WellnessNCT05513339
Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
An observational study of Wellness and Burnout, run by Thomas Jefferson University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Wellness, Burnout, Sleep Deprivation
- What is being tested?
- WHOOP strap 4.0
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 15 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)
Who may be able to join
- Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)
- Own a smart phone for Bluetooth pairing with WHOOP strap 4.0
Who cannot join
- Allergies, contraindications, or unwillingness to wear a wrist device for the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Alexander Hajduczok, MD, 215-955-5050, alexander.hajduczok@jefferson.edu
About this study
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.
Read the 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).
- Conditions
- Wellness, Burnout, Sleep Deprivation, Executive Function
- Being tested
- WHOOP strap 4.0
- Keywords
- WHOOP strap 4.0, Remote Monitoring
- Medical subject headings
- Burnout, Psychological, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOOP strap 4.0Device
Subjects will wear the WHOOP strap 4.0 for continuous physiologic monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Cardiology Fellows | Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6) Receives: Device: WHOOP strap 4.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep hours per night
Sleep (hours per night) will be objectively measured nightly.
Measured: 180 days
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).
Measured: 180 days, measured following each 24 hour call shift (weekly)
Secondary outcomes (11)
REM sleep hours, nightly
REM sleep hours will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Deep sleep hours, nightly
Deep sleep hours will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Resting heart rate, nightly
Resting heart rate will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Heart rate variability, nightly
Heart rate variability will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Respiration rate, nightly
Respiration rate will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Pulse oximetry, nightly
Pulse oximetry will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Body temperature, nightly
Body temperature will be measured nightly by the WHOOP strap 4.0.
Measured: 180 days
Average duty hours per week
Duty hours will be self-reported every week
Measured: 180 days
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.
Measured: 180 days
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).
Measured: 180 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start15 Sep 2022 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellnessStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Hajduczok, Thomas Jefferson University
- Investigators
- Alexander Hajduczok, MD, Principal investigator, Thomas Jefferson University Hospital, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513339
- Sponsor's protocol ID
- 22D.689
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
- ClinicalTrials.gov ID
- NCT05513339
- Acronym / sponsor ID
- 22D.689
- Conditions
- Wellness, Burnout, Sleep Deprivation, Executive Function
- Keywords
- WHOOP strap 4.0, Remote Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiology Fellows | – | Device: WHOOP strap 4.0Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)
Key inclusion criteria (2 listed)
- Cardiology fellows at Thomas Jefferson University Hospital (PGY4-PGY6)
- Own a smart phone for Bluetooth pairing with WHOOP strap 4.0
Key exclusion criteria (1 listed)
- Allergies, contraindications, or unwillingness to wear a wrist device for the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHOOP strap 4.0Subjects will wear the WHOOP strap 4.0 for continuous physiologic monitoring. | Device | Cardiology Fellows |
Primary outcome
Total sleep hours per night
Time frame: 180 days
Sleep (hours per night) will be objectively measured nightly.
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).
11 secondary outcomes
REM sleep hours, nightly
Time frame: 180 days
Deep sleep hours, nightly
Time frame: 180 days
Resting heart rate, nightly
Time frame: 180 days
Heart rate variability, nightly
Time frame: 180 days
Respiration rate, nightly
Time frame: 180 days
Pulse oximetry, nightly
Time frame: 180 days
Body temperature, nightly
Time frame: 180 days
Average duty hours per week
Time frame: 180 days
Perceived Stress Scale-4 (PSS-4)
Time frame: 180 days
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 180 days
Physician Well-Being Index (PWBI)
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Hajduczok, MD principal investigator
Thomas Jefferson University Hospital, Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wellness and Burnout, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Hajduczok, MD ((215) 955-5050, alexander.hajduczok@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep hours per night (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.