Caffeinated Gum for Sleep Deprivation

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Walter Reed Army Institute of Research (WRAIR)

Must not be taking: Calcium channel blockers, Benzodiazepines

Disqualifiers: Cardiovascular, Neurologic, Pulmonary, Psychiatric, others

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how sleep deprivation and caffeine affect complex thinking tasks that doctors encounter daily. Participants will remain awake for about 37 hours and receive either caffeine gum (Military Energy Gum) or placebo gum to assess its impact on their ability to solve medical problems. Suitable candidates for this trial include medical students, residents, and board-certified internists who do not have sleep issues and do not consume excessive caffeine.

As an unphased study, this trial allows participants to contribute to important research that could enhance medical practice.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that caffeine gum might enhance task performance when individuals are tired. For example, one study found that it can reduce errors made by sleepy drivers. Another study suggested that 300mg of caffeine in gum can improve cognitive skills in fatigued individuals.

However, caffeine can also cause side effects. Some research indicates that it might lead to sleep disturbances or prolonged wakefulness. In high-stress situations, such as military operations, excessive caffeine has been linked to sleep problems.

Overall, caffeine gum appears well-tolerated, but it might disrupt sleep. When considering participation in a trial, individuals should reflect on how caffeine typically affects them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for sleep deprivation involve lifestyle changes, sleep hygiene techniques, or medications like sedatives and stimulants. However, caffeine gum offers a unique approach by providing a quick and convenient delivery method for caffeine, which is the active ingredient. Unlike pills or drinks, this gum allows for rapid absorption of caffeine through the mouth, potentially offering faster relief from the effects of sleep deprivation. Researchers are excited because this could mean a more immediate boost in alertness and cognitive function, making it a practical solution for those needing a quick pick-me-up.

What evidence suggests that caffeine gum is effective for improving cognitive performance during sleep deprivation?

This trial will compare the effects of caffeinated gum with placebo gum. Studies have shown that caffeine can enhance cognitive function in tired individuals. Research indicates that caffeine consumption reduces errors, such as those made by sleepy drivers. One study suggested that 300mg of caffeine can boost cognitive skills in sleep-deprived individuals. Another study found that caffeine can mitigate the negative effects of sleep loss on mental abilities. These findings suggest that caffeinated gum, which participants in this trial may receive, could improve decision-making in fatigued medical professionals. ^{1 2 3 4 5}

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

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?

Group I: Caffeine Group Active Control 1 Intervention

This group will receive caffeine gum.

Group II: Placebo Placebo Group 1 Intervention

This group will receive gum without caffeine.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow-release caffeine: a new response to the effects of a limited sleep deprivation. Lagarde, D., Batéjat, D., Sicard, B., et al.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Deprivation in the Intensive Care Patient. Grimm, J.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8487254/

The effects of caffeinated products on sleep and ... Observational studies showed that caffeine consumption was associated with insomnia symptoms and decreased sleep duration. Moreover, ED use was also associated ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9210557/

The effectiveness of caffeinated chewing gum in ... This study suggests that the dose of 300mg of caffeine could effectively enhance the cognitive functions of Iranian individuals suffering from sleep ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1419181/full

Ad libitum caffeine consumption, cognitive performance ... It demonstrates that caffeine consumption can mitigate some effects of sleep loss on cognitive abilities.

4. militaryenergy.com militaryenergy.com/research

Research A Defence fatigue study has found caffeine gum can reduce driver error in sleep deprived people. Caffeine intake significantly reduces driver errors.

5. tandfonline.com tandfonline.com/doi/full/10.1080/1028415X.2018.1443996

Caffeine and energy drink use by combat arms soldiers in ... Higher caffeine consumption was associated with disrupted sleep from high operational tempo and nighttime duties of combat operations.