Multiple caffeine doses maintain vigilance during early morning operations.
Gary H Kamimori, Dagny Johnson, David Thorne...
https://pubmed.ncbi.nlm.nih.gov/16313140Actively Recruiting
Phase Not Applicable
Age: 18Years - 39Years
All Genders
Healthy Volunteers
ID05588934
Comparison of 2B-Alert Caffeine Optimization Algorithm Versus Standard Caffeine Dosing on Performance During Sleep Deprivation
Led by University of Arizona · Updated on 2025-11-04
180
Participants Needed
2
Research Sites
N/A
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 research aims to compare a personalized caffeine dosing plan using the 2B-Alert Caffeine Optimization algorithm with the standard caffeine dosing recommendations during periods of total sleep deprivation. The study evaluates whether the personalized approach improves alertness, reduces sleepiness and cognitive decline, manages physical and emotional side effects better, and supports improved recovery sleep following sleep deprivation. Participants will first complete a 13-day at-home phase wearing an actigraph watch to track sleep and activity, and perform motor vigilance tests multiple times daily. Next, they will enter a 4-day in-lab phase including one night of baseline sleep, 62 hours of continuous sleep deprivation, and one night of recovery sleep. During sleep deprivation, participants will receive either caffeine gum or placebo gum under one of five randomized dosing conditions, ranging from placebo to standard and optimized caffeine doses administered on one or both nights. Throughout the study, participants will undergo regular psychomotor vigilance testing, sleep data collection through polysomnography during lab sleep nights, and mood and personality assessments. Researchers will measure reaction times during peak alertness windows, side effect profiles, cognitive function, and quality of recovery sleep. After completing the recovery sleep and all tests, participants will be released from the study, which spans approximately 17 days in total.
CONDITIONS
Brief Title
Caffeine Optimization Versus Standard Caffeine Dosage (2B-2)
Who Can Participate
Age: 18Years - 39Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18-39 years
- Must score at least 80% on a protocol comprehension quiz
You will not qualify if you...
- Habitual sleep less than 6 hours or more than 9 hours per night
- Bedtime earlier than approximately 9:00 PM on weeknights
- Wake-up time later than approximately 9:00 AM on weekdays
- Napping more than 3 times per week
- Symptoms or history of sleep disorders
- Use of sleep aids in the past 6 months
- History of neurologic disorders
- Regular caffeine use over 400 mg per day
- Beck Depression Inventory score of 14 or higher
- Spielberger Trait Anxiety Inventory score of 41 or higher
- Morningness-Eveningness Questionnaire score below 31 or above 69
- Regular nicotine use or positive nicotine test
- Heavy alcohol use or positive alcohol test
- History of cardiovascular disease
- Acute or chronic pulmonary disease requiring daily inhaler
- Kidney or liver disease
- History of psychiatric hospitalization or medication
- Use of drugs that cannot be safely discontinued in lab
- Current illicit drug use or positive drug test
- For females: positive pregnancy test or breastfeeding
- Resting blood pressure above 140/90 or pulse over 110 bpm
- BMI 30 or higher
- Clinically significant abnormal lab values
- Inability to read and sign consent
- Military participants without approved leave
- Failure to complete 80% of required vigilance tests during Phase 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
At-home Data Collection
Duration - 13 days
Participants complete baseline personality and mood testing, then wear an actigraph watch and use the 2B-Alert app to collect sleep and psychomotor vigilance data at home.
1 enrollment visit and daily data collection at home
In-lab Sleep and Sleep Deprivation
Duration - 4 days
Participants spend 4 days in the lab including a night of baseline sleep monitored by polysomnography followed by 62 hours of continuous sleep deprivation during which psychomotor vigilance tests are performed periodically. During this period, participants receive caffeine or placebo gum according to their assigned condition.
Continuous in-lab stay with multiple assessments and caffeine/placebo administration
Recovery Sleep and Final Testing
Duration - 1 day
Participants complete a night of recovery sleep monitored by polysomnography followed by additional psychomotor vigilance testing before being released from the lab.
1 in-lab recovery sleep night and follow-up testing visit
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
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Research Team
W
William D Killgore, Ph.D.
L
Lindsey Hildebrand, MA
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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Published Research Related To This Trial
Sustaining executive functions during sleep deprivation: A comparison of caffeine, dextroamphetamine, and modafinil.
William D S Killgore, Ellen T Kahn-Greene, Nancy L Grugle...
https://pubmed.ncbi.nlm.nih.gov/19238808Multiple caffeine doses maintain vigilance, attention, complex motor sequence expression, and manual dexterity during 77 hours of total sleep deprivation.
William D S Killgore, Gary H Kamimori
https://pubmed.ncbi.nlm.nih.gov/33364521Real-time individualization of the unified model of performance.
Jianbo Liu, Sridhar Ramakrishnan, Srinivas Laxminarayan...
https://pubmed.ncbi.nlm.nih.gov/28436072A Unified Model of Performance: Validation of its Predictions across Different Sleep/Wake Schedules.
Sridhar Ramakrishnan, Nancy J Wesensten, Thomas J Balkin...
https://pubmed.ncbi.nlm.nih.gov/26518594A Unified Model of Performance for Predicting the Effects of Sleep and Caffeine.
Sridhar Ramakrishnan, Nancy J Wesensten, Gary H Kamimori...
https://pubmed.ncbi.nlm.nih.gov/273975622B-Alert Web: An Open-Access Tool for Predicting the Effects of Sleep/Wake Schedules and Caffeine Consumption on Neurobehavioral Performance.
Jaques Reifman, Kamal Kumar, Nancy J Wesensten...
https://pubmed.ncbi.nlm.nih.gov/27634801Caffeine dosing strategies to optimize alertness during sleep loss.
Francisco G Vital-Lopez, Sridhar Ramakrishnan, Tracy J Doty...
https://pubmed.ncbi.nlm.nih.gov/29808510