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Heart Rate Variability and Stress Management Enhancement

Primary Purpose

Burnout, Professional

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apollo Wearable
Sponsored by
Michelle Thompson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout, Professional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apollo Intervention Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 9, 2023
Last Updated
October 10, 2023
Sponsor
Michelle Thompson
Collaborators
The Board of Medicine, Apollo Neuroscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05731856
Brief Title
Heart Rate Variability and Stress Management Enhancement
Official Title
Impact of Heart Rate Variability Modulation on Stress and Recovery Among Physicians
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 9, 2025 (Anticipated)
Study Completion Date
February 9, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle Thompson
Collaborators
The Board of Medicine, Apollo Neuroscience, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apollo Intervention Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Apollo Wearable
Other Intervention Name(s)
Apollo Neuro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Copenhagen Burnout Inventory
Description
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
Time Frame
Through study completion, on average 8 weeks
Title
Perceived Stress Scale (PSS-10)
Description
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.
Time Frame
Through study completion, on average 8 weeks
Secondary Outcome Measure Information:
Title
The Quick Inventory of Depressive Symptomatology
Description
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.
Time Frame
Through study completion, on average 8 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Through study completion, on average 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adi Mittal, BS
Phone
7243474099
Email
mittal.adi@medstudent.pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Grinsell, PhD
Phone
8559220057
Email
nicole@apolloneuro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Thompson, DO
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adi Mittal, BS
Email
Mittal.Adi@medstudent.pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Heart Rate Variability and Stress Management Enhancement

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