Carbon Dioxide (CO2) and Cognitive Impairment

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Recruiting

CT.gov ID

NCT05292378

Collaborator

(none)

Enrollment

Location

Arms

6.6

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: 2500 ppm Carbon Dioxide Other: 600 ppm Carbon Dioxide	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 14, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High CO2 Exposure first, then low CO2 exposure second. 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.	Other: 2500 ppm Carbon Dioxide 2.5 hour exposure to 2500 ppm carbon dioxide Other: 600 ppm Carbon Dioxide 2.5 hour exposure to 600 ppm carbon dioxide
Sham Comparator: Low CO2 Exposure first, then high CO2 exposure second. 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.	Other: 2500 ppm Carbon Dioxide 2.5 hour exposure to 2500 ppm carbon dioxide Other: 600 ppm Carbon Dioxide 2.5 hour exposure to 600 ppm carbon dioxide

Arm

Intervention/Treatment

Experimental: High CO2 Exposure first, then low CO2 exposure second.

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.

Other: 2500 ppm Carbon Dioxide

2.5 hour exposure to 2500 ppm carbon dioxide

Other: 600 ppm Carbon Dioxide

2.5 hour exposure to 600 ppm carbon dioxide

Sham Comparator: Low CO2 Exposure first, then high CO2 exposure second.

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.

Other: 2500 ppm Carbon Dioxide

2.5 hour exposure to 2500 ppm carbon dioxide

Other: 600 ppm Carbon Dioxide

2.5 hour exposure to 600 ppm carbon dioxide

Outcome Measures

Primary Outcome Measures

Change in PMN (polymorphonuclear leukocyte) activation from pre-exposure to post-exposure [Immediately before and immediately after each 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers - EOHSI	Piscataway	New Jersey	United States	08854

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

Principal Investigator: Howard Kipen, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Howard M. Kipen, MD, MPH, Professor, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT05292378

Other Study ID Numbers:

Pro2021001570

First Posted:

Mar 23, 2022

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Howard M. Kipen, MD, MPH, Professor, Rutgers, The State University of New Jersey

Carbon Dioxide

Cognitive Impairment

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Jul 21, 2022