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RECRUITING
NCT05588934
NA

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

Sponsor: University of Arizona

View on ClinicalTrials.gov

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.

Official title: A Head-to-Head Comparison of the 2B-Alert Caffeine Optimization Algorithm Versus Standard Caffeine Dosing on Performance During Sleep Deprivation (2B-2)

Key Details

Gender

All

Age Range

18 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2023-06-09

Completion Date

2026-03

Last Updated

2025-11-04

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Caffeine Gum

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

OTHER

Placebo Gum

Commercially available non-caffeinated gum.

Locations (2)

University of Arizona

Tucson, Arizona, United States

University of Arizona Psychiatry Department

Tucson, Arizona, United States