Carbon Dioxide (CO2): A Pilot Study of a Hypothesized Mechanism to Explain Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Basal Oxygen Consumption (OCR)
研究概览
简要总结
The purpose of the study is to better understand the biological mechanisms of carbon dioxide (CO2)-induced cognitive impairments.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of COVID-19 vaccination
- •Weigh at least 110 pounds
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 2500 ppm Carbon Dioxide (Other)
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.
干预措施: 600 ppm Carbon Dioxide (Other)
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.
干预措施: 2500 ppm Carbon Dioxide (Other)
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.
干预措施: 600 ppm Carbon Dioxide (Other)
结局指标
主要结局
Change in PMN (Polymorphonuclear Leukocyte) Activation as Measured by Basal Oxygen Consumption (OCR)
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Howard M. Kipen, MD, MPH
Professor
Rutgers, The State University of New Jersey