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Caffeine Optimization for Sleep Deprivation

This study is comparing two ways of using caffeine to help people stay alert and focused when they haven't had enough sleep. One way uses a personalized caffeine plan from an app called 2B-Alert, and the other uses standard caffeine recommendations. Researchers want to see if the personalized plan (using Caffeine Gum) is better at improving your alertness, reducing sleepiness, and helping your brain work better after not sleeping. They also want to know if it helps with the physical and emotional side effects of sleep deprivation and leads to better recovery sleep. You might be able to join if you are between 18 and 39 years old and usually sleep 6-9 hours a night. The study is currently recruiting 180 participants.

Study design
This is an interventional study comparing personalized caffeine dosing to standard dosing, involving 180 participants.
What's involved
You will have an enrollment visit, complete personality and mood tests, and wear an actigraph watch and use a phone app for 13 days of at-home testing and sleep data collection.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05588934

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

Recruiting
NAAges 18–39Interventional
University of Arizona
~180 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:Caffeine GumPlacebo Gum

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean psychomotor vigilance test reaction time
Measured over Peak Alertness Window: During each overnight sleep deprivation period from 3:00am to 9:00am

Conditions

Sleep Deprivation
Caffeine

Explore related trials

Sleep deprivation

Where it's being run

2 sites across 1 states
Arizona2

Who to contact

William D Killgore, Ph.D.
[email protected]
(520) 621-0605
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)
Self-reported symptoms suggestive of a sleep disorder (to include but not limited to sleep disordered breathing/sleep apnea, narcolepsy, idiopathic hypersomnia, restless leg syndrome, parasomnias, rapid eye movement (REM) behavior disorder, etc.)
History of a sleep disorder (to include all of the above)
Any use of prescription or over-the-counter sleep aids during the 6-month period prior to screening indicative of a potential sleep disorder as determined by the examining study physician
History of neurologic disorder (e.g., seizure disorder, amnesia for any reason, hydrocephalus, multiple sclerosis)
Self-reported caffeine use \> 400 mg per day on average
Score of 14 or above on the Beck Depression Inventory (BDI)
Score of 41 or above on the Spielberger Trait Anxiety Inventory (STAI-T)
Score below 31 or above 69 on the Morningness-Eveningness Questionnaire
Self-reported regular nicotine use (\> 1 cigarette or equivalent per week) within the last 1 year) or positive nicotine/cotinine result during screening visit
Self-reported heavy alcohol use (≥14 drinks per week or as determined by the examining study physician) or positive saliva alcohol result during screening visit
History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction)
Underlying acute or chronic pulmonary disease requiring daily inhaler use
Kidney disease or kidney abnormalities
Liver disease or liver abnormalities
Self-reported history of psychiatric disorder requiring hospitalization or use of psychiatric medication for any length of time
Self-reported use of products or drugs that cannot be safely discontinued during in-laboratory phases (determined on a case-by-case basis by the examining study physician)
Self-reported current use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana) or positive urine drug screen
(Females only) positive urine pregnancy result
(Females only) self-reported or suspected current breast-feeding or collecting breast milk
Resting blood pressure above 140/90 or resting pulse \> 110 beats per minute (if a physician performs a repeat measurement, \~20 minutes after original measure, and it is within range, volunteer will not be excluded)
BMI ≥ 30 (Obese Class I or greater)
Clinically significant values (as determined by the reviewing study physician) for any hematology or chemistry parameter
Inability to read and sign consent
(Military only) failure to obtain required approved official leave to participate
Failure to cooperate with requirements of the study, e.g. failure to complete 80% of Smart-Psychomotor Vigilance Tests (PVTs) during Phase 1 (Days 2-13)

What this trial measures

  • Mean psychomotor vigilance test reaction timePeak Alertness Window: During each overnight sleep deprivation period from 3:00am to 9:00am

    The mean response time to psychomotor vigilance tests during the Peak Alertness Window.