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Clinical Trials/NCT04273841
NCT04273841
Terminated
Not Applicable

Exploring the Impact of Sleep Deprivation and Caffeine on Operationally Relevant Complex Cognitive Processes in Medical Professionals

Walter Reed Army Institute of Research (WRAIR)1 site in 1 country7 target enrollmentJuly 6, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Deprivation
Sponsor
Walter Reed Army Institute of Research (WRAIR)
Enrollment
7
Locations
1
Primary Endpoint
Psychomotor Vigilance Task
Status
Terminated
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 6, 2017
End Date
July 9, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Walter Reed Army Institute of Research (WRAIR)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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).
  • 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)

Outcomes

Primary Outcomes

Psychomotor Vigilance Task

Time Frame: 5 days

Computer Based response time measurement

Clinical Reasoning Questions

Time Frame: 5 days

Answer clinical board questions

Secondary Outcomes

  • Actigraphy(5 days)
  • Polysomnography(5 days)
  • Structural Brain Scan-functional MRI(5 days)

Study Sites (1)

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