What is the 2B-Alert caffeine optimization algorithm studying for sleep deprivation?

Researchers are studying whether the 2B-Alert caffeine optimization algorithm improves alertness, cognition, and recovery sleep during total sleep deprivation compared to standard caffeine recommendations. The trial evaluates if personalized caffeine dosing can reduce side effects and improve performance. This study is sponsored by the University of Arizona and compares different caffeine dosing strategies using gum in a controlled setting.

Who may be eligible for this sleep deprivation clinical trial?

Adults aged 18 to 39 who have typical sleep habits and no major health issues may be eligible. Participants must understand the study protocol and have limited caffeine and nicotine use. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this sleep deprivation clinical trial?

Study-related care, including the study gum and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 39Years

All Genders

Healthy Volunteers

ID05588934

Comparison of Personalized 2B-Alert Caffeine Dosing Versus Standard Dosage for Performance During Sleep Deprivation

Led by University of Arizona · Updated on 2025-11-04

180

Participants Needed

Research Sites

N/A

Total Duration

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)

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Optimized caffeine gum	Placebo gum	Standard caffeine gum	Typical over‑the‑counter caffeine (e.g., coffee)
What it is	Chewing caffeinated gum with optimized dose tailored per condition both nights	Chewing non‑caffeinated placebo gum during two nights of sleep deprivation	Chewing caffeinated gum at a standard fixed dose (100 mg per piece) both nights	Using typical over‑the‑counter caffeine such as coffee or energy drinks for daytime alertness during sleep loss
Role in study	Investigational arm testing tailored dosing strategy	Inactive control to measure placebo effects	Standard fixed‑dose comparator based on current dosing practice	Represents usual real‑world caffeine use outside the trial
Primary use	Evaluate whether adaptive caffeine dosing improves alertness more effectively	Control for comparison without active stimulant effect	Provide a fixed, commonly used caffeine dose during sleep deprivation	Used by many individuals for temporary alertness during sleep deprivation
How it is given or performed	Participants chew gum with doses tailored per sleep deprivation schedule both nights	Participants chew non‑caffeinated gum both nights	Participants chew gum containing standard caffeine dose both nights	Consumed as beverages like coffee or energy drinks according to individual habits
Evidence status	Hypothesized to deliver greater or more efficient alertness benefit via tailored dosing	Used as control; no performance benefit expected	Expected to improve alertness based on known effects of fixed caffeine dosing	Common caffeine use improves alertness but may vary by dose and timing
Important risks	Risk profile similar to standard caffeine but dosing adjusted to reduce excess intake	No caffeine‑related side effects	Potential jitteriness or sleep disruption from caffeine	Possible sleep disturbance or jitteriness depending on dose and timing
Important limitations	Adaptive dosing needs validation for feasibility and effectiveness in real‑world use	Provides no active alertness aid; cannot inform dose–response	Fixed dose may not suit individual sleep‑loss profiles	Real‑world caffeine use lacks precise timing and dose control and may not align with optimal alertness windows

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

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

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