Healthy
Conditions
Keywords
Carbon Dioxide, Cognitive Impairment
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. 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.
Interventions
OTHER2500 ppm Carbon Dioxide
2.5 hour exposure to 2500 ppm carbon dioxide
OTHER600 ppm Carbon Dioxide
2.5 hour exposure to 600 ppm carbon dioxide
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Basal Oxygen Consumption (OCR) | 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). |
| Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Total Stimulated Oxygen Consumption. | 4 hours after each exposure | Using blood samples collected 4 hours post-exposure, PMN activation was assessed by measurement of total stimulated oxygen consumption. |
| Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Time to Peak (TTP) Oxygen Consumption | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHoward Kipen, MD
Professor
Participant flow
Recruitment details
There were 27 participants that started the study. Of these, 26 completed the study by completing both study visits. One participant was withdrawn from the investigator due to a protocol deviation.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 21 years STANDARD_DEVIATION 2.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
None listed