Recruiting

Caffeine Optimization vs. Standard

Sponsor:

University of Arizona

Code:

NCT05588934

Conditions

Sleep Deprivation

Caffeine

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Interventions

Caffeine Gum

Placebo Gum

Study Details

Brief summary:

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.

Conditions

Sleep Deprivation

Caffeine

Study ID

NCT05588934

Start date

Jun 9, 2023

Status verified date

Oct, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Caffeine Gum

Commercially available caffeinated gum that contains 100mg of caffeine per piece of gum.

Placebo Gum

Commercially available non-caffeinated gum.

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 and Locations

Central contacts

William D Killgore, Ph.D.

(520) 621-0605killgore@psychiatry.arizona.edu

Lindsey Hildebrand, MA

(520) 626-2203hildebrandll@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85719

Contacts

William DS Killgore

520-621-0605killgore@psychiatry.arizona.edu

Camryn Wellman

camrynwellman@arizona.edu

University of Arizona Psychiatry Department

Recruiting

Tucson, Arizona, United States, 85724

Contacts

William D Killgore, PhD

520-621-0605killgore@psychiatry.arizona.edu

Principal Investigator:

William Killgore, Ph.D.

More Information

Sponsor

University of Arizona

Last update posted

Nov 4, 2025

Last verified

Oct, 2025

Keywords

  • SLEEP
  • CAFFEINE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-11-04.