Heart Rate Variability and Stress Management Enhancement

Burnout, Professional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731856
• Other study ID #: STUDY22060130
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: February 9, 2026

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Franchesca Inay, BS
• Phone: 4123104150
• Email: inay.franchesca[@]medstudent.pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 9, 2026
• Est. primary completion date: December 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Michelle Thompson	Apollo Neuroscience, Inc., The Board of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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