About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
History of uncontrolled cardiac, pulmonary, or hepatic disease.
Progressive or uncontrolled neurologic disease unrelated to epilepsy.
Current opioid use.
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).
Trial design
Treatments tested in this trial
- 6% Carbon dioxide/50% oxygen/balance nitrogen mixture
Treatment groups
Sponsors and collaborators
University of Iowa
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator