The purpose of this research study is to better understand what causes Sudden Unexpected Death in Epilepsy (SUDEP). This study will enroll subjects from the University of Iowa Hospitals and Clinics (UIHC) Epilepsy Monitoring Unit (EMU) and Epilepsy Clinics. The investigators will analyze the effects of seizures on breathing, on the cardiovascular system, and on arousal. The investigators are studying these effects because some cases of SUDEP might be due, in part, to an inability to wake up or sense elevated carbon dioxide (CO2) levels when breathing is impaired. Subjects will be followed for ten years after enrollment to monitor their health.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject is between 18 and 99 years of age.
. Confirmed or suspected epilepsy.
. Admission to the EMU for spell characterization (EMU group) or undergoing care in the University of Iowa Health Care Epilepsy Clinic.
Exclusion criteria
. History of uncontrolled cardiac, pulmonary, or hepatic disease.
. Progressive or uncontrolled neurologic disease unrelated to epilepsy.
. Current opioid use.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring how my brain responds to CO2 levels during and after seizures — could you explain what CO2 chemosensitivity means for someone with epilepsy, and why a weaker response might be connected to SUDEP risk?
2Since this trial isn't testing a treatment but is instead observing my breathing and CO2 patterns around seizures, what does participation actually involve day-to-day, and would I need to have a seizure in a monitored setting for the measurements to be taken?
3The study tracks something called the HCVR slope over time — how many visits or monitoring sessions would that likely require, and is that a realistic commitment given my current situation?
4Since this is a non-treatment observational study, would the findings from my participation give me or my care team any useful information about my own SUDEP risk, or is the data only used for the broader research?
5Given that SUDEP is the focus here, is there anything about my current seizure type, frequency, or history that would make it especially worth discussing whether joining this study is a good fit for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the correlation between baseline central CO2 chemosensitivity and the increase in transcutaneous CO2 levels after a seizure.
Timeframe: Immediately before and after a seizure, variable for each subject but approximately 10 minutes
2
Determine the correlation between baseline central CO2 chemosensitivity and the duration of transcutaneous CO2 elevation above baseline after a seizure.
Timeframe: Duration of hospital admission, approximately 5 days
3
Effect of seizures on HCVR slope (liters/min/mm Hg)
Timeframe: Up to 18 hours after a seizure.
4
Determine the stability of the HCVR slope over time in patients with epilepsy. of the HCVR over time in patients with epilepsy
. Women of child-bearing potential who are pregnant or capable of becoming pregnant (e.g. sexual activity within the past 21 days without a highly effective form of birth control or positive urine pregnancy test).
. Other comorbid condition that may influence the safety or feasibility of HCVR testing.
. Limited decision-making capacity and absence of a qualified representative.