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Caffeinated Gum for Sleep Deprivation
N/A
Waitlist Available
Research Sponsored by Walter Reed Army Institute of Research (WRAIR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
History of neurologic disorder
Kidney disease or kidney abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Summary
This trial is investigating how sleep deprivation and caffeine consumption affects the cognitive processes of medical professionals while they are working.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from Military Energy Gum may include jitteriness, increased heart rate, digestive discomforts such as stomachache or nausea, insomnia if taken late in the day (due to caffeine), and potential headache upon withdrawal.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of a neurological disorder.
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I have kidney disease or abnormalities.
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I use medications that can't be stopped for a study.
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I use an inhaler daily for my lung condition.
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My BMI is 30 or higher, indicating obesity.
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I have liver disease or abnormalities.
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I am currently taking calcium channel blocker medications.
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I have a history of heart disease.
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I am currently breastfeeding, lactating, or trying to get pregnant.
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I have been hospitalized or taken medication for a psychiatric condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Reasoning Questions
Psychomotor Vigilance Task
Secondary study objectives
Actigraphy
Polysomnography
Structural Brain Scan-functional MRI
Trial Design
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.
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Who is running the clinical trial?
Walter Reed Army Institute of Research (WRAIR)Lead Sponsor
107 Previous Clinical Trials
36,732 Total Patients Enrolled
3 Trials studying Sleep Deprivation
144 Patients Enrolled for Sleep Deprivation
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You are pregnant, as confirmed by a urine test.You have been using nicotine regularly or have been addicted to it in the past year.You take naps more than 4 times a week, in addition to your regular sleep schedule.You are currently using illegal drugs.I have kidney disease or abnormalities.I have used sleep aids in the last 6 months.You usually go to bed after 9:00 pm on weekdays.You test positive for drugs in your urine during the screening visit.I use medications that can't be stopped for a study.I use an inhaler daily for my lung condition.You don't belong to any of the specified categories.You have metal fragments or devices inside your body that could be affected by the study.You have tested positive for nicotine or cotinine in your urine.You drink more than 4 cups of coffee a day on average.You usually wake up after 9:00 AM on weekdays.My BMI is 30 or higher, indicating obesity.You have a score of 14 or higher on the Beck Inventory Form (BDI form).I have liver disease or abnormalities.Your blood pressure is higher than 140 over 90, or your resting pulse is higher than 110.You have abnormal blood test results that show a health problem.I am currently taking calcium channel blocker medications.Your score on the Morningness-Eveningness Questionnaire is below 31 or above 69.I have a history of heart disease.You regularly sleep for less than 6 hours or more than 9 hours each night.I am currently breastfeeding, lactating, or trying to get pregnant.You have previously been unable to finish an MRI scan because you felt anxious or claustrophobic.I have been hospitalized or taken medication for a psychiatric condition.You drink a lot of alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Caffeine Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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