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Carbon Dioxide (CO2) Chemosensitivity and SUDEP

The Role of Central CO2 Chemosensitivity in Postictal Respiratory Depression and SUDEP

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years
  • Procedures mentioned: Heart tracing (ECG), Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects will be followed for ten years after enrollment to monitor their health."
  • "Patients admitted to the UIHC Epilepsy Monitoring Unit (EMU) for continuous VideoEEG will undergo video recordings of their face and body, electroencephalography (EEG), and electrocardiogram (ECG) as part of their normal clinical care."
  • "All subjects will agree to undergo an interview in person or by phone, email, or questionnaire annually for ten years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how seizures affect breathing, the heart and blood vessels, and the ability to wake up to better understand sudden unexpected death in epilepsy (SUDEP). It also studies the ability to sense high carbon dioxide (CO2) levels when breathing is impaired. It is for adults with confirmed or suspected epilepsy getting care at the University of Iowa, and it will follow their health for 10 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 99 years old.
  • You have epilepsy or may have epilepsy.
  • You are admitted to the University of Iowa Epilepsy Monitoring Unit to learn what causes your episodes, or you get care at its Epilepsy Clinic.

Who can't join

  • You have a history of heart, lung, or liver disease that is not under control.
  • You have a brain or nerve disease unrelated to epilepsy that is getting worse or is not under control.
  • You currently use opioid drugs.
  • You are pregnant or could become pregnant, such as having sex in the past 21 days without highly effective birth control or having a positive urine pregnancy test.
  • You have another health condition that could make testing your breathing response to CO2 unsafe or hard to do.
  • You have limited ability to make decisions and no qualified person to act for you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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, 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.

Study sites (1)

IA