Neural Circulatory Control and SUDEP Risk.

Neural Circulatory and Respiratory Control in Patients With Epilepsy and the Risk of Sudden Unexpected Death.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02813980

Acronym

NC-SUDEP

Enrollment

Registered

2016-06-27

Start date

2016-06-01

Completion date

2031-12-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Seizures

Keywords

SUDEP, Sudden cardiac death, Sudden unexpected death in epilepsy, Sleep, Polysomnography, Autonomic, Cardiovascular

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Adults aged 18-90 * Able to consent

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)

Design outcomes

Primary

Measure	Time frame
Abnormal neural circulatory control in patients with epilepsy and high SUDEP-7 scores compared to patients with epilepsy and low SUDEP-7 scores.	24 hours
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.	3-7 days

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORVirend K Somers, MD PhD

Mayo Clinic

Outcome results