Caffeine Optimization Versus Standard Caffeine Dosage (2B-2)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT05588934
Status
Recruiting
Apply to this trial

Conditions

  • Caffeine
  • Sleep Deprivation

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • Caffeine Gum — DIETARY_SUPPLEMENT
    Commercially available caffeinated gum that contains 100mg of caffeine per piece of gum.
  • Placebo Gum — OTHER
    Commercially available non-caffeinated gum.

Study Details

This clinical trial will be a comparison between personalized recommended caffeine dosing regimen versus the standard recommended caffeine dosing regimen for sustaining performance during sleep deprivation and minimizing side effects and subsequent sleep disruption. The questions this study aims to answer are: Whether the personalized caffeine recommendations improve vigilance, sleepiness, and cognition after total sleep deprivation, compared to standard recommendations; Whether the personalized caffeine recommendation better addresses the physical and emotional side effects of total sleep deprivation, compared to standard recommendations; And whether personalized caffeine recommendations aids in better recovery sleep after total sleep deprivation, compared to standard recommendations. Participants will be asked to: 1. Complete a 13-day at-home portion, wearing an actigraph watch to measure activity and sleep, and complete motor vigilance tests up to six times a day. 2. Complete a 4-day in-lab portion, where participants will have to complete one night of baseline sleep, undergo 62-hours of total sleep deprivation, and then complete one night of recovery sleep. 3. During the in-lab portion of the study, participants will be asked to complete more motor vigilance tests. Researchers will be comparing the personalized caffeine recommendation group against the standard caffeine recommendation to see if it is better at addressing each of the main questions.

Key Dates

Start date
Jun 9, 2023
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo Dose Both Nights
    Participants will be administer non-caffeinated, placebo gum during both nights of Phase 2.
  • Active Comparator: Standard Caffeine Dose Both Nights
    Participants will be administer the standard caffeine recommendation (200mg/2 hr. up to 800mg/24 hr.) using caffeinated and non-caffeinated gum during both nights of Phase 2.
  • Active Comparator: Optimized Caffeine Dose Both Nights
    Participants will be administer the optimized caffeine recommendation (0-300mg/2 hr. up to 800mg/24 hr.) potentially using caffeinated and non-caffeinated gum, depending on optimized dosage, during both nights of Phase 2.
  • Active Comparator: Placebo Dose 1st Night/Standard Caffeine Dose 2nd Night
    Participants will be administer non-caffeinated, placebo gum during the first night of Phase 2. Then, participants will be administer the standard caffeine recommendation (200mg/2 hr. up to 800mg/24 hr.) using caffeinated and non-caffeinated gum during the second night of Phase 2.
  • Active Comparator: Placebo Dose 1st Night/Optimized Caffeine Dose 2nd Night
    Participants will be administer non-caffeinated, placebo gum during the first night of Phase 2. Then, participants will be administer the optimized caffeine recommendation (0-300mg/2 hr. up to 800mg/24 hr.) potentially using caffeinated and non-caffeinated gum, depending on optimized dosage, during the second night of Phase 2.

Primary Outcome Measure

Mean psychomotor vigilance test reaction time [ Time Frame: Peak Alertness Window: During each overnight sleep deprivation period from 3:00am to 9:00am ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85719
William DS Killgore
[email protected]
520-621-0605
Camryn Wellman
[email protected]
University of Arizona Psychiatry DepartmentTucsonArizona85724
William D Killgore, PhD
[email protected]
520-621-0605
William Killgore, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Arizona· Tucson, AZUniversity of Arizona Psychiatry Department· Tucson, AZ

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