Carbon Dioxide (CO2) Chemosensitivity and SUDEP
Recruiting · NCT04134754 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Iowa
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
- 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.
Where it is running
2 locations listed across 1 US state.
- University of Iowa Hospitals and Clinics - Iowa City, Iowa, United States
- University of Iowa Hospitals and Clinics - Iowa City, Iowa, United States