RECRUITING

Carbon Dioxide (CO2) Chemosensitivity and SUDEP

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Conditions

EpilepsySUDEP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-12-12
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04134754

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The subject is between 18 and 99 years of age.
  2. 2. Confirmed or suspected epilepsy.
  3. 3. Admission to the EMU for spell characterization (EMU group) or undergoing care in the University of Iowa Health Care Epilepsy Clinic.
  1. 1. History of uncontrolled cardiac, pulmonary, or hepatic disease.
  2. 2. Progressive or uncontrolled neurologic disease unrelated to epilepsy.
  3. 3. Current opioid use.
  4. 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. 5. Other comorbid condition that may influence the safety or feasibility of HCVR testing.
  6. 6. Limited decision-making capacity and absence of a qualified representative.

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
319-356-4337
dragond@healthcare.uiowa.edu

Principal Investigator

Brian Gehlbach, MD
PRINCIPAL_INVESTIGATOR
University of Iowa
George Richerson, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: University of Iowa

  • Brian Gehlbach, MD, PRINCIPAL_INVESTIGATOR, University of Iowa
  • George Richerson, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-12
Study Completion Date2029-10

Study Record Updates

Study Start Date2019-12-12
Study Completion Date2029-10

Terms related to this study

Keywords Provided by Researchers

  • Epilepsy

Additional Relevant MeSH Terms

  • Epilepsy
  • SUDEP