[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100372848":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":25,"locations":31,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":18,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Iowa","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Respiratory physiology testing","Subjects will wear a nosepiece and breathe through a Y-valve that allows switching from room air to two 5-liter rebreathing bags pre-filled with 50% O2, 6% CO2, and balance N2. Ventilation and respiratory gases will be measured using a pneumotachograph and rapid gas analyzers (Ultima PFX pulmonary function\u002Fstress testing system, Medical Graphics Corp). In subjects who experience clinical seizure-like activity, we will repeat the HCVR. This repeat test will occur 2 or more hours after a generalized convulsive seizure (GCS). We will repeat the HCVR at least 30 minutes after a non-GCS. Finally, we may repeat the HCVR at least 18 hours after the last seizure (GCS or non-GCS). It is anticipated that some subjects may exhibit frequent seizures that necessitate the adjustment of this schedule. Subjects may also be asked to sniff, hold their breath, and breathe through tubes of different sizes.",[12],"Other: 6% Carbon dioxide\u002F50% oxygen\u002Fbalance nitrogen mixture",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":18},"6% Carbon dioxide\u002F50% oxygen\u002Fbalance nitrogen mixture","In the hypercapnic ventilatory response (HCVR) test, the subject will rebreathe a gas mixture that has 6% carbon dioxide and 50% oxygen. This test has been performed for decades for research and clinical purposes. The effects of carbon dioxide inhalation are short lived and do not cause long term consequences. the hypercapnic ventilatory response (HCVR), we will have you",[9],null,[20,23],{"name":21,"affiliation":5,"role":22},"Brian Gehlbach, MD","PRINCIPAL_INVESTIGATOR",{"name":24,"affiliation":5,"role":22},"George Richerson, MD, PhD",[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Study Coordinator","CONTACT","319-356-4337","dragond@healthcare.uiowa.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University of Iowa Hospitals and Clinics","RECRUITING","Iowa City","Iowa","52242","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-91.53017,41.66113,{"lat":44,"lon":43},[47,51,55,56],{"name":48,"role":28,"phone":49,"phoneExt":18,"email":50},"Deidre Dragon, BS","(319) 356-4337","dragond@uiowa.edu",{"name":52,"role":28,"phone":53,"phoneExt":18,"email":54},"Brian K Gehlbach, MD","319-356-3603","brian-gehlbach@uiowa.edu",{"name":21,"role":22,"phone":18,"phoneExt":18,"email":18},{"name":24,"role":22,"phone":18,"phoneExt":18,"email":18},{"type":22,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Brian Gehlbach","MD",[61],{"name":62,"class":63},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100372848","carbon-dioxide-co2-chemosensitivity-and-sudep-100372848",false,"NCT04134754","Carbon Dioxide (CO2) Chemosensitivity and SUDEP","The Role of Central CO2 Chemosensitivity in Postictal Respiratory Depression and SUDEP","Inclusion Criteria:\n\n1. The subject is between 18 and 99 years of age.\n2. Confirmed or suspected epilepsy.\n3. Admission to the EMU for spell characterization (EMU group) or undergoing care in the University of Iowa Health Care Epilepsy Clinic.\n\nExclusion Criteria:\n\n1. History of uncontrolled cardiac, pulmonary, or hepatic disease.\n2. Progressive or uncontrolled neurologic disease unrelated to epilepsy.\n3. Current opioid use.\n4. 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).\n5. Other comorbid condition that may influence the safety or feasibility of HCVR testing.\n6. Limited decision-making capacity and absence of a qualified representative.","ALL","18 Years","99 Years",{"count":75,"type":76},335,"ESTIMATED","INTERVENTIONAL",[79],"NA","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.",[82,83],"Epilepsy","SUDEP",[82],"2026-06-18",{"date":87,"type":88},"2026-06-23","ACTUAL",{"date":90,"type":88},"2019-12-12",{"date":92,"type":76},"2029-10-01",{"name":5,"class":6},1]