Sleep DeprivationNCT04273841
Impact of Sleep Deprivation and Caffeine in Medical Professionals
A study testing Military Energy Gum in people with Sleep Deprivation and Performance, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Performance
- What is being tested?
- Military Energy Gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2017to 9 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Novice group --National Capital Area Interns and Medical Students (3rd and 4th year only)
- Intermediate group - National Capital Area PGY-2 and 3 residents in internal medicine
- Expert group-Board certified internists from National Capital Area
Who cannot join
- Related to Sleep Research Center. The following exclusion criteria apply to all volunteers:
- Self-reported habitual nightly sleep amounts outside the target range of 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist)
- Self-reported nighttime lights-out times earlier than 2100 hours on average during weeknights (Sunday through Thursday) (Post-consent Checklist)
- Self-reported morning wake-up times later than 0900 on average during weekdays (Monday through Friday) (Post-consent Checklist)
- Self-reported habitual napping (> 4 time a week in conjunction with normal sleep habits) (Post-consent Checklist)
- Self-reported caffeine use in excess of 400 mg (e.g., approximately 8 caffeinated sodas or 4 12-oz cups of coffee) per day on average (Post-consent Checklist; document provides exclusionary limits for various caffeinated products).
Show all 35Show fewer
- Score of lower than 31 or higher than 69 on the Morningness-Eveningness Questionnaire (MEQ form)
- Score of 14 or above on the Beck Inventory Form (BDI form)
- Score of 41 or above on the Spielberger Trait Anxiety Inventory
- History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction) (Medical History and Examination Form)
- History of neurologic disorder (to include, but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders) (Medical History and Examination form; sleep items on Post-Consent Checklist)
- Underlying pulmonary disease requiring daily inhaler use (Medical History and Examination form)
- Kidney disease or kidney abnormalities (Medical History and Examination form, laboratory results)
- Liver disease or liver abnormalities (Medical History and Examination form, laboratory results)
- Self-reported history of psychiatric disorder requiring hospitalization or psychiatric product for any length of time (Medical History and Examination form)
- Self-reported or suspected regular nicotine use or addiction, defined as more than 1 cigarette or equivalent per week, within the last 1 year (Medical History and Examination form)
- Self-reported or suspected heavy alcohol use; minimum limit to define heavy alcohol use is 14 drinks per week or as determined by the examining study licensed physician (Medical History and Examination form)
- Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases, to be determined on a case-by-case basis by the examining study licensed physician (Medical History and Examination form)
- Self-reported or suspected current use of other illicit drugs, to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana (Medical History and Examination form)
- Positive urine pregnancy result
- Female volunteers who are breastfeeding, lactating, or actively trying to conceive
- Resting blood pressure above 140/90 or resting pulse > 110 (Medical History and Examination form). Note that if a repeat measurement is within range then the volunteer will not be excluded.
- BMI ≥ 30 (Obese Class I or greater) (Medical History and Examination form)
- Clinically significant values (as determined by the reviewing study licensed physician) for any hematology or chemistry parameter. Reviewing physician may opt to repeat any clinically significant tests and include volunteers whose repeat test values are not clinically significant.
- Positive urine nicotine/cotinine result during screening visit (NicCheck™ I test strip results)
- Positive urine drug result during screening visit
- Any use of prescription or over-the-counter sleep aids during the 6 month period prior to screening indicative of a potential sleep disorder as determined by the examining study medical investigator [e.g., use of a sleep aid for several nights following time zone travel, or the occasional use of a sleep inducing medication (e.g. 1-2 times per month), would not necessarily constitute evidence of a sleep disorder and result in disqualification].
- Not fitting into one of four categories: 1) 3rd of 4th year medical student AND native English speaker, 2) medical intern, 3) PGY-2 or PGY-3 resident in internal medicine, 4) board-certified internist (Post-consent checklist)
- Inability to read and sign the consent and HIPAA authorization form
- 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
- Related to FMRI task.
- The following exclusion criteria apply to all subjects (MR Safety Screening form):
- The presence of incompatible shrapnel or implanted devices
- A history of prior inability to complete an MRI scan due to anxiety or claustrophobia (participants will not be able to take benzodiazepines or other sedatives prior to the scan to treat anxiety, as these would adversely impact thought processes).
- Being treated with calcium channel blocker medicines (because of the potential impact of such medicines on cerebral blood flow patterns).
Trial locations and contacts
1 site in 1 country.
