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Completed

NCT Number: NCT06636825

Influence of Caffeine on Psychomotor Vigilance and Carbon Dioxide Tolerance During Graded Hypercapnia

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Graded hypercapnia

Other

Volunteers breathe 0%, 2%, 4%, 6%, and 8% CO2 (with 21% O2, balance nitrogen) for 12 minutes each

Caffeine

Drug

400 mg caffeine capsule taken in a single dose 1 hour prior to graded hypercapnia

Placebo

Drug

Placebo (microcrystalline cellulose) capsule taken in a single dose 1 hour prior to graded hypercapnia

Primary outcomes

  1. End-tidal CO2

    Time frame: 60 minutes

    End-tidal CO2 (mmHg)

  2. PVT Performance

    Time frame: 60 minutes

    Psychomotor vigilance (mean reaction time in s)

  3. Carbon dioxide tolerance

    Time frame: 60 minutes

    Time spent in graded hypercapnia protocol (minutes)

Secondary outcomes

  1. Ventilation

    Time frame: 60 minutes

    Ventilation (L/min)

  2. Respiratory Rate

    Time frame: 60 minutes

    Breaths per minute

  3. Tidal volume

    Time frame: 60 minutes

    Tidal volume (L)

  4. Oxygen Consumption

    Time frame: 60 minutes

    Oxygen consumption (L/min)

  5. Carbon dioxide release

    Time frame: 60 minutes

    Carbon dioxide release (L/min)

  6. Heart Rate

    Time frame: 60 minutes

    Heart Rate (Beats per minute)

  7. Blood Pressure

    Time frame: 60 minutes

    Blood pressure (mmHg)

  8. Total Mood Disturbance

    Time frame: 60 minutes

    Profile of Mood States (AU); higher number is worse mood

  9. Arterialized capillary pH

    Time frame: 60 minutes

    pH (unitless)

  10. Arterialized capillary PCO2

    Time frame: 60 minutes

    Partial pressure of carbon dioxide (mmHg)

  11. Arterialized capillary bicarbonate

    Time frame: 60 minutes

    Bicarbonate (mmol/L))

  12. Dyspnea

    Time frame: 60 minutes

    Borg 0-10 Scale (higher number is more dyspnea)

  13. Discomfort

    Time frame: 60 minutes

    Borg 0-10 Scale (higher number is more discomfort)

  14. Headache

    Time frame: 60 minutes

    100mm visual analog scale (higher number is worse headache)

  15. Plasma caffeine

    Time frame: 60 minutes

    Plasma caffeine (ug/mL)

  16. Plasma theobromine

    Time frame: 60 minutes

    Plasma theobromine (ug/mL)

  17. Plasma theophylline

    Time frame: 60 minutes

    Plasma theophylline (ug/mL)

  18. Plasma paraxanthine

    Time frame: 60 minutes

    Plasma paraxanthine (ug/mL)

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Acronym: C3F

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

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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