Real-Time Caffeine Optimization During Total Sleep Deprivation

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 19, 2021

Primary Completion Date

July 31, 2021

Study Completion Date

July 31, 2021

Conditions
CaffeineSleep DeprivationShift-Work Related Sleep Disturbance
Interventions
DIETARY_SUPPLEMENT

Caffeine

"Caffeine will be administered to each participant following an individualized optimal dosing schedule created by the 2B-Alert app. Individualized caffeine dosing schedules will be created by the 2BAlert app on the smartphone the participant uses to do Smart-PVT tests. Study staff will run the optimization at 1900 on Day 15. The algorithm will recommend caffeine dosing to optimize performance during the Peak Alertness window (e.g. from 0300-0900 on Day 16, 44-50 hours of continuous sleep loss). Doses could be recommended at any hour from 2000 on Day 15 to 0800 on Day 16. HOWEVER, the algorithm will not exceed 800 mg of caffeine across the entire study AND it will not dose more than 300 mg of caffeine at a time. Gum will be chewed for a total of 10 minutes by each participant and then discarded.~As there will be no placebo in this protocol, randomization and blinding procedures are not necessary. IT IS IMPORTANT TO NOTE THAT SOME PARTICIPANTS MAY NOT RECEIVE CAFFEINE AT ALL."

Trial Locations (1)

85724

University of Arizona, Tucson

All Listed Sponsors
collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

lead

University of Arizona

OTHER

NCT04399083 - Real-Time Caffeine Optimization During Total Sleep Deprivation | Biotech Hunter | Biotech Hunter