Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows

Sleep Deprivation Clinical Trial

Official title:

Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05513339
• Other study ID #: 22D.689
• Status: Not yet recruiting
• Start date: September 15, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: August 2022
• Source: Thomas Jefferson University
• Contact: Alexander Hajduczok, MD
• Phone: (215) 955-5050
• Email: alexander.hajduczok[@]jefferson.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A reliable method for monitoring sleep, stress, and burnout among cardiology fellows is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 21 Cardiology Fellows Thomas Jefferson University Hospital for 6 months.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: April 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout
• Executive Function
• Sleep Deprivation
• Wellness

Intervention

Device:
• WHOOP strap 4.0
Subjects will wear the WHOOP strap 4.0 for continuous physiologic monitoring.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep hours per night	Sleep (hours per night) will be objectively measured nightly.	180 days
Primary	Executive function test (Stroop test), daily	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	REM sleep hours, nightly	REM sleep hours will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Deep sleep hours, nightly	Deep sleep hours will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Resting heart rate, nightly	Resting heart rate will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Heart rate variability, nightly	Heart rate variability will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Respiration rate, nightly	Respiration rate will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Pulse oximetry, nightly	Pulse oximetry will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Body temperature, nightly	Body temperature will be measured nightly by the WHOOP strap 4.0.	180 days
Secondary	Average duty hours per week	Duty hours will be self-reported every week	180 days
Secondary	Perceived Stress Scale-4 (PSS-4)	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
Secondary	Patient Health Questionnaire-9 (PHQ-9)	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
Secondary	Physician Well-Being Index (PWBI)	The Physician Well Being Index is a 7 question survey, scored 0-7, with lower scores indicative of better physician well being.	180 days