Heart Rate Variability and Stress Management Enhancement

Sponsor
Apollo Neuroscience, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05731856
Collaborator
The Board of Medicine (Other)
300
1
1
35.4
8.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Apollo Wearable
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.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)
Primary Purpose:
Supportive Care
Official Title:
Impact of Heart Rate Variability Modulation on Stress and Recovery Among Physicians
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 9, 2025
Anticipated Study Completion Date :
Feb 9, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Apollo Intervention Arm

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
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.
Other Names:
  • Apollo Neuro
  • Outcome Measures

    Primary Outcome Measures

    1. Copenhagen Burnout Inventory [Through study completion, on average 8 weeks]

      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

    2. Perceived Stress Scale (PSS-10) [Through study completion, on average 8 weeks]

      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

    1. The Quick Inventory of Depressive Symptomatology [Through study completion, on average 8 weeks]

      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.

    2. Pittsburgh Sleep Quality Index (PSQI) [Through study completion, on average 8 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Pittsburgh Pennsylvania United States 15260

    Sponsors and Collaborators

    • Apollo Neuroscience, Inc.
    • The Board of Medicine

    Investigators

    • Principal Investigator: Michelle Thompson, DO, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Apollo Neuroscience, Inc.
    ClinicalTrials.gov Identifier:
    NCT05731856
    Other Study ID Numbers:
    • STUDY22060130
    First Posted:
    Feb 16, 2023
    Last Update Posted:
    Feb 16, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 16, 2023