7 Participants Needed

Caffeinated Gum for Sleep Deprivation

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Walter Reed Army Institute of Research (WRAIR)

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?

Caffeinated gum, like other forms of caffeine, is generally safe for humans when used in moderation. Studies show it can improve alertness and mood during sleep deprivation without significant side effects, especially when used acutely and without the opportunity for sleep.12345

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?

Research shows that caffeinated gum can improve cognitive functions and reduce performance errors during sleep deprivation. Caffeine is effective in enhancing alertness, response time, and accuracy, making it a useful countermeasure against the effects of sleep loss.12689

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

Novice group - National Capital Area Interns and Medical Students (3rd and 4th year only)
Expert group - Board certified internists from National Capital Area
Intermediate group - National Capital Area PGY-2 and 3 residents in internal medicine

Exclusion Criteria

You have a high level of anxiety, scoring 41 or higher on a specific anxiety test.
I have a history of a neurological disorder.
Active duty military or federal personnel not off duty and not on approved annual leave for the enrollment visit as well as the in-laboratory phase of the study
See 29 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Sleep Deprivation and Recovery

Participants undergo thirty-seven hours of sleep deprivation followed by ten hours of sleep recovery in a controlled sleep laboratory

2 days
In-lab stay

FMRI Scan Sessions

Participants undergo two FMRI scan sessions to explore brain activity during therapeutic and diagnostic reasoning

5 days
2 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main trial activities

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Caffeine
  • Military Energy Gum
  • Placebo Gum
  • Sleep Deprivation
Trial Overview The study tests how sleep deprivation affects complex cognitive tasks in medical professionals by comparing brain activity during diagnostic and therapeutic reasoning after sleep loss versus recovery sleep. Participants will be deprived of sleep for 37 hours followed by recovery rest. Half will chew Military Energy Gum containing caffeine; the other half placebo gum.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Caffeine GroupActive Control1 Intervention
This group will receive caffeine gum.
Group II: PlaceboPlacebo Group1 Intervention
This group will receive gum without caffeine.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Walter Reed Army Institute of Research (WRAIR)

Lead Sponsor

Trials
111
Recruited
108,000+

Published Research Related to This Trial

Sleep deprivation in the intensive care unit (ICU) is a major factor contributing to delirium in adult patients, highlighting the need for effective management strategies to improve patient outcomes.
Implementing a multidisciplinary approach that includes sleep hygiene practices, tailored nursing care, and appropriate medications can help reduce sleep deprivation and, consequently, the incidence of delirium in ICU patients.
Sleep Deprivation in the Intensive Care Patient.Grimm, J.[2022]
A study involving 24 healthy volunteers showed that 300 mg of slow-release caffeine significantly improved vigilance and performance during periods of sleep deprivation, lasting up to 13 hours after intake.
The research indicated that while both 300 mg and 600 mg doses were effective, the 300 mg dose was optimal for maximizing benefits without side effects, and there was no difference in performance during recovery after sleep.
Slow-release caffeine: a new response to the effects of a limited sleep deprivation.Lagarde, D., Batéjat, D., Sicard, B., et al.[2015]

Citations

The effectiveness of caffeinated chewing gum in ameliorating cognitive functions affected by sleep deprivation. [2022]
Caffeine may disrupt the impact of real-time drowsiness on cognitive performance: a double-blind, placebo-controlled small-sample study. [2021]
Effects of acute caffeine consumption following sleep loss on cognitive, physical, occupational and driving performance: A systematic review and meta-analysis. [2020]
Sleep Deprivation in the Intensive Care Patient. [2022]
Caffeine gum minimizes sleep inertia. [2013]
Slow-release caffeine: a new response to the effects of a limited sleep deprivation. [2015]
Caffeine reversal of sleep deprivation effects on alertness and mood. [2019]
Slow-release caffeine as a countermeasure to driver sleepiness induced by partial sleep deprivation. [2019]
Caffeine prevents sleep loss-induced deficits in long-term potentiation and related signaling molecules in the dentate gyrus. [2014]
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