An interventional study of Military Energy Gum and Placebo Gum in Sleep Deprivation and Performance, sponsored by Walter Reed Army Institute of Research (WRAIR). Terminated at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Walter Reed Army Institute of Research (WRAIR) · Not applicable, Interventional, and Basic science
While the negative impact of sleep deprivation on cognitive processing and the partial reversal of this phenomenon by caffeine are well known, the types of cognitive processing previously studied have been limited to simple, straight-forward laboratory tasks. It is unclear how sleep deprivation and caffeine affect performance on operationally relevant complex cognitive tasks, like those encountered by working professionals such as doctors. This study aims to uncover how sleep deprivation and caffeine impact two types of clinical reasoning processes encountered by physicians on a daily basis. Previous work from members of our team investigated diagnostic reasoning in medical professionals and discovered that brain activation in executive processing areas was modulated by self-reported sleepiness and burnout and level of expertise (Durning, Costanzo, et al., 2013; Durning et al., 2014, 2015). The current study aims to expand upon those findings by also investigating a potentially more complex type of clinical reasoning, i.e. therapeutic reasoning, and directly manipulating sleep and caffeine use in a controlled sleep laboratory. Medical students, residents, and board-certified physicians will undergo thirty-seven hours of sleep deprivation and ten hours of sleep recovery in the sleep laboratory. During two FMRI scan sessions we will present high-quality validated multiple-choice questions on common patient situations in internal medicine to participants to explore brain activity during therapeutic reasoning compared with diagnostic reasoning. One FMRI scan will occur following a night of sleep deprivation, and another scan will occur following a night of recovery sleep. Additionally, half of the participants will receive caffeine gum during the sleep deprivation period, while the other half will receive placebo gum. This design will allow us to study the effect of sleep deprivation and caffeine on the neural correlates of diagnostic and therapeutic reasoning and performance in general.
Exclusion Criteria:
Related to Sleep Research Center. The following exclusion criteria apply to all volunteers:
Related to FMRI task.
The following exclusion criteria apply to all subjects (MR Safety Screening form):
This group will receive caffeine gum.
Dietary Supplement: Military Energy Gum
This group will receive gum without caffeine.
Dietary Supplement: Placebo Gum
Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant that is found naturally in some foods and beverages such as coffee and tea. For this study, caffeine will be administered in the form of gum pellets (Military Energy chewing gum). Each pellet contains 100 mg of caffeine.
Pellet form placebo gum
Psychomotor Vigilance Task
Computer Based response time measurement
Time frame: 5 days
Clinical Reasoning Questions
Answer clinical board questions
Time frame: 5 days
Actigraphy
Wrist movement and activity monitoring
Time frame: 5 days
Polysomnography
Measurement of brain activity
Time frame: 5 days
Structural Brain Scan-functional MRI
Measurement of structural brain topography to localize areas of functional activation using a functional MRI scan
Time frame: 5 days
Plan to share: No
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Walter Reed Army Institute of Research (WRAIR)