Status:
COMPLETED
Real-Time Caffeine Optimization During Total Sleep Deprivation
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Caffeine
Sleep Deprivation
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
Sleep deprivation (SD) has a powerful degrading effect on cognitive performance, particularly psychomotor vigilance (PV) and reaction time. Caffeine is well known to be an effective countermeasure to ...
Detailed Description
The first objective of the present study is to determine whether the 2B-Alert Caffeine Optimization Model (2BAlert) can create individualized caffeine schedules that effectively recover PVT performanc...
Eligibility Criteria
Inclusion
- Healthy men and non-pregnant, non-lactating women.
- Must demonstrate adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given one opportunity to retest after a review of protocol information. Individuals who fail the comprehension assessment for the second time will be disqualified
Exclusion
- 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 lights-out times 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) in conjunction with normal sleep habits
- 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, 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 (e.g., use of a sleep aid for several nights following time zone travel, or the occasional use of a sleep inducing medication (e.g. 1-2 times per month), would not necessarily constitute evidence of a sleep disorder and result in disqualification)
- Self-reported caffeine use in excess of 400 mg (e.g., approximately 8 caffeinated sodas or approximately 3-4 12-oz cups of coffee) per day on average
- History of neurologic disorder (to include but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS). An infrequent or resolved single neurological event (e.g., childhood seizure, rare sporadic migraine headaches, resolved meningeal infection with no sequelae) may be deemed non-exclusionary at the discretion of the examining study physician.
- Score of 14 or above on the Beck Depression Inventory
- Score of 41 or above on the Spielberger Trait Anxiety Inventory
- Score of lower than 31 or higher than 69 on the Morningness-Eveningness Questionnaire
- Self-reported or suspected regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week) within the last 1 year)
- Self-reported or suspected heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week or as determined by the examining study physician)
- 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 product for any length of time
- Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases, to be determined on a case-by-case basis by the examining study physician
- Self-reported or suspected current use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana)
- (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 Note that if a repeat measurement 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. Reviewing study physician may opt to repeat any clinically significant tests and include participants whose repeat test values are not clinically significant.
- Positive urine nicotine/cotinine result during screening visit
- Positive urine drug result during screening visit
- Positive saliva alcohol results during screening visit
- Inability to read and sign consent
- 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-PVTs during Phase 1 (Days 2-13)
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04399083
Start Date
February 19 2021
End Date
July 31 2021
Last Update
September 17 2021
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85724