Caffeinated Gum for Sleep Deprivation
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using products or drugs that cannot be safely discontinued during the in-laboratory phases, this will be determined on a case-by-case basis by the study physician.
Is caffeinated gum safe for humans?
How is caffeinated gum different from other treatments for sleep deprivation?
Caffeinated gum is unique because it delivers caffeine quickly through chewing, which can help improve alertness and cognitive performance during sleep deprivation. Unlike other treatments, it can rapidly reduce sleep inertia (the grogginess after waking up) and enhance performance in complex tasks, even if it doesn't significantly reduce feelings of sleepiness.12467
What data supports the effectiveness of the treatment caffeinated gum for sleep deprivation?
Are You a Good Fit for This Trial?
This trial is for medical students, residents, and board-certified internists in the National Capital Area who sleep 6-9 hours nightly. Excluded are those with certain health conditions like high blood pressure or obesity, heavy caffeine or alcohol users, smokers, drug users, and people with a history of psychiatric disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sleep Deprivation and Recovery
Participants undergo thirty-seven hours of sleep deprivation followed by ten hours of sleep recovery in a controlled sleep laboratory
FMRI Scan Sessions
Participants undergo two FMRI scan sessions to explore brain activity during therapeutic and diagnostic reasoning
Follow-up
Participants are monitored for safety and effectiveness after the main trial activities
What Are the Treatments Tested in This Trial?
Interventions
- Caffeine
- Military Energy Gum
- Placebo Gum
- Sleep Deprivation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Walter Reed Army Institute of Research (WRAIR)
Lead Sponsor