Understanding the causes of Sudden Unexpected Death in Epilepsy
The Role of Central CO2 Chemosensitivity in Postictal Respiratory Depression and SUDEP
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 335 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT04134754 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with uncontrolled cardiac, pulmonary, or hepatic diseases, or those with other significant comorbid conditions may not benefit from this study.
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 performed: While studies on SUDEP and respiratory responses exist, this specific approach focusing on carbon dioxide sensitivity is relatively novel.
Eligibility criteria
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 this trial is running
Iowa City, Iowa
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.