US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760, United States
NCT Number: NCT06636825
The aim of this randomized, double-blind, placebo-controlled crossover trial is to determine the effects of caffeine vs. placebo on psychomotor vigilance and carbon dioxide tolerance during graded hypercapnia.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Natick, Massachusetts, 01760, United States
Healthy and fit young adults (men and women) will participate in this study. Participants will perform two primary experimental trials on separate days, one after consuming 400 mg caffeine, and the other after consuming a non-caffeinated placebo. During each trial, participants will breathe increasing levels of inspired CO2 in a stepwise manner (0%, 2%, 4%, 6%, 8% CO2; all with 21% oxygen) during successive 12-minute stages. The endpoints of the graded hypercapnia protocol will be completion of the 8% CO2 stage, voluntary subject termination due to discomfort, or end-tidal CO2 greater than 70 mmHg. The investigators hypothesize that, compared to placebo, caffeine will lower end tidal and arterialized PCO2 and mitigate CO2-mediated decrements in psychomotor vigilance.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Volunteers breathe 0%, 2%, 4%, 6%, and 8% CO2 (with 21% O2, balance nitrogen) for 12 minutes each
400 mg caffeine capsule taken in a single dose 1 hour prior to graded hypercapnia
Placebo (microcrystalline cellulose) capsule taken in a single dose 1 hour prior to graded hypercapnia
Time frame: 60 minutes
End-tidal CO2 (mmHg)
Time frame: 60 minutes
Psychomotor vigilance (mean reaction time in s)
Time frame: 60 minutes
Time spent in graded hypercapnia protocol (minutes)
Time frame: 60 minutes
Ventilation (L/min)
Time frame: 60 minutes
Breaths per minute
Time frame: 60 minutes
Tidal volume (L)
Time frame: 60 minutes
Oxygen consumption (L/min)
Time frame: 60 minutes
Carbon dioxide release (L/min)
Time frame: 60 minutes
Heart Rate (Beats per minute)
Time frame: 60 minutes
Blood pressure (mmHg)
Time frame: 60 minutes
Profile of Mood States (AU); higher number is worse mood
Time frame: 60 minutes
pH (unitless)
Time frame: 60 minutes
Partial pressure of carbon dioxide (mmHg)
Time frame: 60 minutes
Bicarbonate (mmol/L))
Time frame: 60 minutes
Borg 0-10 Scale (higher number is more dyspnea)
Time frame: 60 minutes
Borg 0-10 Scale (higher number is more discomfort)
Time frame: 60 minutes
100mm visual analog scale (higher number is worse headache)
Time frame: 60 minutes
Plasma caffeine (ug/mL)
Time frame: 60 minutes
Plasma theobromine (ug/mL)
Time frame: 60 minutes
Plasma theophylline (ug/mL)
Time frame: 60 minutes
Plasma paraxanthine (ug/mL)
United States Army Research Institute of Environmental Medicine
Fed
Acronym: C3F
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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