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Active, not recruitingNCT02813980NC-SUDEPUpdated Sep 11, 2026

Neural Circulatory Control and SUDEP Risk.

An observational study in Epilepsy and Seizures, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
39
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (SUDEP). SUDEP-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. This research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.

Read the detailed description

The investigators overall goals are to determine whether measures of neural-circulatory control during the interictal waking and sleep states, as well as during the ictal/peri-ictal periods, are associated with SUDEP-7 score risk profiles in refractory epilepsy patients, and to translate these measures into tools for risk-stratification and preventative strategies for SUDEP.

02

Conditions studied

  • Epilepsy
  • Seizures

Keywords

  • SUDEP
  • Sudden cardiac death
  • Sudden unexpected death in epilepsy
  • Sleep
  • Polysomnography
  • Autonomic
  • Cardiovascular
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 39 is below the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with epilepsy.

Inclusion criteria

  • Adults aged 18-90
  • Able to consent

Exclusion criteria

Exclusion Criteria:

  • History of non-epileptic spells/seizures,
  • Children/adolescents under age 18 years
  • Pregnancy
  • Non-compliance with Epilepsy Monitoring Unit safety procedures
  • Unable to consent
  • History of dysautonomia
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Asthma (active requiring therapy)
  • Pulmonary hypertension
  • Known Structural Heart Disease
  • Heart failure
  • Myocardial infarction
  • Stroke
  • Seizures due to traumatic injury
  • Prior surgery for epilepsy
  • Vasculitis
  • Raynaud's
  • Smoking (current or within the last 6 months)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
39 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • High SUDEP-7 score

    Patients with epilepsy who have a high SUDEP-7 score

  • Low SUDEP-7 score

    Patients with epilepsy who have a low SUDEP-7 score

06

What researchers measure

Primary outcomes

  1. Abnormal neural circulatory control in patients with epilepsy and high SUDEP-7 scores compared to patients with epilepsy and low SUDEP-7 scores.

    Time frame: 24 hours

  2. Abnormal neural and respiratory control in the ictal and peri-ictal phase of patients with epilepsy and a high SUDEP-7 score when compared to patients with epilepsy and a low SUDEP-7 score.

    Time frame: 3-7 days

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02813980
Lead sponsor
Mayo Clinic
Collaborators
American Heart Association
Responsible party
Virend Somers, MD, PhD (PI, Mayo Clinic) — Principal investigator
First posted
Jun 27, 2016
Start date
Jun 2016
Primary completion
Dec 2031 (estimated)
Completion
Dec 2031 (estimated)
Last update
Sep 11, 2026

Study contacts

Virend K Somers, MD PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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