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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
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Carbon Dioxide, Cognitive Impairment

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 24, 2022
Last Updated
July 17, 2023
Sponsor
Rutgers, The State University of New Jersey
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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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