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Impact of Sleep Deprivation and Caffeine in Medical Professionals

Primary Purpose

Sleep Deprivation, Performance

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Military Energy Gum
Placebo Gum
Sponsored by
Walter Reed Army Institute of Research (WRAIR)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Deprivation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Novice group --National Capital Area Interns and Medical Students (3rd and 4th year only)
  2. Intermediate group - National Capital Area PGY-2 and 3 residents in internal medicine
  3. 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)
  • 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).

Sites / Locations

  • WRAIR Sleep Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Caffeine Group

Placebo

Arm Description

This group will receive caffeine gum.

This group will receive gum without caffeine.

Outcomes

Primary Outcome Measures

Psychomotor Vigilance Task
Computer Based response time measurement
Clinical Reasoning Questions
Answer clinical board questions

Secondary Outcome Measures

Actigraphy
Wrist movement and activity monitoring
Polysomnography
Measurement of brain activity
Structural Brain Scan-functional MRI
Measurement of structural brain topography to localize areas of functional activation using a functional MRI scan

Full Information

First Posted
September 5, 2019
Last Updated
April 28, 2023
Sponsor
Walter Reed Army Institute of Research (WRAIR)
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1. Study Identification

Unique Protocol Identification Number
NCT04273841
Brief Title
Impact of Sleep Deprivation and Caffeine in Medical Professionals
Official Title
Exploring the Impact of Sleep Deprivation and Caffeine on Operationally Relevant Complex Cognitive Processes in Medical Professionals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
October 12, 2026 (Anticipated)
Study Completion Date
October 12, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed Army Institute of Research (WRAIR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Performance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caffeine Group
Arm Type
Active Comparator
Arm Description
This group will receive caffeine gum.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group will receive gum without caffeine.
Intervention Type
Dietary Supplement
Intervention Name(s)
Military Energy Gum
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Gum
Intervention Description
Pellet form placebo gum
Primary Outcome Measure Information:
Title
Psychomotor Vigilance Task
Description
Computer Based response time measurement
Time Frame
5 days
Title
Clinical Reasoning Questions
Description
Answer clinical board questions
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Actigraphy
Description
Wrist movement and activity monitoring
Time Frame
5 days
Title
Polysomnography
Description
Measurement of brain activity
Time Frame
5 days
Title
Structural Brain Scan-functional MRI
Description
Measurement of structural brain topography to localize areas of functional activation using a functional MRI scan
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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) 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).
Facility Information:
Facility Name
WRAIR Sleep Research Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Sleep Deprivation and Caffeine in Medical Professionals

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