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

Launched by UNIVERSITY OF ARIZONA · Oct 17, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Caffeine Optimization Versus Standard Caffeine Dosage," is looking to find out if personalized caffeine recommendations can help people perform better when they haven't slept well. The study will compare these tailored caffeine doses to the usual standard recommendations to see which one helps improve alertness, reduce tiredness, and support better thinking after a period of sleep deprivation. It will also explore how each approach affects emotional and physical side effects from lack of sleep and whether it helps with recovery sleep afterward.

To participate, individuals should be between 18-39 years old and generally sleep around 6-9 hours a night. They will first wear a watch that tracks their activity and sleep for 13 days and complete tests to measure their attention. Then, they will spend 4 days in a lab to undergo one night of regular sleep, followed by 62 hours without sleep, and finish with a recovery sleep night. It’s important to note that some people may not be eligible if they have certain sleep disorders, take specific medications, or have a history of significant health issues. Overall, this study aims to help improve how caffeine can be used to support those who experience sleep deprivation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-39 years of age
• • Must demonstrate adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz
• Exclusion Criteria:
• • Self-reported habitual nightly sleep amounts outside the target range of approximately 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average)
• • Self-reported nighttime bedtimes earlier than approximately 2100 hours on average during weeknights (Sunday through Thursday)
• • Self-reported morning wake-up times later than approximately 0900 on average during weekdays (Monday through Friday)
• • Self-reported habitual napping (\> 3 times per week)
• • Self-reported symptoms suggestive of a sleep disorder (to include but not limited to sleep disordered breathing/sleep apnea, narcolepsy, idiopathic hypersomnia, restless leg syndrome, parasomnias, rapid eye movement (REM) behavior disorder, etc.)
• • History of a sleep disorder (to include all of the above)
• • Any use of prescription or over-the-counter sleep aids during the 6-month period prior to screening indicative of a potential sleep disorder as determined by the examining study physician
• • History of neurologic disorder (e.g., seizure disorder, amnesia for any reason, hydrocephalus, multiple sclerosis)
• • Self-reported caffeine use \> 400 mg per day on average
• • Score of 14 or above on the Beck Depression Inventory (BDI)
• • Score of 41 or above on the Spielberger Trait Anxiety Inventory (STAI-T)
• • Score below 31 or above 69 on the Morningness-Eveningness Questionnaire
• • Self-reported regular nicotine use (\> 1 cigarette or equivalent per week) within the last 1 year) or positive nicotine/cotinine result during screening visit
• • Self-reported heavy alcohol use (≥14 drinks per week or as determined by the examining study physician) or positive saliva alcohol result during screening visit
• • History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction)
• • Underlying acute or chronic pulmonary disease requiring daily inhaler use
• • Kidney disease or kidney abnormalities
• • Liver disease or liver abnormalities
• • Self-reported history of psychiatric disorder requiring hospitalization or use of psychiatric medication for any length of time
• • Self-reported use of products or drugs that cannot be safely discontinued during in-laboratory phases (determined on a case-by-case basis by the examining study physician)
• • Self-reported current use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana) or positive urine drug screen
• • (Females only) positive urine pregnancy result
• • (Females only) self-reported or suspected current breast-feeding or collecting breast milk
• • Resting blood pressure above 140/90 or resting pulse \> 110 beats per minute (if a physician performs a repeat measurement, \~20 minutes after original measure, and it is within range, volunteer will not be excluded)
• • BMI ≥ 30 (Obese Class I or greater)
• • Clinically significant values (as determined by the reviewing study physician) for any hematology or chemistry parameter
• • Inability to read and sign consent
• • (Military only) failure to obtain required approved official leave to participate
• • Failure to cooperate with requirements of the study, e.g. failure to complete 80% of Smart-Psychomotor Vigilance Tests (PVTs) during Phase 1 (Days 2-13)