Impact of Sleep Deprivation and Caffeine in Medical Professionals

NCT04273841 | Terminated

• 1 other identifier: WRAIR #2311
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Psychomotor Vigilance Task

  Computer Based response time measurement

  5 days

• Clinical Reasoning Questions

  Answer clinical board questions

  5 days

Secondary Outcomes (3)

• Actigraphy

  5 days

• Polysomnography

  5 days

• Structural Brain Scan-functional MRI

  5 days

Study Arms (2)

Caffeine Group

ACTIVE COMPARATOR

This group will receive caffeine gum.

Dietary Supplement: Military Energy Gum

Placebo

PLACEBO COMPARATOR

This group will receive gum without caffeine.

Dietary Supplement: Placebo Gum

Interventions

Military Energy Gum DIETARY_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.

Caffeine Group

Placebo Gum DIETARY_SUPPLEMENT

Pellet form placebo gum

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR): lead

Study Sites (1)

WRAIR Sleep Research Center

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: February 18, 2020
• Study Start: July 6, 2017
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)