Carbon Dioxide (CO2) Chemosensitivity and SUDEP

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT04134754
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • 6% Carbon dioxide/50% oxygen/balance nitrogen mixture — OTHER
    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

Study Details

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.

Key Dates

Start date
Dec 12, 2019
Status verified
Mar 2025
Primary completion
Oct 1, 2029
Completion
Oct 1, 2029

Study Design

Enrollment
335 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: 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/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.

Primary Outcome Measure

Determine the correlation between baseline central CO2 chemosensitivity and the increase in transcutaneous CO2 levels after a seizure. [ Time Frame: Immediately before and after a seizure, variable for each subject but approximately 10 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Deidre Dragon, BS
[email protected]
(319) 356-4337
Brian K Gehlbach, MD
[email protected]
319-356-3603
Brian Gehlbach, MD (PRINCIPAL_INVESTIGATOR)
George Richerson, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
University of Iowa Hospitals and Clinics· Iowa City, IA

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