An interventional study of Caffeine Gum and Placebo Gum in Sleep Deprivation and Caffeine, sponsored by University of Arizona. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-04.
Sponsored by University of Arizona · Not applicable, Interventional, and Other
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:
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.
This clinical trial will be examining whether the 2B-Alert Caffeine Optimization algorithm provides greater performance optimization, side effect minimization, and quality of recovery sleep during sleep deprivation compared to the standard published recommendations for caffeine use. The objective of this clinical trial will be to conduct a head-to-head comparison between the 2B-Alert app versus a commonly recommended caffeine dosing regimen for sustaining optimal performance during sleep deprivation and minimizing side effects and subsequent sleep disruption. The specific aims are to: Determine the effectiveness of 2B-Alert versus standard caffeine dosing on psychomotor vigilance, subjective sleepiness, and cognition on single and multiple nights of sleep deprivation; Determine the effectiveness of 2B-Alert versus standard caffeine dosing at mitigating physiological and emotional side effects; Determine the effectiveness of 2B-Alert versus standard caffeine dosing at minimizing disruptions in recovery sleep.
This clinical trial will consist of three phases. Phase 1 includes the enrollment visit where participants will come into the lab, complete baseline personality and mood testing, and be given the actigraph watch and phone with the 2B-Alert app. Then the participant will undergo 13-days of at-home psychomotor vigilance testing and sleep data collection.
Phase 2 begins with the participant arrives at the lab for the 4-day in-lab portion of the study. During this phase the participant will complete a night of baseline sleep using polysomnography to collect sleep data. At the end of baseline sleep, the participant will begin the 62-hour sleep deprivation portion. During the deprivation portion, data will be collected periodically on the participants psychomotor vigilance. After 37-49 hours of continuous sleep deprivation participants will be administered either caffeine gum or placebo gum.
There are four different experimental conditions and one control condition that determines the ratio of caffeine gum to placebo gum that is administered to participants:
After the 62-hour period of total sleep deprivation, participants will complete Phase 3, a night of recovery sleep; During this phase, participants' sleep data will be collected using polysomnography. After the night of recovery sleep participants will remain in the lab for further psychomotor vigilance testing. Once this is complete individuals will be released from the lab and their participation will be complete.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's planned enrollment of 180 is above the median of 45 across 248 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be administer non-caffeinated, placebo gum during both nights of Phase 2.
Other: Placebo Gum
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.
Dietary Supplement: Caffeine Gum · Other: Placebo Gum
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.
Dietary Supplement: Caffeine Gum · Other: Placebo Gum
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.
Dietary Supplement: Caffeine Gum · Other: Placebo Gum
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.
Dietary Supplement: Caffeine Gum · Other: Placebo Gum
Commercially available caffeinated gum that contains 100mg of caffeine per piece of gum.
Also known as: Military Energy Gum
Commercially available non-caffeinated gum.
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 9:00am
Plan to share: No — There is no plan to make individual participant data available to other researchers. All data that will be shared from this clinical trial will be shared in summary data sets.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Arizona