No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 99
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
335 (estimated)
Sponsor
University of Iowa · Other
Who this trial is looking for
This trial is looking for adults with epilepsy to understand factors that might cause Sudden Unexpected Death in Epilepsy (SUDEP). Participants will be monitored for ten years to see how seizures affect their breathing and heart health.
I am admitted to the Epilepsy Monitoring Unit or receiving care at the Epilepsy Clinic.
You may not be able to join if
I have a history of uncontrolled heart, lung, or liver disease.
I have a progressive or uncontrolled neurologic disease not related to epilepsy.
I currently use opioids.
I am a woman who could become pregnant and I am either pregnant or have not used effective birth control.
I have another condition that might affect the safety of the study.
I have limited ability to make decisions and do not have a qualified representative.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 study…
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.
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Eligibility 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…
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.
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