Understanding the causes of Sudden Unexpected Death in Epilepsy
Official title: The Role of Central CO2 Chemosensitivity in Postictal Respiratory Depression and SUDEP
Run by University of Iowa · NCT04134754 · Data updated 2026-11-12
This study is trying to understand why some people with epilepsy suddenly die by looking at how seizures affect their breathing and heart function over ten years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 335 (estimated) |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Status | Recruiting |
| Started | December 12, 2019 |
| Main results expected | October 1, 2029 |
| Study ends | October 1, 2029 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT04134754 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 99 with confirmed or suspected epilepsy who are admitted to the Epilepsy Monitoring Unit for evaluation.
✕Probably not a fit
Patients with uncontrolled cardiac, pulmonary, or hepatic diseases, or those with other significant comorbid conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research focuses on investigating the causes of Sudden Unexpected Death in Epilepsy (SUDEP) by analyzing the effects of seizures on breathing, cardiovascular function, and arousal. Adults with confirmed or suspected epilepsy will be enrolled from the University of Iowa Hospitals and Clinics' Epilepsy Monitoring Unit. Participants will undergo noninvasive cardiorespiratory monitoring and respiratory tests, including a hypercapnic ventilatory response test, to assess their breathing response to elevated carbon dioxide levels. The study aims to correlate these physiological responses with seizure activity over a ten-year follow-up period.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and prevention strategies for SUDEP in patients with epilepsy.
How similar studies have gone: While studies on SUDEP and respiratory responses exist, this specific approach focusing on carbon dioxide sensitivity is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The subject is between 18 and 99 years of age. 2. Confirmed or suspected epilepsy. 3. Admission to the EMU for spell characterization (EMU group) or undergoing care in the University of Iowa Health Care Epilepsy Clinic. Exclusion Criteria: 1. History of uncontrolled cardiac, pulmonary, or hepatic disease. 2. Progressive or uncontrolled neurologic disease unrelated to epilepsy. 3. Current opioid use. 4. 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). 5. Other comorbid condition that may influence the safety or feasibility of HCVR testing. 6. Limited decision-making capacity and absence of a qualified representative.
Where it's running
-
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States Recruiting
Study contacts
- Principal investigator: Brian Gehlbach, MD — University of Iowa
- Study coordinator: Study Coordinator
- Email: dragond@healthcare.uiowa.edu
- Phone: 319-356-4337
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.