Carbon Dioxide (CO2) and Cognitive Impairment
Primary Purpose
Healthy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2500 ppm Carbon Dioxide
600 ppm Carbon Dioxide
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Carbon Dioxide, Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- History of COVID-19 vaccination
- Weigh at least 110 pounds
Exclusion Criteria:
- Colorblindness
- Inability to hear verbal instructions
- Cardiovascular disease, including a history of stroke
- Diabetes requiring the use of insulin
- Pregnancy
- Current asthma (an asthma attack within the past five years)
- Medications for or history of anxiety disorder diagnosis or panic attacks
- Medications which may affect cognition such as beta-blockers and CNS depressants
Temporary Exclusion Criteria
- Respiratory symptoms in the previous four weeks
- Use of sedating cold/allergy medications in the previous week
- Use of marijuana in the previous week
- Consumption of alcohol in the previous 24 hours
Sites / Locations
- Rutgers - EOHSIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
High CO2 Exposure first, then low CO2 exposure second.
Low CO2 Exposure first, then high CO2 exposure second.
Arm Description
At the first study visit the subject is exposed to 2500 ppm CO2 for 2.5 hours and at the second study visit the subject is exposed to 600 ppm CO2 for 2.5 hours.
At the first study visit the subject is exposed to 600 ppm CO2 for 2.5 hours and at the second study visit the subject is exposed to 2500 ppm CO2 for 2.5 hours.
Outcomes
Primary Outcome Measures
Change in PMN (polymorphonuclear leukocyte) activation from pre-exposure to post-exposure
Using blood samples collected pre- and post-exposure, PMN activation will be assessed by measurement of oxidative burst (oxygen consumption rate), glycolytic function (extracellular acidification rate) and caspase-1 activity (assessed by fluorometric assay).
Secondary Outcome Measures
Full Information
NCT ID
NCT05292378
First Posted
January 24, 2022
Last Updated
July 17, 2023
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT05292378
Brief Title
Carbon Dioxide (CO2) and Cognitive Impairment
Official Title
Carbon Dioxide (CO2): A Pilot Study of a Hypothesized Mechanism to Explain Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to better understand the biological mechanisms of carbon dioxide (CO2)-induced cognitive impairments.
Detailed Description
Participants will complete 2 study visits. Each study visit will consist of a 2.5-hour exposure session. Concentrations of CO2 during the exposure session will be either 600 ppm (control) or 2500 ppm (exposure). The order of the exposure sessions will be randomized and the exposure sessions will be at least one week apart. Up to two participants will take part in each exposure session.
During each exposure a neurobehavioral assessment (Strategic Management Simulations or SMS) will be administered. Venous blood (30 mL) will be collected from subjects immediately before entering the chamber and immediately after the exposure. A subset of subjects (n=12) will also undergo a 60-minute fMRI scan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Carbon Dioxide, Cognitive Impairment
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High CO2 Exposure first, then low CO2 exposure second.
Arm Type
Experimental
Arm Description
At the first study visit the subject is exposed to 2500 ppm CO2 for 2.5 hours and at the second study visit the subject is exposed to 600 ppm CO2 for 2.5 hours.
Arm Title
Low CO2 Exposure first, then high CO2 exposure second.
Arm Type
Sham Comparator
Arm Description
At the first study visit the subject is exposed to 600 ppm CO2 for 2.5 hours and at the second study visit the subject is exposed to 2500 ppm CO2 for 2.5 hours.
Intervention Type
Other
Intervention Name(s)
2500 ppm Carbon Dioxide
Intervention Description
2.5 hour exposure to 2500 ppm carbon dioxide
Intervention Type
Other
Intervention Name(s)
600 ppm Carbon Dioxide
Intervention Description
2.5 hour exposure to 600 ppm carbon dioxide
Primary Outcome Measure Information:
Title
Change in PMN (polymorphonuclear leukocyte) activation from pre-exposure to post-exposure
Description
Using blood samples collected pre- and post-exposure, PMN activation will be assessed by measurement of oxidative burst (oxygen consumption rate), glycolytic function (extracellular acidification rate) and caspase-1 activity (assessed by fluorometric assay).
Time Frame
Immediately before and immediately after each exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of COVID-19 vaccination
Weigh at least 110 pounds
Exclusion Criteria:
Colorblindness
Inability to hear verbal instructions
Cardiovascular disease, including a history of stroke
Diabetes requiring the use of insulin
Pregnancy
Current asthma (an asthma attack within the past five years)
Medications for or history of anxiety disorder diagnosis or panic attacks
Medications which may affect cognition such as beta-blockers and CNS depressants
Temporary Exclusion Criteria
Respiratory symptoms in the previous four weeks
Use of sedating cold/allergy medications in the previous week
Use of marijuana in the previous week
Consumption of alcohol in the previous 24 hours
Additional Exclusion Criteria for Subjects undergoing the fMRI scan:
History of head trauma or neurosurgery or neurological disorder
Ferrous metal implanted in or on the body, electrical devices such as a pacemaker, nonremovable ferrous jewelry
Surgical pins or plates above the neck
History of eye injury involving metallic materials, shavings in eyes, or welding without a face mask
Lead or iron tatoos
Claustrophobia
Back problems that would prevent the subject from laying still comfortably for up to 90 minutes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Black, PhD
Phone
848-445-6049
Email
kgblack@eohsi.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Legard
Phone
848-445-6086
Email
abl104@eohsi.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Kipen, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers - EOHSI
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Black, PhD
Phone
848-445-6049
Email
kgblack@eohsi.rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Learn more about this trial
Carbon Dioxide (CO2) and Cognitive Impairment
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