Heart Rate Variability and Stress Management Enhancement

Study Overview
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Brief Summary
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The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects burnout in physicians.

Detailed Description
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This study will be conducted by using a Tuned Vibroacoustic Stimulation (TVS) device(the commercially available TVS device known as the Apollo wearable), that has been shown in clinical studies at University of Pittsburgh to improve heart rate variability and recovery under stress. The Apollo wearable generates low volume sound waves that feel like a soothing touch to the skin. This study will assess whether slight modulation of heart rate variability (HRV) will result in a reduction in stress, improved recovery, and recovery in and around the hospital. Physicians will wear the Apollo device for heart rate variability modulation and complete questionnaires before and after use of the Apollo device for comparison of outcomes.

Official Title
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Impact of Heart Rate Variability Modulation on Stress and Recovery Among Physicians

Conditions
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Burnout, Professional

Intervention / Treatment
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* Device: Apollo Wearable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: UPMC attending physicians and residents. The participants must have either IOS or Android phones. Exclusion Criteria: Unwillingness or inability to participate in the study Currently own an Apollo device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apollo Intervention Arm<br>Eligible UPMC Physicians and Residents who consent to be part of this study will use an Apollo Device TVS (10-200 Hz) attached to the subject's wrist or ankle via a commercially available wearable vibration technology that can deliver TVS (Transcutaneous Vibratory Stimulation). The intensity will be targeted for the sensory threshold (the level at which the vibration is just noticeable), as this is where the TVS seems most effective from prior studies. Similar vibratory stimuli have been demonstrated to be safe in the literature. The intensity of the vibration will be adjusted to the subjects' comfort and can be controlled by the subject at any time. | Device: Apollo Wearable<br>* Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phones. Participants will use the Apollo for at least 30 minutes after waking up and at least 30 minutes before bed on the corresponding settings for those times of the day. They will be given the Apollo Device TVS (10-200 Hz) to borrow, which they will be instructed to wear daily. They will be asked to wear the device until all study data is collected.<br>* Other names: Apollo Neuro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Copenhagen Burnout Inventory | The Copenhagen Burnout Inventory (CBI) is a 19-item self reported measure of burnout. It contains three sub-scales measuring personal burnout, work-related burnout, and client-related burnout | Through study completion, on average 8 weeks | 
| Perceived Stress Scale (PSS-10) | The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress using a 10-item survey. It is a measure of the degree to which situations in one's life are appraised as stressful. | Through study completion, on average 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quick Inventory of Depressive Symptomatology | The QIDS is a brief, 16-item self-rated assessment tool used to evaluate the symptoms of depression present in a patient during the past week. | Through study completion, on average 8 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. With a range of scores 1-21. | Through study completion, on average 8 weeks |