United States1 site
WRAIR Sleep Research Center
Silver Spring, Maryland, 20910
About this study
Official title: Exploring the Impact of Sleep Deprivation and Caffeine on Operationally Relevant Complex Cognitive Processes in Medical Professionals
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.
- Conditions
- Sleep Deprivation, Performance
- Being tested
- Military Energy Gum, Placebo Gum
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Military Energy GumDietary supplement
Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant that is found naturally in some foods and beverages such as coffee and tea. For this study, caffeine will be administered in the form of gum pellets (Military Energy chewing gum). Each pellet contains 100 mg of caffeine.
Placebo GumDietary supplement
Pellet form placebo gum
| Study group | Role | What they receive |
|---|---|---|
| Caffeine Group | Active comparator | This group will receive caffeine gum. Receives: Dietary Supplement: Military Energy Gum |
| Placebo | Placebo comparator | This group will receive gum without caffeine. Receives: Dietary Supplement: Placebo Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Task
Computer Based response time measurement
Measured: 5 days
Clinical Reasoning Questions
Answer clinical board questions
Measured: 5 days
Secondary outcomes (3)
Actigraphy
Wrist movement and activity monitoring
Measured: 5 days
Polysomnography
Measurement of brain activity
Measured: 5 days
Structural Brain Scan-functional MRI
Measurement of structural brain topography to localize areas of functional activation using a functional MRI scan
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start6 Jul 2017
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Why it stopped: Currently this study is unfunded, but WRAIR Principal Investigator (PI) and USUHS Site PI, will continue to search for restoral or Unfunded Requirement (UFR) funds that can resurrect this protocol and allow the opportunity to collect data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273841
- Sponsor's protocol ID
- WRAIR #2311
- Status last verified
- May 2025
- First submitted
- 5 Sep 2019
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Sleep Deprivation and Caffeine on Operationally Relevant Complex Cognitive Processes in Medical Professionals
- ClinicalTrials.gov ID
- NCT04273841
- Acronym / sponsor ID
- WRAIR #2311
- Conditions
- Sleep Deprivation, Performance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Currently this study is unfunded, but WRAIR Principal Investigator (PI) and USUHS Site PI, will continue to search for restoral or Unfunded Requirement (UFR) funds that can resurrect this protocol and allow the opportunity to collect data.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine Group | Active comparator | Dietary Supplement: Military Energy GumThis group will receive caffeine gum. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo GumThis group will receive gum without caffeine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Novice group --National Capital Area Interns and Medical Students (3rd and 4th year only)
- Intermediate group - National Capital Area PGY-2 and 3 residents in internal medicine
- Expert group-Board certified internists from National Capital Area
Key exclusion criteria (35 listed)
- Related to Sleep Research Center. The following exclusion criteria apply to all volunteers:
- Self-reported habitual nightly sleep amounts outside the target range of 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average) (Post-consent Checklist)
- Self-reported nighttime lights-out times earlier than 2100 hours on average during weeknights (Sunday through Thursday) (Post-consent Checklist)
- Self-reported morning wake-up times later than 0900 on average during weekdays (Monday through Friday) (Post-consent Checklist)
- Self-reported habitual napping (> 4 time a week in conjunction with normal sleep habits) (Post-consent Checklist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Military Energy GumCaffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant that is found naturally in some foods and beverages such as coffee and tea. For this study, caffeine will be administered in the form of gum pellets (Military Energy chewing gum). Each pellet contains 100 mg of caffeine. | Dietary supplement | Caffeine Group |
| Placebo GumPellet form placebo gum | Dietary supplement | Placebo |
Primary outcome
Psychomotor Vigilance Task
Time frame: 5 days
Computer Based response time measurement
Clinical Reasoning Questions
Time frame: 5 days
Answer clinical board questions
3 secondary outcomes
Actigraphy
Time frame: 5 days
Polysomnography
Time frame: 5 days
Structural Brain Scan-functional MRI
Time frame: 5 days
Results and safety
The study was stopped early (reason given: Currently this study is unfunded, but WRAIR Principal Investigator (PI) and USUHS Site PI, will continue to search for restoral or Unfunded Requirement (UFR) funds that can resurrect this protocol and allow the opportunity to collect data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Military Energy Gum in people with Sleep Deprivation and Performance, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Currently this study is unfunded, but WRAIR Principal Investigator (PI) and USUHS Site PI, will continue to search for restoral or Unfunded Requirement (UFR) funds that can resurrect this protocol and allow the opportunity to collect data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor Vigilance Task (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.