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Can a simple breathing test predict sudden death in epilepsy?
NCT ID NCT04134754
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aims to understand why some people with epilepsy die suddenly (SUDEP). Researchers will measure how well patients sense carbon dioxide in their blood and how seizures affect breathing and heart function. 335 adults with epilepsy will be followed for up to 10 years. The goal is to find links between breathing problems during seizures and SUDEP risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 6% carbon dioxide/50% oxygen/balance nitrogen mixture
- What this could lead to
- If successful, this could help identify epilepsy patients at higher risk for SUDEP and guide future prevention strategies.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly change patient care, and results may take years to translate into clinical practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 335 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Iowa Hospitals and Clinics
RECRUITINGIowa City, Iowa, 52242, United States
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- Can video games rewire young brains after injury?
- High-Fat Diet's effect on epilepsy: scientists track brain signals
- Epilepsy drug candidate put to the test in healthy volunteers