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

NCT05588934 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-11-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • U.S. Army Medical Research Acquisition Activity

    collaborator FED

  • Biotechnology High Performance Computing Software Applications Institute

    collaborator UNKNOWN

  • University of Arizona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-09
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588934 on ClinicalTrials.gov