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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Reasoning Questions
Psychomotor Vigilance Task
Secondary outcome measures
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
36,722 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this research endeavor?
"The information posted to clinicaltrials.gov indicates that this particular medical trial is no longer actively searching for participants; the last time it was updated was on April 5th 2021, and initial posting occurred July 6th 2017. Though not currently recruiting patients, there are still 50 other clinical trials which are open right now."
Answered by AI
Is this clinical trial open to individuals of all ages, particularly those past the age of fourty?
"The range of patients eligible to participate in this clinical trial is between 18 and 50 years old. Patients younger than 18 can consider one of the 7 studies available; likewise, those above 65 have 17 options at their disposal."
Answered by AI
Who is eligible to join this research endeavor?
"In order to qualify for this study, individuals who suffer from sleep deprivation and are between 18-50 years of age can apply. This trial is seeking a total of 42 participants."
Answered by AI
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