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Optimized Caffeine for Sleep Deprivation (2B-2 Trial)

N/A

Recruiting

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-39 years of age

Be between 18 and 65 years old

Must not have

Kidney disease or kidney abnormalities

Self-reported or suspected current breast-feeding or collecting breast milk (Females only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up peak alertness window: during each overnight sleep deprivation period from 3:00am to 9:00am

Summary

This trial will compare personalized recommended caffeine dosing regimen to the standard recommended regimen to see which one is better for sustaining performance during sleep deprivation and reducing side effects. The study will look at whether personalized caffeine

Who is the study for?

This trial is for individuals aged 18-39 who understand the study protocol, as shown by scoring at least 80% on a quiz. It's designed for those experiencing sleep deprivation and will test if personalized caffeine dosing can improve alertness, mood, cognition during wakefulness, and enhance recovery sleep.

What is being tested?

Participants will compare two caffeine dosing regimens: one tailored to their personal needs (using caffeine gum) versus a standard dose (placebo gum). They'll track sleep with an actigraph watch at home and undergo tests in-lab after staying awake for over two days.

What are the potential side effects?

Potential side effects may include jitteriness, increased heart rate, digestive discomfort or upset stomach from the caffeine gum. Sleep patterns could also be affected leading to difficulty falling asleep post-trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 39 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have kidney disease or abnormalities.

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I am currently breastfeeding or pumping breast milk.

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I have liver disease or abnormalities.

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My BMI is 30 or higher, classifying me as obese.

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I have a history of a sleep disorder.

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I have a history of a neurological disorder.

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I have a history of heart disease.

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I use an inhaler daily for my lung condition.

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I have been hospitalized or taken medication for a psychiatric condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ peak alertness window: during each overnight sleep deprivation period from 3:00am to 9:00am

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~peak alertness window: during each overnight sleep deprivation period from 3:00am to 9:00am

This trial's timeline: 3 weeks for screening, Varies for treatment, and peak alertness window: during each overnight sleep deprivation period from 3:00am to 9:00am for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean psychomotor vigilance test reaction time

Trial Design

5Treatment groups

Active Control

Placebo Group

Group I: Standard Caffeine Dose Both NightsActive Control2 Interventions

Participants will be administer the standard caffeine recommendation (200mg/2 hr. up to 800mg/24 hr.) using caffeinated and non-caffeinated gum during both nights of Phase 2.

Group II: Optimized Caffeine Dose Both NightsActive Control2 Interventions

Participants will be administer the optimized caffeine recommendation (0-300mg/2 hr. up to 800mg/24 hr.) potentially using caffeinated and non-caffeinated gum, depending on optimized dosage, during both nights of Phase 2.

Group III: Placebo Dose 1st Night/Standard Caffeine Dose 2nd NightActive Control2 Interventions

Participants will be administer non-caffeinated, placebo gum during the first night of Phase 2. Then, participants will be administer the standard caffeine recommendation (200mg/2 hr. up to 800mg/24 hr.) using caffeinated and non-caffeinated gum during the second night of Phase 2.

Group IV: Placebo Dose 1st Night/Optimized Caffeine Dose 2nd NightActive Control2 Interventions

Participants will be administer non-caffeinated, placebo gum during the first night of Phase 2. Then, participants will be administer the optimized caffeine recommendation (0-300mg/2 hr. up to 800mg/24 hr.) potentially using caffeinated and non-caffeinated gum, depending on optimized dosage, during the second night of Phase 2.

Group V: Placebo Dose Both NightsPlacebo Group1 Intervention

Participants will be administer non-caffeinated, placebo gum during both nights of Phase 2.

0 / 10Eligibility criteria met