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NCT Number: NCT05731856

Impact of Heart Rate Variability Modulation on Stress Management Among Physicians

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.

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Key information

Conditions

Burnout, Professional Behavior Behavioral Symptoms Burnout, Psychological Occupational Diseases Occupational Stress Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location status: Recruiting

Location contact

Franchesca Inay, BS

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apollo Wearable

Device

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

Primary outcomes

  1. Copenhagen Burnout Inventory

    Time frame: 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)

    Time frame: 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 outcomes

  1. The Quick Inventory of Depressive Symptomatology

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Franchesca Inay, BS

CONTACT

[email protected]

5512234990

Mahi Mandala, PhD

CONTACT

[email protected]

4129450345

Sponsors and collaborators

Lead sponsor

Michelle Thompson

Other

Collaborators

  • Apollo Neuroscience, Inc.
  • The Board of Medicine

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 16, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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