Carbon Dioxide (CO2) and Cognitive Impairment

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292378
• Other study ID #: Pro2021001570
• Status: Completed
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: January 25, 2024

Study information

• Verified date: February 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy

Intervention

Other:
• 2500 ppm Carbon Dioxide
2.5 hour exposure to 2500 ppm carbon dioxide
• 600 ppm Carbon Dioxide
2.5 hour exposure to 600 ppm carbon dioxide

Locations

Country	Name	City	State
United States	Rutgers - EOHSI	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Immediately before and immediately after each exposure