Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows

August 22, 2022 updated by: Alexander Hajduczok, Thomas Jefferson University
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.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Anticipated)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexander Hajduczok, MD, Thomas Jefferson University Hospital, Department of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2022

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

April 15, 2023

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Burnout

Clinical Trials on WHOOP strap 4.0

3
Subscribe