571159

  • Thurman DJ, Hesdorffer DC, French JA. Sudden unexpected death in epilepsy: assessing the public health burden. Epilepsia. 2014 Oct;55(10):1479-85. doi: 10.1111/epi.12666. Epub 2014 Jun 5.

    PubMed 24903551

  • van der Lende M, Hesdorffer DC, Sander JW, Thijs RD. Nocturnal supervision and SUDEP risk at different epilepsy care settings. Neurology. 2018 Oct 16;91(16):e1508-e1518. doi: 10.1212/WNL.0000000000006356. Epub 2018 Sep 21.

    PubMed 30242018

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 12 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome (time frame: Two years). 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 NCT07877896, which also lists 14 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 16 Oct 2026.

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A Device to Prevent Unexpected Death in Epilepsy | AzTrials