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Completed

NCT Number: NCT05292378

Carbon Dioxide (CO2) and Cognitive Impairment

The purpose of the study is to better understand the biological mechanisms of carbon dioxide (CO2)-induced cognitive impairments.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers - EOHSI

Piscataway, New Jersey, 08854, United States

About this study

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. Another subset of subjects (up to 10) will not complete the SMS during the exposures but will undergo computer-assisted intravital microscopy (CAIM) to exam the conjunctival microvasculature before and after the exposure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Additional Exclusion Criteria for Subjects undergoing CAIM

  • Current or recent contact lens use

Treatment and study plan

2500 ppm Carbon Dioxide

Other

2.5 hour exposure to 2500 ppm carbon dioxide

600 ppm Carbon Dioxide

Other

2.5 hour exposure to 600 ppm carbon dioxide

Primary outcomes

  1. Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Basal Oxygen Consumption (OCR)

    Time frame: 4 hours after each exposure

    Using blood samples collected 4 hours post-exposure, PMN activation was assessed by measurement of oxidative burst (oxygen consumption rate).

  2. Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Total Stimulated Oxygen Consumption.

    Time frame: 4 hours after each exposure

    Using blood samples collected 4 hours post-exposure, PMN activation was assessed by measurement of total stimulated oxygen consumption.

  3. Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Time to Peak (TTP) Oxygen Consumption

    Time frame: 4 hours after each exposure

    Using blood samples collected 4 hours post-exposure, PMN activation was assessed by measurement of time to peak (TTP) oxygen consumption.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Carbon Dioxide (CO2): A Pilot Study of a Hypothesized Mechanism to Explain Cognitive Impairment

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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