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NCT04399083 · ClinicalTrials.gov registry record · NA
Real-Time Caffeine Optimization During Total Sleep Deprivation
A NA study, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT04399083: Completed NA study, sponsored by University of Arizona.
NCT04399083 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04399083, a NA study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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 the effects of SD. However, individuals differ in both their response to SD and to the administration of caffeine. This has made it difficult to provide individualized recommendations regarding the use of caffeine to sustain alertness when needed. For the past two decades, the Army's Biotechnology HPC Institute (BHSAI), in collaboration with the Walter Reed Army Institute of Research, have been developing statistical models to predict individual performance during prolonged SD. Recently, this resulted in the publication of the 2B-Alert app, a computer algorithm based on large datasets that can learn an individual's response to SD by combining actigraphic sleep data with simultaneously acquired PV performance data. The 2B-Alert algorithm can predict an individual's sleep need and performance after \~2 weeks of training the model. Recently, the model has been extended to incorporate individualized responses to caffeine. This was recently validated in a retrospective study published by BHSAI in 2019. The present study is designed to test the predictive capacity of the 2B-Alert app in real time. During Phase 1 a total of 21 healthy participants will wear an actigraph \& complete multiple daily PV tests on a personal cell phone. After 2 weeks, these individuals will attend Phase 2 involving an in-laboratory stay \& SD. Participants will have an 8-hour period of sleep in the laboratory, followed by 62 hours of continuous wakefulness. During these 62 hours, participants will complete PV and mood testing every 3 hours. The 2B-Alert app will be used to predict individual caffeine need to sustain performance at near-baseline levels based on the statistical model. At 44 hours SD, participants will undergo a 6-hour "alertness window" where they may receive individualized doses of c
Primary Outcome
Assesses the effects of sleep loss on visual reaction time as a behavioral measure of sleepiness Subjects continuously monitor a blank display and touch the smart phone screen as quickly as possible in response to a visual stimulus (i.e. a millisecond counter that begins at zero and stops when you press the button). Outcome measures: Mean RT (ms), Mean Speed (s-1), Lapses (#) The primary objective of this study is to determine if the real-time 2B-Alert Caffeine Optimization algorithm can produce
Interventions
- DIETARY_SUPPLEMENT Caffeine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-02-19 |
| Est. Completion | 2021-07-31 |
| Phase | NA |
What the finished NCT04399083 record still lists
NCT04399083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Caffeine is the first listed.
NCT04399083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04399083 about?
NCT04399083 is a clinical study titled "Real-Time Caffeine Optimization During Total Sleep Deprivation". 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 the effects of SD. However, individuals differ in both their response to SD and to the administratio...
What is the current status of trial NCT04399083?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-02-19. Estimated completion is 2021-07-31.
What interventions are being tested in trial NCT04399083?
The interventions under investigation include: Caffeine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04399083?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04399083's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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