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CO2 Chemosensitivity Testing for SUDEP Risk in Epilepsy
N/A
Recruiting
Led By Brian Gehlbach, MD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed or suspected epilepsy
The subject is between 18 and 99 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying sudden unexpected death in epilepsy and will enroll subjects from the University of Iowa Hospitals and Clinics. The effects of seizures on breathing, the cardiovascular system, and arousal will be analyzed.
Who is the study for?
This trial is for adults aged 18-99 with confirmed or suspected epilepsy, either admitted to the Epilepsy Monitoring Unit (EMU) or receiving care at the University of Iowa Health Care Epilepsy Clinic. It's not suitable for those with uncontrolled heart, lung, liver diseases, progressive neurological conditions not related to epilepsy, current opioid users, pregnant women or those who could become pregnant without effective birth control.Check my eligibility
What is being tested?
The study aims to understand what causes Sudden Unexpected Death in Epilepsy (SUDEP) by examining how seizures affect breathing and arousal. Participants will inhale a special gas mixture containing carbon dioxide and oxygen while their health is monitored over ten years.See study design
What are the potential side effects?
While specific side effects are not detailed here, inhaling the gas mixture may cause discomfort like shortness of breath or dizziness due to increased CO2 levels. Long-term monitoring might identify other risks associated with seizure-related changes in breathing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have epilepsy.
Select...
I am between 18 and 99 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Seizures
Determine the correlation between baseline central CO2 chemosensitivity and the increase in transcutaneous CO2 levels after a seizure.
Epilepsy
+1 moreSecondary outcome measures
Change in respiratory rate provoked by seizures
Trial Design
1Treatment groups
Experimental Treatment
Group I: Respiratory physiology testingExperimental Treatment1 Intervention
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/stress 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.
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Who is running the clinical trial?
University of IowaLead Sponsor
447 Previous Clinical Trials
879,387 Total Patients Enrolled
Brian Gehlbach, MDPrincipal Investigator - University of Iowa
University of Iowa Chemical Dependency Center, University of Iowa Hospitals & Clinics
Washington University School Of Medicine (Medical School)
University Of Chicago Hosps (Residency)
George Richerson, MD, PhDPrincipal InvestigatorUniversity of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who could become pregnant and have not used effective birth control recently.I do not have any uncontrolled heart, lung, or liver diseases.I have difficulty making decisions and do not have someone to help me.I have epilepsy.You have other health conditions that could make it unsafe or difficult to do the testing for HCVR.I am between 18 and 99 years old.I am currently using opioids.My neurological condition is worsening and not due to epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Respiratory physiology testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to partake in this research endeavor?
"Admission to this research initiative is contingent on the candidate having aura and residing within the specified age range of 18-99 years. Currently, 335 people are being sought after for participation."
Answered by AI
Are there any vacancies in this clinical trial for participants?
"Affirmative. According to the clinicaltrials.gov website, this research project is actively in search of participants and was initially posted on December 12th 2019 with a most recent update occurring June 6th 2022. The study requires 335 individuals from one medical facility."
Answered by AI
How many participants are contributing to this research endeavor?
"That is indeed the case. According to clinicaltrials.gov, this medical study, which was first announced on December 12th 2019, remains open for recruitment and has recently been updated on June 6th 2022. It aims to enrol 335 patients from 1 particular location."
Answered by AI
Does this clinical research allow for those over fifty to participate?
"This medical trial requires that patients are between 18 and 99 years of age. For those under the age of 18, there are 103 studies available while 156 exist for individuals over 65."
Answered by AI
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