Actively Recruiting
Caffeine Optimization Versus Standard Caffeine Dosage (2B-2)
Led by University of Arizona · Updated on 2025-11-04
180
Participants Needed
2
Research Sites
142 weeks
Total Duration
On this page
Sponsors
U
University of Arizona
Lead Sponsor
U
U.S. Army Medical Research Acquisition Activity
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Caffeine Optimization Versus Standard Caffeine Dosage (2B-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-39 years of age
- Adequate understanding of the protocol demonstrated by scoring at least 80% on a short quiz
You will not qualify if you...
- Habitual sleep less than 6 hours or more than 9 hours per night on average
- Bedtimes earlier than approximately 9:00 PM on weeknights
- Wake-up times later than approximately 9:00 AM on weekdays
- Habitual napping more than 3 times per week
- Symptoms or history of sleep disorders including sleep apnea, narcolepsy, hypersomnia, restless leg syndrome, parasomnias, REM behavior disorder
- Use of sleep aids in the 6 months before screening
- History of neurologic disorders such as seizure disorder, amnesia, hydrocephalus, multiple sclerosis
- Regular caffeine use over 400 mg per day
- Beck Depression Inventory score 14 or higher
- Spielberger Trait Anxiety Inventory score 41 or higher
- Morningness-Eveningness Questionnaire score below 31 or above 69
- Regular nicotine use (more than 1 cigarette or equivalent per week) in the last year or positive nicotine test
- Heavy alcohol use (14 or more drinks per week) or positive alcohol test
- History of cardiovascular disease including arrhythmias, valvular heart disease, heart failure, sudden cardiac death, or heart attack
- Acute or chronic lung disease requiring daily inhaler use
- Kidney disease or abnormalities
- Liver disease or abnormalities
- Psychiatric disorder requiring hospitalization or psychiatric medication use
- Use of drugs or products that cannot be safely stopped during the study
- Current illicit drug use or positive drug test
- Positive pregnancy test (females only)
- Breastfeeding or collecting breast milk (females only)
- Resting blood pressure above 140/90 or pulse above 110 beats per minute (exceptions with repeat measurement)
- Body mass index of 30 or higher
- Clinically significant abnormal blood test results
- Unable to read and sign consent
- Military personnel without approved leave
- Failure to complete at least 80% of vigilance tests during the at-home phase
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Arizona
Tucson, Arizona, United States, 85719
Actively Recruiting
2
University of Arizona Psychiatry Department
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
W
William D Killgore, Ph.D.
CONTACT
L
Lindsey Hildebrand, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
OTHER
Number of Arms
5
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