Caffeine Optimization Versus Standard Caffeine Dosage (2B-2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-39 years of age
Must demonstrate adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz
Disqualifiers
Self-reported habitual nightly sleep amounts outside the target range of approximately 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average)
Self-reported nighttime bedtimes earlier than approximately 2100 hours on average during weeknights (Sunday through Thursday)
Self-reported morning wake-up times later than approximately 0900 on average during weekdays (Monday through Friday)
Self-reported habitual napping (> 3 times per week)
Trial design
Design model
Factorial
Treatments tested in this trial
Caffeine Gum
Dietary supplementCommercially available caffeinated gum that contains 100mg of caffeine per piece of gum.
Placebo Gum
Other interventionCommercially available non-caffeinated gum.
Treatment groups
180 Participants
are divided into 5 treatment groupsGroup A: Placebo Dose Both NightsPlacebo comparator 1 intervention
Group B: Standard Caffeine Dose Both NightsActive comparator 2 interventions
Group C: Optimized Caffeine Dose Both NightsActive comparator 2 interventions
Group D: Placebo Dose 1st Night/Standard Caffeine Dose 2nd NightActive comparator 2 interventions
Group E: Placebo Dose 1st Night/Optimized Caffeine Dose 2nd NightActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Mean psychomotor vigilance test reaction time
The mean response time to psychomotor vigilance tests during the Peak Alertness Window.
Time frame
Peak Alertness Window: During each overnight sleep deprivation period from 3:00am to 9:00amSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
U.S. Army Medical Research Acquisition Activity
Collaborator
Biotechnology High Performance Computing Software Applications Institute
Collaborator
Source ClinicalTrials.gov