Influence of Caffeine on Psychomotor Vigilance and Carbon Dioxide Tolerance During Graded Hypercapnia
Completed · Not applicable · Has a placebo group
Conditions studied: Hypercapnia
In brief
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.
Key facts
- Study ID
- NCT06636825
- Run by
- United States Army Research Institute of Environmental Medicine
- People needed
- 29
- Starts
- 2023-11-09
- Expected to finish
- 2024-09-17
- Last updated by the study team
- 2024-10-15
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, age 18-45
- Body mass index 18.5-30.0 kg m-2
- Body mass 50-100 kg
- In good health as determined by the Office of Medical Support \& Oversight (OMSO) General Medical Clearance
- Perform exercise at least 2 times per week
- Willing to abstain from exercise and alcoholic beverages for 24 hours before each study visit.
- Willing to abstain from caffeine for 12 hours prior to all study visits
- Willing to abstain from caffeine for 12 hours after visits 3 and 4
- Willing to remain fasted (no food or fluid other than water) from lights out until after arrival at the laboratory the following morning on each study day (\~10 hours)
- Have supervisor approval if permanent party military or a federal employee at U.S. Army Natick Soldier System Center
You may not qualify if…
- Females who are pregnant or planning to become pregnant during the study
- Females who are surgically sterile
- History of severe adverse reaction to caffeine (e.g., headache, dizziness, diarrhea, insomnia)
- Taking dietary supplements, prescriptions, or over the counter medication, other than a contraceptive (unless approved by OMSO \& PI)
- Abnormal blood count (For example: hemoglobin (Hb) outside of the typical normal values reported by LabCorp in accordance with OMSO (Normal [Hb] Males = 12.6-17.7 g/dL; Females = 11.1-15.9 g/dL) or hematocrit (Hct) outside of the normal ranges (Normal Hct Males = 37.5-51.0%; Females = 34.0-46.6%) levels, presence of abnormal blood chemicals (hemoglobin S or sickle cell traits)
- Any history of pulmonary or cardiovascular disease
- Current diagnosis of asthma (childhood asthma with no recurrence in the last 5 years ok)
- Smokers or nicotine users (unless have quit >1 month prior)
- Current or recent respiratory tract or sinus infections (< 1 month prior)
- Current diagnosis of migraine or recurrent headaches (previous diagnosis with no recurrence in the last 5 years ok)
- Any history of seizures
- Any history of panic disorder
- Blood donation in the previous 8 weeks
- Positive Covid-19 test within the last month (based on self-report)
Where it is running
- US Army Research Institute of Environmental Medicine — Natick, Massachusetts, United States
Full record on ClinicalTrials.gov
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