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NCT04134754 · ClinicalTrials.gov registry record · NA
Carbon Dioxide (CO2) Chemosensitivity and SUDEP
A NA study of Epilepsy and SUDEP, sponsored by University of Iowa.
- Recruiting
- Registry status
- NA
- Development phase
- 335
- Enrollment target
- 1
- Study location
NCT04134754: Recruiting NA study of Epilepsy and SUDEP, sponsored by University of Iowa.
NCT04134754 is a NA study of Epilepsy and SUDEP that is actively recruiting participants, run by University of Iowa. The registered enrollment target is 335 participants, below the 950-participant average among 160 other Epilepsy trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04134754, a NA study of Epilepsy and SUDEP, is actively recruiting participants, sponsored by University of Iowa.
- RECRUITING
- Registry status
- NA
- Development phase
- 335 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The change in HCVR slope (change in minute ventilation \[liters/min\] vs change in end tidal CO2 \[mm Hg\]) will be correlated with the increase in transcutaneous CO2 level (mm Hg) provoked by a seizure.
Interventions
- OTHER 6% Carbon dioxide/50% oxygen/balance nitrogen mixture
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2029-10-01 |
| Phase | NA |
What NCT04134754 shows while recruiting
NCT04134754 is an interventional study that assigns participants to a tested intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap, below the 950-participant average among 160 other Epilepsy trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which 6% Carbon dioxide/50% oxygen/balance nitrogen mixture is the first listed.
NCT04134754 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT04134754 about?
NCT04134754 is a clinical study titled "Carbon Dioxide (CO2) Chemosensitivity and SUDEP". 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...
What is the current status of trial NCT04134754?
This trial is currently recruiting. It is a NA study. The enrollment target is 335 participants. The study started on 2019-12-12. Estimated completion is 2029-10-01.
What conditions does trial NCT04134754 study?
This clinical trial studies the following conditions: Epilepsy, SUDEP.
What interventions are being tested in trial NCT04134754?
The interventions under investigation include: 6% Carbon dioxide/50% oxygen/balance nitrogen mixture (OTHER).
Who is sponsoring clinical trial NCT04134754?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04134754 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04134754's enrollment target sits among peer trials
335 19th of 160 higher than 142 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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