- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05513339
Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Conventional methods of qualifying personal wellbeing are limited by poor insight about the emotional and behavioral corollaries of stress and burnout (e.g., depersonalization, sleep alterations, heart rate variability). While self-care is often the preferred option for those coping with stress or burnout in challenging situations, it may be the only option in low-resource settings with limited access to professional management. Similarly, many healthcare workers and trainees acknowledge that self-care is a critical component to overall wellbeing, yet they also admit that multiple barriers interfere with the effectiveness of this practice. First, self-care interventions can only be effective if impacted persons recognize the need for interventions, act on that need, and learn which methods are effective on an individual basis. Furthermore, testing modalities (e.g., hormonal assays, polysomnography, electrophysiology) for stress and its downstream syndrome of burnout not only are prohibitively expensive, but they also require significant time and cannot be broadly disseminated within reasonable limits. As such, approaches for monitoring parameters of wellness are critically needed, and if successful, those data can allow for streamlined mental health interventions for those completing fellowship training before symptoms of burnout escalate further.
Aim 1: To determine whether physiologic metrics of sleep and heart rate variability correlate with executive function metrics post 12- or 24-hour call in a 12-month period.
Hypothesis: Less total sleep hours will correlate with lower scores on executive function testing (Stroop test).
Aim 2: To determine the physiologic effects of sleep deprivation from 12- and 24-hour call on heart rate variability, REM sleep, deep sleep and respiratory rate, over a 12-month period.
Hypothesis: Less total and restorative (REM and deep sleep) will correlate with lower executive function scores and higher call burden (frequency and duration) will be associated with a prolonged return to baseline in sleep metrics (total sleep, REM sleep, deep sleep, sleep consistency).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alexander Hajduczok, MD
- Phone Number: (215) 955-5050
- Email: alexander.hajduczok@jefferson.edu
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
-
Contact:
- Alexander Hajduczok, MD
- Phone Number: 215-955-5050
- Email: alexander.hajduczok@jefferson.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)
- Own a smart phone for Bluetooth pairing with WHOOP strap 4.0
Exclusion Criteria:
- Allergies, contraindications, or unwillingness to wear a wrist device for the study period
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cardiology Fellows
Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)
|
Subjects will wear the WHOOP strap 4.0 for continuous physiologic monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total sleep hours per night
Time Frame: 180 days
|
Sleep (hours per night) will be objectively measured nightly.
|
180 days
|
Executive function test (Stroop test), daily
Time Frame: 180 days, measured following each 24 hour call shift (weekly)
|
The Stroop test demonstrates cognitive interference where a delay in the reaction time of a task occurs due to a mismatch in stimuli. A basic task that demonstrates this effect occurs when there is a mismatch between the name of a color (e.g. "blue" or "red") and the color it is printed on (i.e the word "red" printed in blue ink instead of red ink). When asked to name the color of the word it takes longer and is more prone to errors than when the color of the ink matches the name of the color. The test consists of 3 labels, each displaying the name of a color (not necessarily tinted in the color which they denote). The subject is tasked to tap on the appropriate label at the bottom, whose text denotes the ink color of the top label. The total score is the number of correct answers in 60 seconds (+1), minus the number of incorrect answers (-1). Scores may range from 0-60, with mean scores in the range of 10-20. The stroop test will be performed daily (every morning). |
180 days, measured following each 24 hour call shift (weekly)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
REM sleep hours, nightly
Time Frame: 180 days
|
REM sleep hours will be measured nightly by the WHOOP strap 4.0.
|
180 days
|
Deep sleep hours, nightly
Time Frame: 180 days
|
Deep sleep hours will be measured nightly by the WHOOP strap 4.0.
|
180 days
|
Resting heart rate, nightly
Time Frame: 180 days
|
Resting heart rate will be measured nightly by the WHOOP strap 4.0.
|
180 days
|
Heart rate variability, nightly
Time Frame: 180 days
|
Heart rate variability will be measured nightly by the WHOOP strap 4.0.
|
180 days
|
Respiration rate, nightly
Time Frame: 180 days
|
Respiration rate will be measured nightly by the WHOOP strap 4.0.
|
180 days
|
Pulse oximetry, nightly
Time Frame: 180 days
|
Pulse oximetry will be measured nightly by the WHOOP strap 4.0.
|
180 days
|
Body temperature, nightly
Time Frame: 180 days
|
Body temperature will be measured nightly by the WHOOP strap 4.0.
|
180 days
|
Average duty hours per week
Time Frame: 180 days
|
Duty hours will be self-reported every week
|
180 days
|
Perceived Stress Scale-4 (PSS-4)
Time Frame: 180 days
|
The PSS-4 consists of 4 items that assess perceived stress.
The items are scored on a 4-point scale.
This survey will be administered biweekly.
|
180 days
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 180 days
|
The Patient Health Questionnaire-9 (PHQ-9) consists of 9 items that assess major depressive disorder.
This survey will be administered biweekly.
PHQ-9 score can range from 0 to 27, with 27 being most severe (worse).
|
180 days
|
Physician Well-Being Index (PWBI)
Time Frame: 180 days
|
The Physician Well Being Index is a 7 question survey, scored 0-7, with lower scores indicative of better physician well being.
|
180 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander Hajduczok, MD, Thomas Jefferson University Hospital, Department of Cardiology
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22D.689
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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